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1.
Intensive Care Med ; 2024 Jul 29.
Artigo em Inglês | MEDLINE | ID: mdl-39073580

RESUMO

PURPOSE: Although noninvasive ventilation (NIV) may reduce reintubation in patients with acute hypoxemic respiratory failure following abdominal surgery, this strategy has not been specifically assessed in patients with obesity. METHODS: We conducted a post hoc analysis of a multicenter randomized controlled trial comparing NIV delivered via facial mask to standard oxygen therapy among patients with obesity and acute hypoxemic respiratory failure within 7 days after abdominal surgery. The primary outcome was reintubation within 7 days. Secondary outcomes were invasive ventilation-free days at day 30, intensive care unit (ICU)-acquired pneumonia and 30-day survival. RESULTS: Among 293 patients with hypoxemic respiratory failure following abdominal surgery, 76 (26%) patients had obesity and were included in the intention-to-treat analysis. Reintubation rate was significantly lower with NIV (13/42, 31%) than with standard oxygen therapy (19/34, 56%) within 7 days (absolute difference: - 25%, 95% confidence interval (CI) - 49 to - 1%, p = 0.03). NIV was associated with significantly more invasive ventilation-free days compared with standard oxygen therapy (27.1 ± 8.6 vs 22.7 ± 11.1 days; p = 0.02), while fewer patients developed ICU-acquired pneumonia (1/42, 2% vs 6/34, 18%; p = 0.04). The 30-day survival was 98% in the NIV group (41/42) versus 85% in the standard oxygen therapy (p = 0.08). In patients with body mass index (BMI) < 30 kg/m2, no significant difference was observed between NIV (36/105, 34%) and standard oxygen therapy (47/109, 43%, p = 0.03). An interaction test showed no statistically significant difference between the two subsets (BMI ≥ 30 kg/m2 and BMI < 30 kg/m2). CONCLUSIONS: Among patients with obesity and hypoxemic respiratory failure following abdominal surgery, use of NIV compared with standard oxygen therapy reduced the risk of reintubation within 7 days, contrary to patients without obesity. However, no interaction was found according to the presence of obesity or not, suggesting either a lack of power to conclude in the non-obese subgroup despite existing differences, or that the statistical difference found in the overall sample was driven by a large effect in the obese subsets.

2.
J Immunother Cancer ; 11(5)2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-37258037

RESUMO

BACKGROUND: Immune checkpoint inhibitors (ICI) have transformed cancer treatment over the last decade. Alongside this therapeutic improvement, a new variety of side effects has emerged, called immune-related adverse events (irAEs), potentially affecting any organ. Among these irAEs, myocarditis is rare but life-threatening. METHODS: We conducted a multicenter cross-sectional retrospective study with the aim of better characterizing ICI-related myocarditis. Myocarditis diagnosis was based on the recent consensus statement of the International Cardio-Oncology Society. RESULTS: Twenty-nine patients were identified, from six different referral centers. Most patients (55%) were treated using anti-programmed-death 1, rather than ICI combination (35%) or anti-programmed-death-ligand 1 (10%). Transthoracic echocardiography was abnormal in 52% of them, and cardiac magnetic resonance showed abnormal features in 14/24 patients (58%). Eleven patients (38%) were classified as severe. Compared with other patients, they had more frequently pre-existing systemic autoimmune disease (45% vs 6%, p=0.018), higher troponin level on admission (42-fold the upper limit vs 3.55-fold, p=0.001), and exhibited anti-acetylcholine receptor autoantibodies (p=0.001). Seven patients (24%) had myocarditis-related death, and eight more patients died from cancer progression during follow-up. Twenty-eight patients received glucocorticoids, 10 underwent plasma exchanges, 8 received intravenous immunoglobulins, and 5 other immunosuppressants. ICI rechallenge was performed in six patients, with only one myocarditis relapse. DISCUSSION: The management of ICI-related myocarditis may be challenging and requires a multidisciplinary approach. Prognostic features are herein described and may help to allow ICI rechallenge for some patients with smoldering presentation, after an accurate evaluation of benefit-risk balance.


Assuntos
Antineoplásicos Imunológicos , Miocardite , Neoplasias , Humanos , Miocardite/induzido quimicamente , Miocardite/diagnóstico , Miocardite/tratamento farmacológico , Inibidores de Checkpoint Imunológico/efeitos adversos , Antineoplásicos Imunológicos/efeitos adversos , Estudos Retrospectivos , Estudos Transversais , Neoplasias/tratamento farmacológico , Prognóstico
3.
Updates Surg ; 75(3): 553-561, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-36376559

RESUMO

Risk factors for gastrointestinal (GI) perforations in adult liver transplantation (LT) recipients have never been deeply investigated, as well as their management. The aim of this study is to report a single-center 10 years' experience about GI perforations after LT, focusing on risk factors and management strategies according to an international survey involving expert transplant surgeons. Data regarding all consecutive patients undergoing liver transplantations from January 2009 until December 2019 in a single institution were retrospectively collected. Risk factors for GI perforation were investigated. A web survey about the management of gastrointestinal perforations was conducted among worldwide transplantation centers. On 699 adult liver transplantations performed in our center, 20 cases of GI perforations were found, with an incidence of 2.8%. A previous abdominal surgery was found to be the only risk factor (p = 0.01). Ninety-day mortality was 75%. According to the survey, a more conservative treatment was suggested in case of gastric and duodenal perforations (consisting in a direct suture or an external drain), while a more aggressive treatment was adopted for ileal or colic perforation (stoma with or without resection). The W value for inter-personal agreement was 0.41. Despite rare, GI perforations in LT recipients can represent a life-threatening complication. Surgical management can be challenging and depends on both the site of perforation and the clinical conditions of the patient.


