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1.
BMC Med Educ ; 24(1): 351, 2024 Mar 29.
Artigo em Inglês | MEDLINE | ID: mdl-38553674

RESUMO

BACKGROUND: Simulation-based training is effective for ultrasound (US)-guided procedures. However, commercially developed simulators are costly. This study aims to evaluate the feasibility of a hand-made phantom for US-guided paracentesis. METHODS: We described the recipe to prepare an agar phantom. We collected the US performance data of 50 novices, including 22 postgraduate-year (PGY) residents and 28 undergraduate-year (UGY) students, who used the phantom for training, as well as 12 emergency residents with prior US-guided experience. We obtained the feedback after using the phantom with the Likert 5-point scale. The data were presented with medians and interquartile ranges (IQRs) and analyzed by the Wilcoxon rank sum test. RESULTS: While emergency residents demonstrated superior performance compared to trainees, all trainees exhibited acceptable proficiency (global rating of ≥ 3, 50/50 vs. 12/12, p = 1.000) and comparable needle steadiness [5 (5) vs. 5 (5), p = 0.223]. No significant difference in performance was observed between PGYs [5 (4-5)] and UGYs [5 (4-5), p = 0.825]. No significant differences were observed in terms of image stimulation, puncture texture, needle visualization, drainage simulation, and endurance of the phantom between emergency residents and trainees. However, experienced residents rated puncture texture and draining fluid as "neutral" (3/5 on the Likert scale). The cost of the paracentesis phantom is US$16.00 for at least 30 simulations, reducing it to US$6.00 without a container. CONCLUSIONS: The paracentesis phantom proves to be a practical and cost-effective training tool. It enables novices to acquire paracentesis skills, enhances their US proficiency, and boosts their confidence. Nevertheless, further investigation is needed to assess its long-term impact on clinical performance in real patients. TRIAL REGISTRATION: NCT04792203 at the ClinicalTrials.gov.


Assuntos
Paracentese , Ultrassonografia de Intervenção , Humanos , Paracentese/educação , Estudos de Viabilidade , Ultrassonografia/métodos , Imagens de Fantasmas , Ultrassonografia de Intervenção/métodos , Competência Clínica
2.
BMC Surg ; 24(1): 86, 2024 Mar 12.
Artigo em Inglês | MEDLINE | ID: mdl-38475783

RESUMO

OBJECTIVE: To compare neuronavigation-assisted intracerebral hematoma puncture and drainage with neuroendoscopic hematoma removal for treatment of hypertensive cerebral hemorrhage. METHOD: Ninety-one patients with hypertensive cerebral hemorrhage admitted to our neurosurgery department from June 2022 to May 2023 were selected: 47 patients who underwent endoscopic hematoma removal with the aid of neuronavigation in observation Group A and 44 who underwent intracerebral hematoma puncture and drainage in control Group B. The duration of surgery, intraoperative bleeding, hematoma clearance rate, pre- and postoperative GCS score, National Institutes of Health Stroke Scale (NIHSS) score, mRS score and postoperative complications were compared between the two groups. RESULTS: The duration of surgery, intraoperative bleeding and hematoma clearance were significantly lower in Group B than in Group A (p < 0.05). Conversely, no significant differences in the preoperative, 7-day postoperative, 14-day postoperative or 1-month postoperative GCS or NIHSS scores or the posthealing mRS score were observed between Groups A and B. However, the incidence of postoperative complications was significantly greater in Group B than in Group A (p < 0.05), with the most significant difference in incidence of intracranial infection (p < 0.05). CONCLUSION: Both neuronavigation-assisted intracerebral hematoma puncture and drainage and neuroendoscopic hematoma removal are effective at improving the outcome of patients with hypertensive cerebral hemorrhage. The disadvantage of neuronavigation is that the incidence of complications is significantly greater than that of other methods; postoperative care and prevention of complications should be strengthened in clinical practice.