Assuntos
Traumatismos Abdominais , Perfuração Intestinal , Transplante de Fígado , Adulto , Humanos , Estudos Retrospectivos , Transplante de Fígado/efeitos adversos , Perfuração Intestinal/etiologia , Perfuração Intestinal/cirurgia , Fatores de Risco
4.
Crit Care ; 26(1): 282, 2022 09 19.
Artigo em Inglês | MEDLINE | ID: mdl-36123713

RESUMO

BACKGROUND: Molecular Adsorbent Recirculating System (MARS®) is a non-biological artificial liver device. The benefit risk ratio between uncertain clinical effects and potential adverse events remains difficult to assess. We sought to describe adverse events related to MARS® therapy as well as biological and clinical effects. METHODS: All intensive care unit (ICU) admissions to whom MARS® therapy was prescribed from March 2005 to August 2021 were consecutively and prospectively included. The main endpoint was the incidence of adverse events related to MARS® therapy. Secondary endpoints were the biological and clinical effects of MARS® therapy. RESULTS: We reported 180 admissions treated with MARS® therapy. Among the 180 admissions, 56 (31.1%) were for acute-on-chronic liver failure, 32 (17.8%) for acute liver failure, 28 (15.5%) for post-surgery liver failure, 52 (28.9%) for pruritus and 12 (6.7%) for drug intoxication. At least one adverse event occurred in 95 (52.8%) admissions. Thrombocytopenia was the most frequent adverse event which was recorded in 55 admissions (30.6%). Overall, platelets count was 131 (± 95) × 109/L before and 106 (± 72) × 109/L after MARS® therapy (p < .001). After MARS® therapy, total bilirubin was significantly decreased in all groups (p < 0.05). Hepatic encephalopathy significantly improved in both the acute-on-chronic and in the acute liver failure group (p = 0.01). In the pruritus group, pruritus intensity score was significantly decreased after MARS® therapy (p < 0.01). CONCLUSION: In this large cohort of patients treated with MARS® therapy we report frequent adverse events. Thrombocytopenia was the most frequent adverse event. In all applications significant clinical and biological improvements were shown with MARS® therapy.


Assuntos
Falência Hepática Aguda , Transplante de Fígado , Desintoxicação por Sorção , Trombocitopenia , Bilirrubina , Humanos , Unidades de Terapia Intensiva , Falência Hepática Aguda/etiologia , Falência Hepática Aguda/terapia , Prurido/etiologia , Prurido/terapia , Desintoxicação por Sorção/efeitos adversos , Trombocitopenia/etiologia , Trombocitopenia/terapia , Resultado do Tratamento
5.
Intensive Care Med ; 48(9): 1176-1184, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35974189

RESUMO

PURPOSE: To investigate the impact of Macintosh blade size used during direct laryngoscopy (DL) on first-attempt intubation success of orotracheal intubation in French intensive care units (ICUs). We hypothesized that success rate would be higher with Macintosh blade size No3 than with No4. METHODS: Multicenter retrospective observational study based on data from prospective trials conducted in 48 French ICUs of university, and general and private hospitals. After each intubation using Macintosh DL, patients' and operators' characteristics, Macintosh blade size, results of first DL and alternative techniques used, as well as the need of a second operator were collected. Complications rates associated with intubation were investigated. Primary outcome was success rate of first DL using Macintosh blade. RESULTS: A total of 2139 intubations were collected, 629 with a Macintosh blade No3 and 1510 with a No4. Incidence of first-pass intubation after first DL was significantly higher with Macintosh blade No3 (79.5 vs 73.3%, p = 0.0025), despite equivalent Cormack-Lehane scores (p = 0.48). Complications rates were equivalent between groups. Multivariate analysis concluded to a significant impact of Macintosh blade size on first DL success in favor of blade No3 (OR 1.44 [95% CI 1.14-1.84]; p = 0.0025) without any significant center effect on the primary outcome (p = 0.18). Propensity scores and adjustment analyses concluded to equivalent results. CONCLUSION: In the present study, Macintosh blade No3 was associated with improved first-passed DL in French ICUs. However, study design requires the conduct of a nationwide prospective multicenter randomized trial in different settings to confirm these results.


Assuntos
Laringoscópios , Humanos , Unidades de Terapia Intensiva , Intubação Intratraqueal/efeitos adversos , Intubação Intratraqueal/métodos , Laringoscopia/métodos , Estudos Prospectivos
6.
Br J Anaesth ; 129(4): 624-634, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-35811139

RESUMO

BACKGROUND: Using a Macintosh-style videolaryngoscope as a first-intention device for tracheal intubation of unselected patients in the operating room has not often been studied. We hypothesised that using a Macintosh-style videolaryngoscope as a first-intention device is associated with an increased proportion of easy tracheal intubation. METHODS: In a quality improvement project for airway management aimed at implementing a Macintosh-style videolaryngoscope as a first-intention device, we included all consecutive tracheal intubations in adults from March, 2017 to September, 2020 in two French teaching hospitals. We divided the cohort into three temporal cohorts: the pre-intervention, implementation, and post-intervention periods. The primary outcome was the proportion of easy airway management. The secondary outcomes were the rescue technique, Cormack-Lehane III or IV view, and operator-reported difficulty of intubation. Data from one hospital compliant with the quality improvement project were compared with data from a non-compliant hospital. RESULTS: A total of 26 692 tracheal intubations were performed. Among 11 938 intubations included in the compliant hospital, 5487 were included in the pre-intervention, 1845 in the implementation, and 4606 in the post-intervention periods. In comparison to the pre-intervention period, the proportions of easy tracheal intubation increased from 94.3% (5177 of 5487) to 98.7% (4547 of 4606)) in the post-intervention period (+4.4% [95% confidence interval 3.7-5.1%], P<0.001). In comparison to the pre-intervention period, all secondary outcome proportions were significantly lower in the post-intervention period. No significant changes were noted in the non-compliant hospital between the pre- and post-intervention periods. CONCLUSIONS: Using a Macintosh-style videolaryngoscope as a first-intention device for tracheal intubation in the operating room was associated with a significant increase in the proportion of easy tracheal intubation, compared with use of the standard Macintosh laryngoscope.


Assuntos
Laringoscópios , Adulto , Hospitais de Ensino , Humanos , Intenção , Intubação Intratraqueal/métodos , Laringoscopia/métodos
7.
BMJ Open ; 12(5): e054823, 2022 05 06.
Artigo em Inglês | MEDLINE | ID: mdl-35523498

RESUMO

IntroductionEmergency abdominal surgery is associated with a high risk of postoperative complications. One of the most serious is postoperative respiratory failure (PRF), with reported rates up to 20%-30% and attributable 30-day mortality that can exceed 20%.Lung-protective ventilation, especially the use of low tidal volume, may help reducing the risk of lung injury. The role of positive end-expiratory pressure (PEEP) and recruitment manoeuvre (RM) remains however debated. We aim to evaluate whether a strategy aimed at increasing alveolar recruitment by using higher PEEP levels and RM could be more effective at reducing PRF and mortality after emergency abdominal surgery than a strategy aimed at minimising alveolar distension by using lower PEEP levels without RM. METHODS AND ANALYSIS: The IMPROVE-2 study is a multicentre randomised, parallel-group clinical trial of 680 patients requiring emergency abdominal surgery under general anaesthesia. Patients will be randomly allocated in a 1:1 ratio to receive either low PEEP levels (≤5 cm H2O) without RM or high PEEP levels individually adjusted according to driving pressure in addition to RM, stratified by centre and according to the presence of shock and hypoxaemia at randomisation. The primary endpoint is a composite of PRF and all-cause mortality by day 30 or hospital discharge. Data will be analysed on the intention-to-treat principle and a per-protocol basis. ETHICS AND DISSEMINATION: IMPROVE-2 trial has been approved by an independent ethics committee for all study centres. Participant recruitment began in February 2021. Results will be submitted for publication in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03987789.


Assuntos
Respiração Artificial , Insuficiência Respiratória , Abdome/cirurgia , Humanos , Estudos Multicêntricos como Assunto , Respiração com Pressão Positiva/métodos , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Respiração Artificial/métodos , Insuficiência Respiratória/prevenção & controle , Volume de Ventilação Pulmonar
8.
Anesthesiology ; 135(3): 442-453, 2021 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-34195767

RESUMO

BACKGROUND: Pectoral nerve blocks have been proposed for analgesia during and after breast cancer surgery, but data are conflicted in aesthetic breast surgery. This trial tested the primary hypothesis that adding a preincisional pectoral nerve block is superior to systemic multimodal analgesic regimen alone for pain control after breast augmentation surgery. A second hypothesis is that rescue opioid consumption would be decreased with a long-lasting effect for both outcomes during the following days. METHODS: Seventy-three adult female patients undergoing aesthetic breast augmentation surgery under general anesthesia were randomly allocated to receive a pectoral nerve block versus no block. Both groups received standard care with protocolized multimodal analgesia alone including systematic acetaminophen and nonsteroidal anti-inflammatory drugs. The primary outcome measure was the maximal numerical rating scale in the first 6 h after extubation. Secondary outcomes included intraoperative remifentanil consumption and from extubation to day 5: maximal numerical rating scale, postoperative cumulative opioid consumption and postoperative opioid side effects, and patient satisfaction recorded at day 5. RESULTS: The maximal numerical rating scale score in the first 6 h was lower in the pectoral nerve block group compared with the control group (3.9 ± 2.5 vs. 5.2 ± 2.2; difference: -1.2 [95% CI, -2.3 to -0.1]; P = 0.036). The pectoral nerve block group had a lower maximal numerical rating scale between days 1 and 5 (2.2 ± 1.9 vs. 3.2 ± 1.7; P = 0.032). The cumulative amount of overall opioids consumption (oral morphine equivalent) was lower for the pectoral nerve block group from hour 6 to day 1 (0.0 [0.0 to 21.0] vs. 21.0 [0.0 to 31.5] mg, P = 0.006) and from days 1 to 5 (0.0 [0.0 to 21.0] vs. 21.0 [0.0 to 51] mg, P = 0.002). CONCLUSIONS: Pectoral nerve block in conjunction with multimodal analgesia provides effective perioperative pain relief after aesthetic breast surgery and is associated with reduced opioid consumption over the first 5 postoperative days.