Assuntos
Hemorragia Intracraniana Hipertensiva , Neuroendoscopia , Humanos , Neuronavegação/métodos , Hemorragia Intracraniana Hipertensiva/cirurgia , Paracentese , Resultado do Tratamento , Drenagem/métodos , Neuroendoscopia/métodos , Hematoma/cirurgia , Complicações Pós-Operatórias/cirurgia , Estudos Retrospectivos
4.
Sci Rep ; 14(1): 5307, 2024 03 04.
Artigo em Inglês | MEDLINE | ID: mdl-38438438

RESUMO

This study introduces PDMotion, a mobile application comprising 11 digital tests, including those adapted from the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III and novel assessments, for remote Parkinson's Disease (PD) motor symptoms evaluation. Employing machine learning techniques on data from 50 PD patients and 29 healthy controls, PDMotion achieves accuracies of 0.878 for PD status prediction and 0.715 for severity assessment. A post-hoc explanation model is employed to assess the importance of features and tasks in diagnosis and severity evaluation. Notably, novel tasks that are not adapted from MDS-UPDRS Part III like the circle drawing, coordination test, and alternative tapping test are found to be highly important, suggesting digital assessments for PD can go beyond digitizing existing tests. The alternative tapping test emerges as the most significant task. Using its features alone achieves prediction accuracies comparable to the full task set, underscoring its potential as an independent screening tool. This study addresses a notable research gap by digitalizing a wide array of tests, including novel ones, and conducting a comparative analysis of their feature and task importance. These insights provide guidance for task selection and future development in PD mobile assessments, a field previously lacking such comparative studies.


Assuntos
Aplicativos Móveis , Doença de Parkinson , Humanos , Doença de Parkinson/diagnóstico , Aprendizado de Máquina , Testes de Estado Mental e Demência , Paracentese
5.
J Vet Intern Med ; 38(2): 1232-1239, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38407387

RESUMO

BACKGROUND: Iatrogenic blood contamination during cerebrospinal fluid (CSF) centesis is common, which can limit the diagnostic usefulness of the sample. A novel ultrasound-guided CSF collection technique is described in horses, by which CSF is obtained from the atlantoaxial (AA) space. HYPOTHESIS/OBJECTIVES: To compare ultrasound-guided AA centesis with lumbosacral (LS) centesis in South American camelids (SAC). The hypotheses were that AA centesis would yield samples with less blood contamination although being technically more challenging than LS centesis. ANIMALS: Eight clinically healthy adult SAC from a university-owned teaching herd. METHODS: Single-blinded, randomized, 4-way, 4-period crossover study in which 2 veterinarians each performed both centesis techniques on each animal once. Cytological sample analysis was performed, and the technical difficulty of sample acquisition was assessed. RESULTS: The CSF was collected successfully and without complications by either technique during all collection attempts. Aspects of technical difficulty and concentrations of CSF analytes did not vary significantly between techniques. Median total nucleated cell and red blood cell counts were 1/µL and 0.5/µL and 167.5/µL and 155/µL for AA and LS techniques, respectively. The median total protein concentration was 32.9 mg/dL and 38 mg/dL for AA and LS centeses. A median of 1 attempt was necessary for both centesis techniques and the median number of needle repositioning events was 1 for AA and 0 for LS. CONCLUSION AND CLINICAL IMPORTANCE: Depending on clinical circumstances, ultrasound-guided AA centesis appears to be an acceptable alternative to other techniques for collection of CSF from SAC.


Assuntos
Líquido Cefalorraquidiano , Paracentese , Humanos , Cavalos , Animais , Paracentese/veterinária , Estudos Cross-Over , Ultrassonografia , Contagem de Eritrócitos/veterinária , América do Sul
6.
BMJ Open ; 14(1): e076434, 2024 01 22.
Artigo em Inglês | MEDLINE | ID: mdl-38262643

RESUMO

INTRODUCTION: Ovarian hyperstimulation syndrome (OHSS) is the most significant short-term complication of pharmacological ovarian stimulation. Symptoms range from mild abdominal discomfort to rare complications such as renal failure, thromboembolism and respiratory distress syndrome.Currently, clinical practice typically involves monitoring the patient until the condition becomes severe, at which point they are admitted to hospital, where drainage of ascitic fluid (paracentesis) may take place. Preliminary studies have indicated that earlier outpatient paracentesis may reduce the progression of OHSS and prevent hospitalisation in women. METHODS AND ANALYSIS: This UK, multicentre, pragmatic, two-arm, parallel-group, adaptive (group sequential with one interim analysis), open-label, superiority, confirmatory, group sequential, individually randomised controlled trial, with internal pilot will assess the clinical and cost-effectiveness and safety of outpatient paracentesis versus conservative management (usual care) for moderate or severe OHSS. 224 women from 20 National Health Service and private fertility units will be randomised (1:1) and followed up for up to 13.5 months. The primary outcome is the rate of OHSS related hospital admission of at least 24 hours within 28 days postrandomisation. The primary analysis will be an intention to treat with difference in hospitalisation rates as measure of treatment effect. Secondary outcomes include time to resolution of symptoms, patient satisfaction, adverse events and cost-effectiveness. A qualitative substudy will facilitate the feasibility of recruitment. Participant recruitment commenced in June 2022. ETHICS AND DISSEMINATION: London-Southeast Research Ethics Committee approved the protocol (reference: 22/LO/0015). Findings will be submitted to peer-reviewed journals and abstracts to relevant national and international conferences, as well as being disseminated to trial participants and patient groups. TRIAL REGISTRATION NUMBER: ISRCTN71978064.