Assuntos
Bloqueio Nervoso Autônomo/métodos , Mamoplastia/efeitos adversos , Dor Pós-Operatória/prevenção & controle , Nervos Torácicos , Adulto , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Dor Pós-Operatória/diagnóstico , Estudos Prospectivos
9.
Anesthesiology ; 134(4): 541-551, 2021 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-33630043

RESUMO

BACKGROUND: It is speculated that opioid-free anesthesia may provide adequate pain control while reducing postoperative opioid consumption. However, there is currently no evidence to support the speculation. The authors hypothesized that opioid-free balanced anesthetic with dexmedetomidine reduces postoperative opioid-related adverse events compared with balanced anesthetic with remifentanil. METHODS: Patients were randomized to receive a standard balanced anesthetic with either intraoperative remifentanil plus morphine (remifentanil group) or dexmedetomidine (opioid-free group). All patients received intraoperative propofol, desflurane, dexamethasone, lidocaine infusion, ketamine infusion, neuromuscular blockade, and postoperative lidocaine infusion, paracetamol, nefopam, and patient-controlled morphine. The primary outcome was a composite of postoperative opioid-related adverse events (hypoxemia, ileus, or cognitive dysfunction) within the first 48 h after extubation. The main secondary outcomes were episodes of postoperative pain, opioid consumption, and postoperative nausea and vomiting. RESULTS: The study was stopped prematurely because of five cases of severe bradycardia in the dexmedetomidine group. The primary composite outcome occurred in 122 of 156 (78%) dexmedetomidine group patients compared with 105 of 156 (67%) in the remifentanil group (relative risk, 1.16; 95% CI, 1.01 to 1.33; P = 0.031). Hypoxemia occurred 110 of 152 (72%) of dexmedetomidine group and 94 of 155 (61%) of remifentanil group patients (relative risk, 1.19; 95% CI, 1.02 to 1.40; P = 0.030). There were no differences in ileus or cognitive dysfunction. Cumulative 0 to 48 h postoperative morphine consumption (11 mg [5 to 21] versus 6 mg [0 to 17]) and postoperative nausea and vomiting (58 of 157 [37%] versus 37 of 157 [24%]; relative risk, 0.64; 95% CI, 0.45 to 0.90) were both less in the dexmedetomidine group, whereas measures of analgesia were similar in both groups. Dexmedetomidine patients had more delayed extubation and prolonged postanesthesia care unit stay. CONCLUSIONS: This trial refuted the hypothesis that balanced opioid-free anesthesia with dexmedetomidine, compared with remifentanil, would result in fewer postoperative opioid-related adverse events. Conversely, it did result in a greater incidence of serious adverse events, especially hypoxemia and bradycardia.


Assuntos
Analgésicos não Narcóticos/uso terapêutico , Analgésicos Opioides/uso terapêutico , Anestesia Balanceada/métodos , Dexmedetomidina/uso terapêutico , Dor Pós-Operatória/tratamento farmacológico , Remifentanil/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Método Simples-Cego , Resultado do Tratamento
10.
Reg Anesth Pain Med ; 46(4): 322-327, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33563767

RESUMO

BACKGROUND: The sensory innervation of the lower jaw mainly depends on the third root of the trigeminal nerve, the mandibular nerve (V3). The aim of this single-center, prospective, randomized, double-blind, placebo-controlled study was to evaluate the effectiveness of bilateral V3 block for postoperative analgesia management in mandibular osteotomies. METHODS: 107 patients undergoing mandibular surgery (75 scheduled osteotomies and 32 mandible fractures) were randomized in two groups. A bilateral V3 block was performed in each group, either with ropivacaine 0.75% (block group, n=50) or with a placebo (placebo group, n=57). A postoperative multimodal analgesia was equally provided to both groups. The primary outcome was the cumulative morphine consumption at 24 hours. Secondary outcomes were the occurrence of severe pain and the incidence of postoperative nausea and vomiting (PONV) in the first 24 hours. Data were analyzed on an intention-to-treat basis. RESULTS: The cumulative morphine consumption at 24 hours was significantly lower in the block group (median 8.0 mg (IQR 2.0-21.3) vs 12.0 mg (IQR 8.0-22.0), p=0.03), as well as the incidence of severe pain during the 24 hours of follow-up (4.0% vs 22.8%, p<0.01). The mandibular block had no impact on the incidence of PONV. CONCLUSION: Bilateral V3 block for mandibular osteotomies is an effective opioid-sparing procedure. It provided better postoperative analgesia in the first 24 hours, and it did not affect PONV incidence. TRIAL REGISTRATION NUMBER: NCT02618993.


Assuntos
Morfina , Bloqueio Nervoso , Analgésicos Opioides , Anestésicos Locais , Método Duplo-Cego , Humanos , Mandíbula , Osteotomia Mandibular , Medição da Dor , Dor Pós-Operatória , Estudos Prospectivos , Resultado do Tratamento
11.
Anaesth Crit Care Pain Med ; 39(3): 341-343, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32360979
12.
Intensive Care Med ; 44(9): 1493-1501, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30128592

RESUMO

PURPOSE: The intensity of procedural pain in intensive care unit (ICU) patients is well documented. However, little is known about procedural pain distress, the psychological response to pain. METHODS: Post hoc analysis of a multicenter, multinational study of procedural pain. Pain distress was measured before and during procedures (0-10 numeric rating scale). Factors that influenced procedural pain distress were identified by multivariable analyses using a hierarchical model with ICU and country as random effects. RESULTS: A total of 4812 procedures were recorded (3851 patients, 192 ICUs, 28 countries). Pain distress scores were highest for endotracheal suctioning (ETS) and tracheal suctioning, chest tube removal (CTR), and wound drain removal (median [IQRs] = 4 [1.6, 1.7]). Significant relative risks (RR) for a higher degree of pain distress included certain procedures: turning (RR = 1.18), ETS (RR = 1.45), tracheal suctioning (RR = 1.38), CTR (RR = 1.39), wound drain removal (RR = 1.56), and arterial line insertion (RR = 1.41); certain pain behaviors (RR = 1.19-1.28); pre-procedural pain intensity (RR = 1.15); and use of opioids (RR = 1.15-1.22). Patient-related variables that significantly increased the odds of patients having higher procedural pain distress than pain intensity were pre-procedural pain intensity (odds ratio [OR] = 1.05); pre-hospital anxiety (OR = 1.76); receiving pethidine/meperidine (OR = 4.11); or receiving haloperidol (OR = 1.77) prior to the procedure. CONCLUSIONS: Procedural pain has both sensory and emotional dimensions. We found that, although procedural pain intensity (the sensory dimension) and distress (the emotional dimension) may closely covary, there are certain factors than can preferentially influence each of the dimensions. Clinicians are encouraged to appreciate the multidimensionality of pain when they perform procedures and use this knowledge to minimize the patient's pain experience.


Assuntos
Cuidados Críticos/estatística & dados numéricos , Emoções , Dor Processual/psicologia , Estresse Psicológico/etiologia , Idoso , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Estudos Prospectivos , Procedimentos Cirúrgicos Operatórios/efeitos adversos
13.
BMJ Open ; 8(6): e020873, 2018 06 30.
Artigo em Inglês | MEDLINE | ID: mdl-29961015

RESUMO

INTRODUCTION: Reducing opioid consumption during and after surgery has been recommended for more than 10 years. Opioid-free anaesthesia (OFA) is a multimodal anaesthesia associating hypnotics, NMDA antagonists, local anaesthetics, anti-inflammatory drugs and α-2 agonists. Proofs of the effect of OFA on reducing opioid-related adverse effects after major or intermediate non-cardiac surgery are still scarce. We hypothesised that the reduced opioid consumption allowed by OFA compared with standard of care will be associated with a reduction of postoperative opioid-related adverse events. METHODS/ANALYSIS: The POFA trial is a prospective, randomised, parallel, single-blind, multicentre study of 400 patients undergoing elective intermediate or major non-cardiac surgery. Patients will be randomly allocated to receive either a standard anaesthesia protocol or an OFA. The primary outcome measure is the occurrence of a severe postoperative opioid-related adverse event within the first 48 hours after extubation defined as: postoperative hypoxaemia or postoperative ileus or postoperative cognitive dysfunction. In addition, each component of the primary outcome measure will be analysed separately. Data will be analysed on the intention-to-treat principle and a per-protocol basis. ETHICS AND DISSEMINATION: The POFA trial has been approved by an independent ethics committee for all study centres. Participant recruitment begins in November 2017. Results will be published in international peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: NCT03316339; Pre-results.


Assuntos
Analgésicos Opioides/administração & dosagem , Anestesia Geral/efeitos adversos , Dexmedetomidina/uso terapêutico , Hipnóticos e Sedativos/uso terapêutico , Dor Pós-Operatória/prevenção & controle , Analgésicos Opioides/efeitos adversos , Método Duplo-Cego , Esquema de Medicação , Procedimentos Cirúrgicos Eletivos , Feminino , França , Humanos , Cuidados Intraoperatórios/métodos , Masculino , Estudos Multicêntricos como Assunto , Complicações Pós-Operatórias/induzido quimicamente , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto
14.
Trials ; 19(1): 307, 2018 Jun 04.
Artigo em Inglês | MEDLINE | ID: mdl-29866205

RESUMO

BACKGROUND: Delirium during intensive care unit (ICU) stay is frequent and associated with significant morbidity, mortality and healthcare-related costs. International guidelines suggest its prevention. However, curative treatment remains unclearly established. Despite contradictory and ambiguous academic literature, international guidelines suggest the use of second-generation (atypical) antipsychotics over haloperidol. However, haloperidol remains the most widely used neuroleptic worldwide as a first-line treatment of agitation and/or delirium. Dexmedetomidine, an alpha2-adrenergic receptors agonist, has shown its efficiency in the treatment of delirium in intubated patients but also in its prevention. Dexmedetomidine represents a widely used alternative to haloperidol. Only few studies have compared the efficacy of dexmedetomidine in non-intubated ICU patients as a first-line curative treatment of delirium. The main objective of the 4D trial is to demonstrate that dexmedetomidine decreases delirium duration compared to placebo. METHODS/DESIGN: The 4D trial is an investigator-initiated, prospective, multicenter, randomized, double-blinded, two-arm trial, randomizing 300 non-intubated ICU patients with a diagnosis of agitated delirium to receive dexmedetomidine or placebo as a cure. In case of agitation (RASS≥ + 2), immediate haloperidol administration will be allowed, to protect patient and staff in charge, while waiting for study treatment action. The primary outcome measure is a composite of duration of agitation or delirium or the use of intubation with deep sedation and mechanical ventilation. Secondary outcomes include mortalities at 7 and 30 days, ICU length of stay and occurrence of adverse effects related to dexmedetomidine use (bradycardia or hypotension requesting any treatment; or haloperidol use (neuroleptic malignant syndrome, extrapyramidal syndrome, prolonged QTc). The sample size will allow the detection of a 50% decrease of agitation duration (120 min), of an absolute reduction of delirium duration (1 day) and of a 50% relative decrease of intubation and mechanical ventilation, with a type 1 error rate of 1.8% (error risk inflation due to components of composite) and power of 90%, assuming a 15% incidence of intubation and mechanical ventilation requirements, an agitation duration of 240 min and a delirium duration of 3 days. One hundred and ten patients by group will be needed. An intermediate analysis is scheduled and requires the inclusion of 150 patients. DISCUSSION: The 4D trial may provide important data on the safety of commonly used sedative dexmedetomidine and could have a significant impact on future treatment of non-intubated ICU patients presenting with agitated delirium. TRIAL REGISTRATION: ClinicalTrials.gov , ID: NCT 03317067 . Registered on 23 October 2017.