Assuntos
Pacientes Ambulatoriais , Síndrome de Hiperestimulação Ovariana , Feminino , Humanos , Drenagem , Estudos Multicêntricos como Assunto , Paracentese , Ensaios Clínicos Controlados Aleatórios como Assunto , Medicina Estatal , Ensaios Clínicos Pragmáticos como Assunto
8.
Dig Dis Sci ; 69(4): 1454-1466, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38217676

RESUMO

Spontaneous bacterial peritonitis (SBP) is the most common infection in patients with cirrhosis and is associated with high mortality. Although recent literature reports mortality benefits to early diagnostic paracentesis, current guidelines do not offer specific recommendations for how quickly diagnostic paracentesis should be performed in patients with cirrhosis and ascites who are admitted to the hospital. Therefore, we conducted a systematic review and meta-analysis to evaluate outcomes among patients admitted to the hospital with cirrhosis and ascites receiving paracentesis within ≤ 12, ≤ 1 day, and > 1 day. Eight studies with 116,174 patients were included in the final meta-analysis. The pooled risk of in-hospital mortality was significantly lower in patients who underwent early (≤ 12 h or ≤ 1 day) compared to delayed (> 12 h or > 1 day) paracentesis (RR: 0.69, p < 0.00001), and in patients who underwent paracentesis compared to no paracentesis (RR: 0.74, p < 0.00001). On subgroup analysis, in-hospital mortality was significantly lower in both paracentesis within ≤ 12 h (RR: 0.61, p = 0.02) vs. > 12 h, and within ≤ 1 day (RR: 0.70, p < 0.00001) vs. > 1 day. While there was a trend towards decreased mortality in those undergoing paracentesis within ≤ 12 h compared to ≤ 1 day, the difference did not reach statistical significance. The length of hospital stay was significantly shorter by 5.38 days in patients who underwent early (≤ 12 h) compared to delayed (> 12 h) paracentesis (95% CI 4.24-6.52, p < 0.00001). Early paracentesis is associated with reduced mortality and length of hospital stay. We encourage providers to perform diagnostic paracentesis in a timely manner, at least within 1 day of hospital admission, for all patients with cirrhosis and ascites.


Assuntos
Infecções Bacterianas , Peritonite , Humanos , Tempo de Internação , Ascite , Paracentese , Cirrose Hepática/complicações , Hospitalização , Peritonite/microbiologia , Infecções Bacterianas/complicações
9.
J Pain Symptom Manage ; 67(3): e163-e168, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-37992847

RESUMO

CONTEXT: The symptoms associated with the excessive fluid accumulation of ascites or pleural effusions can be intractable to medical management and can have a significant negative impact on quality of life of hospice patients. Hospice of the Valley, a community-based, nonprofit hospice agency has historically referred patients to outpatient providers for paracentesis, thoracentesis, and placement of tunneled drainage catheters. OBJECTIVES: To describe an in-house pilot program of tunneled catheter placement to provide immediate and longer-term symptom relief for selected hospice patients. METHODS: The logistics and cost of the pilot program are described. Key data elements, including select demographics, patient eligibility screening, and incidence of procedure-related or late complications are reported. RESULTS: A total of 135 drainage procedures completed on 127 unique hospice patients over 27 months (2020-2023) were reviewed. The rate of procedure-related complications (<4%) and late complications (<3%) are low. The average cost per procedure ($1030) compares favorably with outpatient providers' fees. The program was well-accepted by the interdisciplinary hospice team, patients, and families. CONCLUSIONS: An in-house program of tunneled catheter placement is a feasible option for hospice providers with low-cost exposure and high potential for improved quality of life and symptom relief for selected patients.