Assuntos
Delírio/tratamento farmacológico , Dexmedetomidina/uso terapêutico , Hipnóticos e Sedativos/uso terapêutico , Unidades de Terapia Intensiva , Delírio/diagnóstico , Delírio/psicologia , Dexmedetomidina/efeitos adversos , Método Duplo-Cego , França , Humanos , Hipnóticos e Sedativos/efeitos adversos , Estudos Multicêntricos como Assunto , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo , Resultado do Tratamento
15.
Presse Med ; 47(5): 453-463, 2018 May.
Artigo em Francês | MEDLINE | ID: mdl-29609909

RESUMO

Obesity is often associated with obstructive sleep apnea (OSA), which increases the risk of intraoperative and postoperative complications. The role of preoperative screening of OSA is crucial, with adequate management based on continuous positive pressure before, during and after surgery. The obese patient is at risk of postoperative complications: difficult airway management, acute respiratory failure following extubation due to atelectasis and airway obstruction, added to morphine overdosing. Optimal management of difficult mask ventilation and intubation, protective ventilation, combined to the reduction of sedatives and analgesics and the sitting position as soon as possible with a postoperative monitoring should decrease the occurrence of complications. Cardiovascular risk is also increased in the obese patient. Preoperative screening of cardiovascular complications with appropriate therapy, combined to per- and postoperative hemodynamic optimization with a close monitoring allow to limit the cardiovascular risk. Drug dosing titration is fundamental due to unknown pharmacokinetic and pharmacodynamics properties in obese patients. Neuromuscular monitoring should always be used whenever neuromuscular blocking drugs are used, as depth of anaesthesia monitoring, especially when total intravenous anaesthesia is used in conjunction with neuromuscular blocking drugs. Appropriate prophylaxis against venous thromboembolism (VTE) after assessment of risk benefit ratio and early mobilisation are recommended since the incidence of venous thromboembolism is increased in the obese.


Assuntos
Anestésicos/efeitos adversos , Cirurgia Bariátrica/efeitos adversos , Obesidade Mórbida/cirurgia , Complicações Pós-Operatórias/etiologia , Anestesia Geral/efeitos adversos , Anestésicos/farmacocinética , Cirurgia Bariátrica/métodos , Humanos , Doença Iatrogênica , Obesidade Mórbida/epidemiologia , Obesidade Mórbida/metabolismo , Complicações Pós-Operatórias/epidemiologia , Fatores de Risco
16.
Crit Care Med ; 46(4): e294-e301, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29293153

RESUMO

OBJECTIVES: To determine the short- and long-term mortality of obese ICU patients following medical as opposed to surgical admission and the relation between obesity and mortality. DESIGN: Retrospective analysis of prospectively collected data, using a propensity score-matched analysis of patients with medical or surgical admission. SETTING: One French mixed medical-surgical ICU. PATIENTS: Critically ill obese patients (body mass index ≥ 30 kg/m) and nonobese patients admitted during a 14-year period. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Seven-hundred ninety-one obese patients and 4,644 nonobese patients were included, 338 (43%) and 2,367 (51%) medical and 453 (57%) and 2,277 (49%) surgical obese and nonobese patients, respectively. Mortality was significantly higher in medical than in surgical obese patients in ICU (25% vs 12%; p < 0.001) and up to 365 days (36% vs 18%; p < 0.001) post ICU admission. One-to-one propensity score matching generated 260 pairs with well-balanced baseline characteristics. After matching on propensity score, mortality was still significantly higher in medical patients both in the ICU (21% vs 13%; p = 0.03) and up to 365 days (30% vs 20%; p = 0.01) post ICU admission. Obesity was not significantly associated with mortality both in univariate analysis (140 obese patients [15%] in the dead group vs 651 [14%] in the alive group; p = 0.72) and multivariate analysis (odds ratio, 1.09 [95% CI, 0.86-1.38]; p = 0.49) after adjustment for Simplified Acute Physiology Score II, age, category of admission, history of cardiac disease, and history of respiratory disease. CONCLUSIONS: After careful matching, the data suggest that ICU mortality in obese population was higher in the medical group than in the surgical group and remains significantly higher 365 days post ICU admission.


Assuntos
Índice de Massa Corporal , Unidades de Terapia Intensiva/classificação , Unidades de Terapia Intensiva/estatística & dados numéricos , Obesidade/mortalidade , APACHE , Adulto , Idoso , Feminino , França , Mortalidade Hospitalar/tendências , Humanos , Estimativa de Kaplan-Meier , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Procedimentos Cirúrgicos Operatórios/mortalidade
17.
Lancet Respir Med ; 5(10): 795-805, 2017 10.
Artigo em Inglês | MEDLINE | ID: mdl-28935558