Assuntos
Hospitais para Doentes Terminais , Humanos , Qualidade de Vida , Paracentese/métodos , Drenagem/métodos , Cateteres
10.
J Ocul Pharmacol Ther ; 40(1): 100-107, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-37851489

RESUMO

Background/Aims: The current standard of care to perform an anterior chamber paracentesis involves the use of a multipurpose market needle and syringe. The use of standard needles for this purpose may result in injury to the patient due to increased force with insertion and increased globe displacement during the procedure. This research investigates the current market needle characteristics and the impact of each needle characteristic on force. Methods: Several comparative trials were conducted to evaluate the needles. Needle characteristics of interest were gauge, primary bevel angle, number of bevels in the lancet, and needle hub geometry. Measurements of corneal insertion forces were made using a synthetic thermoplastic polyurethane medium, and bovine and porcine models. Needle safety was investigated with corneal abrasion experiments. Results: Reduced insertion force was observed with lower lancet primary angle. There was no difference based on the number of bevels in the lancet. Rounded hub geometry had minimal distribution to the corneal epithelium. Conclusions: Needle characteristics impact the force needed for needle insertion into the tissue. Since higher force can lead to increased risk and less efficiency during the procedure, reducing this force may improve the outcomes of the procedure. Needle entry can be reduced by designing an improved needle that includes a lower gauge and reduced primary angle of the lancet.


Assuntos
Agulhas , Paracentese , Animais , Bovinos , Humanos , Suínos , Paracentese/efeitos adversos , Modelos Animais , Câmara Anterior/cirurgia
12.
Indian J Pediatr ; 91(3): 270-279, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-37310583

RESUMO

Development of ascites in children with chronic liver disease is the most common form of decompensation. It is associated with a poor prognosis and increased risk of mortality. A diagnostic paracentesis should be performed in liver disease patients with- new-onset ascites, at the beginning of each hospital admission and when ascitic fluid infection (AFI) is suspected. The routine analysis includes cell count with differential, bacterial culture, ascitic fluid total protein and albumin. A serum albumin-ascitic fluid albumin gradient of ≥1.1 g/dL confirms the diagnosis of portal hypertension. Ascites has been reported in children with non-cirrhotic liver disease like acute viral hepatitis, acute liver failure and extrahepatic portal venous obstruction. The main steps in management of cirrhotic ascites include dietary sodium restriction, diuretics and large-volume paracentesis. Sodium should be restricted to maximum of 2 mEq/kg/d (max 90 mEq/d) of sodium/day. Oral diuretic therapy comprises of aldosterone antagonists (e.g., spironolactone) with or without loop-diuretics (e.g., furosemide). Once the ascites is mobilized, the diuretics should be gradually tapered to the minimum effective dosage. Tense ascites should be managed with a large-volume paracentesis (LVP) preferably with albumin infusion. Therapeutic options for refractory ascites include recurrent LVP, transjugular intrahepatic porto-systemic shunt and liver transplantation. AFI (fluid neutrophil count ≥250/mm3) is an important complication, and requires prompt antibiotic therapy. Hyponatremia, acute kidney injury, hepatic hydrothorax and hernias are the other complications.


Assuntos
Hipertensão Portal , Peritonite , Criança , Humanos , Ascite/diagnóstico , Ascite/etiologia , Ascite/terapia , Peritonite/diagnóstico , Diuréticos/uso terapêutico , Paracentese/efeitos adversos , Hipertensão Portal/complicações , Albumina Sérica , Sódio , Cirrose Hepática/complicações
13.
Clin Imaging ; 105: 110033, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38042055

RESUMO

RATIONALE AND OBJECTIVES: To meet the increasing demand for radiology departments to perform paracenteses, this study was done to compare the operational, financial and clinical impact of draining ascites with a peristaltic pump versus conventional vacuum containers. MATERIALS & METHODS: Prospective cohort study of 157 paracenteses (56 subjects) drained with ACCEL® evacuated drainage bottles (B. Braun Interventional Systems, Bethlehem, PA) and 159 paracenteses (53 subjects) drained with the RenovaRP® pump (Laborie Medical Technologies Corp., Portsmouth, NH). A short elective questionnaire was then distributed to the procedure staff and the subjects drained by both methods. RESULTS: Mean volume drained with the pump (5 L) was comparable to that drained by vacuum containers (4.9 L, p = 0.77). Mean time to drain subjects with the pump (18.6 min) was 9.1 min shorter and 3.8 min less variable than subjects drained with vacuum containers (27.7 min). This difference was statistically significant (p < 0.01) and clinically important (effect size = 0.73). Flow rate with the pump (4 min/L) was significantly faster (p < 0.05) than vacuum containers flow rate (6.6 min/L). No adverse events occurred in either group. Use of the pump increased the average cost by 21% and reduced earnings by 3%. All assistants (n = 6) and patients (n = 10) that responded to the questionnaire recommended the use of the pump over vacuum containers. CONCLUSION: The peristaltic pump safely drains ascites significantly faster and with less variability in time than vacuum containers. While use of the pump slightly increases cost per paracentesis, it was recommended by all paired subjects undergoing a paracentesis and all personnel assisting in the procedure.


Assuntos
Ascite , Paracentese , Humanos , Paracentese/efeitos adversos , Ascite/etiologia , Ascite/terapia , Vácuo , Estudos Prospectivos , Drenagem
15.
BMC Surg ; 23(1): 363, 2023 Nov 27.
Artigo em Inglês | MEDLINE | ID: mdl-38012699

RESUMO

BACKGROUND: We sought to evaluate the effect of early short-term abdominal paracentesis drainage (APD) in moderately severe and severe acute pancreatitis (MSAP/SAP) with pelvic ascites. METHODS: A total of 135 MSAP/SAP patients with early pelvic ascites were divided into the Short-term APD group (57 patients) and the Non-APD group (78 patients). The effects, complications, and prognosis of short-term APD patients were evaluated. RESULTS: The baseline characteristics in the two groups were similar. The target days of intra-abdominal hypertension relief, half-dose enteral nutrition, duration of mechanical ventilation, length of intensive care unit stay (in days) and total hospitalization (also in days) were all lower in the Short-term APD group than in the Non-APD group (P = 0.002, 0.009, 0.004, 0.006 and 0.019), while the white blood cell count and serum C-reaction protein level decreased significantly more quickly (P < 0.01 and P < 0.05), and the prevalence of intra-abdominal infection was also significantly lower (P = 0.014) in the former than the latter. No complications occurred in early APD patients, and the microbial cultures of pelvic ascites were all negative. In addition, patients with early APD presented fewer cases of residual wall-off necrosis or fluid collection (P = 0.008) at discharge and had a lower incidence of rehospitalization and percutaneous catheter drainage and/or necrosectomy (P = 0.017 and 0.009). CONCLUSIONS: For MSAP/SAP patients with pelvic ascites, the early short-term APD is feasible and safe to perform, and it can decrease clinical symptoms, reduce intra-abdominal infection and shorten the hospital stay. It may also reduce the incidence of rehospitalization and surgical intervention.


Assuntos
Infecções Intra-Abdominais , Pancreatite , Humanos , Pancreatite/complicações , Pancreatite/terapia , Paracentese , Ascite/etiologia , Ascite/cirurgia , Doença Aguda , Drenagem/efeitos adversos , Infecções Intra-Abdominais/complicações
17.
Radiologia (Engl Ed) ; 65 Suppl 2: S33-S40, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37858351

RESUMO

OBJECTIVE: Calcific tendinopathy of the rotator cuff is a common condition caused by the deposition of calcium crystals in the tendons of the rotator cuff. This study aimed to analyze the effectiveness of ultrasound-guided puncture and aspiration in calcific tendinopathy of the should in 86 patients treated at our center and to determine the factors associated with poor prognosis after this treatment. MATERIAL AND METHODS: This retrospective descriptive study included 86 patients with calcific tendinopathy of the rotator cuff treated with ultrasound-guided puncture and aspiration between 2015 and 2019 for whom clinical and radiological variables were collected 1, 3, 6, and 12 months after the procedure. RESULTS: One year after treatment, 81.4% patients showed clinical improvement and 96.5% showed radiological improvement. Complications were observed in 34.9%; all complications were mild. CONCLUSIONS: Ultrasound-guided puncture and aspiration is an effective treatment for calcific tendinopathy of the shoulder, resulting in a high rate of clinical and radiological improvement and a low rate of minor complications. This technique has additional advantages, such as interaction with the patient and the lack of ionizing radiation.