RESUMO

BACKGROUND: Avoidance of excessive sedation and subsequent prolonged mechanical ventilation in intensive care units (ICUs) is recommended, but no data are available for critically ill postoperative patients. We hypothesised that in such patients stopping sedation immediately after admission to the ICU could reduce unnecessary sedation and improve patient outcomes. METHODS: We did a randomised, parallel-group, clinical trial at three ICUs in France. Stratified randomisation with minimisation (1:1 via a restricted web platform) was used to assign eligible patients (aged ≥18 years, admitted to an ICU after abdominal surgery, and expected to require at least 12 h of mechanical ventilation because of a critical illness defined by a Sequential Organ Failure Assessment score >1 for any organ, but without severe acute respiratory distress syndrome or brain injury) to usual sedation care provided according to recommended practices (control group) or to immediate interruption of sedation (intervention group). The primary outcome was the time to successful extubation (defined as the time from randomisation to the time of extubation [or tracheotomy mask] for at least 48 h). All patients who underwent randomisation (except for those who were excluded after randomisation) were included in the intention-to-treat analysis. This study is registered with ClinicalTrials.gov, number NCT01486121. FINDINGS: Between Dec 2, 2011, and Feb 27, 2014, 137 patients were randomly assigned to the control (n=68) or intervention groups (n=69). In the intention-to-treat analysis, time to successful extubation was significantly lower in the intervention group than in the control group (median 8 h [IQR 4-36] vs 50 h [29-93], group difference -33·6 h [95% CI -44·9 to -22·4]; p<0·0001). The adjusted hazard ratio was 5·2 (95% CI 3·1-8·8, p<0·0001). INTERPRETATION: Immediate interruption of sedation in critically ill postoperative patients with organ dysfunction who were admitted to the ICU after abdominal surgery improved outcomes compared with usual sedation care. These findings support interruption of sedation in these patients following transfer from the operating room. FUNDING: Délégation à la Recherche Clinique et à l'Innovation du Groupement de Coopération Sanitaire de la Mission d'Enseignement, de Recherche, de Référence et d'Innovation (DRCI-GCS-MERRI) de Montpellier-Nîmes.


Assuntos
Sedação Consciente/métodos , Cuidados Críticos/métodos , Hipnóticos e Sedativos/administração & dosagem , Cuidados Pós-Operatórios/métodos , Respiração Artificial/métodos , Idoso , Estado Terminal/terapia , Esquema de Medicação , Feminino , Humanos , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Fatores de Tempo
18.
Intensive Care Med ; 42(12): 1888-1898, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27771739

RESUMO

PURPOSE: High-flow nasal cannula (HFNC) oxygen therapy is attracting increasing interest in acute medicine as an alternative to standard oxygen therapy; however, its use to prevent hypoxaemia after major abdominal surgery has not been evaluated. Our trial was designed to close this evidence gap. METHODS: A multicentre randomised controlled trial was carried out at three university hospitals in France. Adult patients at moderate to high risk of postoperative pulmonary complications who had undergone major abdominal surgery using lung-protective ventilation were randomly assigned using a computer-generated sequence to receive either HFNC oxygen therapy or standard oxygen therapy (low-flow oxygen delivered via nasal prongs or facemask) directly after extubation. The primary endpoint was absolute risk reduction (ARR) for hypoxaemia at 1 h after extubation and after treatment discontinuation. Secondary outcomes included occurrence of postoperative pulmonary complications within 7 days after surgery, the duration of hospital stay, and in-hospital mortality. The analysis was performed on data from the modified intention-to-treat population. This trial was registered with ClinicalTrials.gov (NCT01887015). RESULTS: Between 6 November 2013 and 1 March 2015, 220 patients were randomly assigned to receive either HFNC (n = 108) or standard oxygen therapy (n = 112); all of these patients completed follow-up. The median duration of the allocated treatment was 16 h (interquartile range 14-18 h) with standard oxygen therapy and 15 h (interquartile range 12-18) with HFNC therapy. Twenty-three (21 %) of the 108 patients treated with HFNC 1 h after extubation and 29 (27 %) of the 108 patients after treatment discontinuation had postextubation hypoxaemia, compared with 27 (24 %) and 34 (30 %) of the 112 patients treated with standard oxygen (ARR 4, 95 % CI -8 to 15 %; p = 0.57; adjusted relative risk [RR] 0.87, 95 % CI 0.53-1.43; p = 0.58). Over the 7-day postoperative follow-up period, there was no statistically significant difference between the groups in the proportion of patients who remained free of any pulmonary complication (ARR 7, 95 % CI -6 to 20 %; p = 0.40). Other secondary outcomes also did not differ significantly between the two groups. CONCLUSIONS: Among patients undergoing major abdominal surgery, early preventive application of high-flow nasal cannula oxygen therapy after extubation did not result in improved pulmonary outcomes compared with standard oxygen therapy.


Assuntos
Abdome/cirurgia , Extubação/efeitos adversos , Hipóxia/prevenção & controle , Oxigenoterapia/métodos , Complicações Pós-Operatórias/prevenção & controle , Respiração Artificial/métodos , Idoso , Feminino , França , Mortalidade Hospitalar , Humanos , Hipóxia/etiologia , Análise de Intenção de Tratamento , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Período Pós-Operatório , Fatores de Tempo , Desmame do Respirador
19.
Liver Transpl ; 22(7): 906-13, 2016 07.
Artigo em Inglês | MEDLINE | ID: mdl-27149437

RESUMO

Recipient hepatectomy is a challenging liver transplantation (LT) procedure that has life-threatening complications. The current predictive mortality clinic-biological scores (Child/Model for End-Stage Liver Disease [MELD]) do not take into consideration the recipient's liver anatomy. The aim of this study was to evaluate the impact of the dorsal sector anatomy of a cirrhotic liver on the morbidity/mortality rates of hepatectomy. A multicenter retrospective study (clinic-biological and morphologic) was performed from 2013 to 2014. The degree of encirclement of the inferior vena cava (IVC) by the dorsal sector of the liver was measured. The study population included 320 patients. Seventy-four (23%) patients had complete IVC encirclement. A correlation (P = 0.01) has been reported between the existence of a circular dorsal sector and the number of transfusions during LT (4 packed red blood cell [PRBC] transfusions in the group without IVC versus 7 PRBC transfusions in the other group). The existence of such anatomy increases the relative risk of early reoperation for IVC bleeding by 31% (P = 0.05). There is a correlation between alcoholic cirrhosis and dorsal-sector hypertrophy (126 cc versus 147.5 cc; P = 0.05). Concerning surgical time, we found no significant between-group differences. Compared to the severity of cirrhosis, an inverse correlation was observed between the MELD and Child scores and the dorsal sector hypertrophy (P < 0.001). No significant difference in terms of transfusion was found between the temporary portocaval shunt group (n = 168) and the other group (n = 152). The presence of a circular sector is associated with an increased risk of hemorrhage during hepatectomy, as well as an immediate postoperative risk of reoperation. Liver Transplantation 22 906-913 2016 AASLD.


Assuntos
Doença Hepática Terminal/cirurgia , Hepatectomia/efeitos adversos , Cirrose Hepática/cirurgia , Transplante de Fígado/efeitos adversos , Fígado/patologia , Veia Cava Inferior/patologia , Perda Sanguínea Cirúrgica/estatística & dados numéricos , Transfusão de Sangue/estatística & dados numéricos , Doença Hepática Terminal/diagnóstico por imagem , Doença Hepática Terminal/etiologia , Feminino , Hepatectomia/mortalidade , Humanos , Hipertrofia/complicações , Fígado/diagnóstico por imagem , Cirrose Hepática/complicações , Cirrose Hepática/diagnóstico por imagem , Cirrose Hepática Alcoólica/complicações , Cirrose Hepática Alcoólica/diagnóstico por imagem , Cirrose Hepática Alcoólica/cirurgia , Transplante de Fígado/mortalidade , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Derivação Portocava Cirúrgica , Veia Porta/cirurgia , Reoperação/estatística & dados numéricos , Estudos Retrospectivos , Índice de Gravidade de Doença , Tomografia Computadorizada por Raios X , Veia Cava Inferior/cirurgia
20.
JAMA ; 315(13): 1345-53, 2016 Apr 05.
Artigo em Inglês | MEDLINE | ID: mdl-26975890

RESUMO

IMPORTANCE: It has not been established whether noninvasive ventilation (NIV) reduces the need for invasive mechanical ventilation in patients who develop hypoxemic acute respiratory failure after abdominal surgery. OBJECTIVE: To evaluate whether noninvasive ventilation improves outcomes among patients developing hypoxemic acute respiratory failure after abdominal surgery. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, randomized, parallel-group clinical trial conducted between May 2013 and September 2014 in 20 French intensive care units among 293 patients who had undergone abdominal surgery and developed hypoxemic respiratory failure (partial oxygen pressure <60 mm Hg or oxygen saturation [SpO2] ≤90% when breathing room air or <80 mm Hg when breathing 15 L/min of oxygen, plus either [1] a respiratory rate above 30/min or [2] clinical signs suggestive of intense respiratory muscle work and/or labored breathing) if it occurred within 7 days after surgical procedure. INTERVENTIONS: Patients were randomly assigned to receive standard oxygen therapy (up to 15 L/min to maintain SpO2 of 94% or higher) (n = 145) or NIV delivered via facial mask (inspiratory pressure support level, 5-15 cm H2O; positive end-expiratory pressure, 5-10 cm H2O; fraction of inspired oxygen titrated to maintain SpO2 ≥94%) (n = 148). MAIN OUTCOMES AND MEASURES: The primary outcome was tracheal reintubation for any cause within 7 days of randomization. Secondary outcomes were gas exchange, invasive ventilation-free days at day 30, health care-associated infections, and 90-day mortality. RESULTS: Among the 293 patients (mean age, 63.4 [SD, 13.8] years; n=224 men) included in the intention-to-treat analysis, reintubation occurred in 49 of 148 (33.1%) in the NIV group and in 66 of 145 (45.5%) in the standard oxygen therapy group within+ 7 days after randomization (absolute difference, -12.4%; 95% CI, -23.5% to -1.3%; P = .03). Noninvasive ventilation was associated with significantly more invasive ventilation-free days compared with standard oxygen therapy (25.4 vs 23.2 days; absolute difference, -2.2 days; 95% CI, -0.1 to 4.6 days; P = .04), while fewer patients developed health care-associated infections (43/137 [31.4%] vs 63/128 [49.2%]; absolute difference, -17.8%; 95% CI, -30.2% to -5.4%; P = .003). At 90 days, 22 of 148 patients (14.9%) in the NIV group and 31 of 144 (21.5%) in the standard oxygen therapy group had died (absolute difference, -6.5%; 95% CI, -16.0% to 3.0%; P = .15). There were no significant differences in gas exchange. CONCLUSIONS AND RELEVANCE: Among patients with hypoxemic respiratory failure following abdominal surgery, use of NIV compared with standard oxygen therapy reduced the risk of tracheal reintubation within 7 days. These findings support use of NIV in this setting. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01971892.


Assuntos
Procedimentos Cirúrgicos do Sistema Digestório/efeitos adversos , Hipóxia/terapia , Intubação Intratraqueal/estatística & dados numéricos , Ventilação não Invasiva/estatística & dados numéricos , Oxigenoterapia/estatística & dados numéricos , Complicações Pós-Operatórias/terapia , Insuficiência Respiratória/terapia , Infecção Hospitalar/epidemiologia , Feminino , Humanos , Hipóxia/etiologia , Unidades de Terapia Intensiva , Análise de Intenção de Tratamento , Intubação Intratraqueal/mortalidade , Masculino , Pessoa de Meia-Idade , Ventilação não Invasiva/efeitos adversos , Ventilação não Invasiva/mortalidade , Oxigenoterapia/efeitos adversos , Oxigenoterapia/métodos , Oxigenoterapia/mortalidade , Respiração com Pressão Positiva , Troca Gasosa Pulmonar , Insuficiência Respiratória/etiologia , Insuficiência Respiratória/mortalidade , Retratamento/estatística & dados numéricos , Fatores de Tempo
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