Assuntos
Doenças Musculoesqueléticas , Tendinopatia , Humanos , Manguito Rotador/diagnóstico por imagem , Estudos Retrospectivos , Paracentese/efeitos adversos , Ultrassonografia de Intervenção/métodos , Tendinopatia/diagnóstico por imagem , Tendinopatia/terapia , Tendinopatia/complicações
18.
J Vet Med Sci ; 85(12): 1257-1260, 2023 Dec 06.
Artigo em Inglês | MEDLINE | ID: mdl-37880141

RESUMO

This study investigated the preventive effect of 5-aminolevulinic acid combined with sodium ferrous citrate (5-ALA/SFC) on blood-aqueous barrier (BAB) breakdown induced after anterior chamber paracentesis (ACP) in beagles. 5-ALA/SFC (1/0.64 mg/kg or 3/1.92 mg/kg) or carprofen (4.0 mg/kg) was orally administered daily for 7 days prior to ACP. Then, a sample of the aqueous humor (AH) was collected from one eye via ACP (first sample) and again 60 min later (second sample). The protein and prostaglandin E2 (PGE2) concentrations in both samples were measured. Compared with the control group, high-dose 5-ALA/SFC and carprofen significantly reduced the AH protein and PGE2 concentrations in the second sample. Our findings suggest that 5-ALA/SFC suppresses BAB breakdown in dogs.


Assuntos
Barreira Hematoaquosa , Paracentese , Animais , Cães , Paracentese/veterinária , Barreira Hematoaquosa/metabolismo , Ácido Aminolevulínico/farmacologia , Ácido Aminolevulínico/metabolismo , Dinoprostona/metabolismo , Câmara Anterior , Humor Aquoso
19.
Mayo Clin Proc ; 98(9): 1347-1352, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37661143

RESUMO

Patients with advanced emphysema frequently experience severe dyspnea that is inadequately treated with medical therapy alone. Over the past 4 years, we have seen increased usage of bronchoscopic lung volume reduction (BLVR) with endobronchial valves. Success of the procedure is dependent on patient selection because it is not necessarily appropriate for all patients with severe emphysema. (Table 1) The purpose of this review is to highlight the selection process at a single institution. We also discuss the influence of this process on outcomes. Between March 1, 2019, and October 12, 2021, 2402 patients were referred to a dedicated chronic obstructive pulmonary disease clinic at Mayo Clinic - Rochester, whereas 161 patients were subsequently referred for multidisciplinary BLVR review. Of those patients, 53 (32.9%) were selected to receive valves and 35 (21.7%) ultimately underwent the procedure. The main reasons for exclusion included an incompatible quantitative computed tomography analysis (n=37, 34.3%), presence of pulmonary nodule or active malignancy (n=14, 13.0%), or need for completion of pulmonary rehabilitation (n=9, 8.3%). Full or partial (>70%) target lobe collapse was observed in 58.6% of patients who received valves. Those with collapse experienced statistically significant improvements in spirometric measures. Twelve patients experienced a pneumothorax (34.3%), with 10 patients requiring thoracostomy tube placement and prolonged hospitalization (median, 11 days; range, 4-39 days). Nineteen patients required a secondary procedure within the first year. The study highlights how a multidisciplinary approach to the BLVR selection process enables individualization of a complex procedure and enhances the exclusion of inappropriate candidates.


Assuntos
Enfisema , Pneumonectomia , Humanos , Seleção de Pacientes , Instituições de Assistência Ambulatorial , Paracentese
20.
Trials ; 24(1): 534, 2023 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-37582719

RESUMO

BACKGROUND: Critically ill patients with cirrhosis and ascites are at high risk for intra-abdominal hypertension (IAH) which increases mortality. Clinical guidelines recommend maintaining intra-abdominal pressure (IAP) below 16 mmHg; nonetheless, more than three quarters of critically ill patients with cirrhosis develop IAH during their first week of ICU stay. Standard-of-care intermittent large-volume paracentesis (LVP) relieves abdominal wall tension, reduces IAP, optimizes abdominal perfusion pressure, and is associated with short-term improvement in renal and pulmonary dysfunction. However, there is no evidence of the superiority of different paracentesis strategies in the prevention and treatment of IAH in critically ill patients with cirrhosis. This trial aims to compare the outcomes of continuous passive paracentesis versus LVP in the prevention and treatment of IAH in patients with cirrhosis and ascites. METHODS: An investigator-initiated, open label, randomized controlled trial, set in a general ICU specialized in liver disease, was initiated in August 2022, with an expected duration of 36 months. Seventy patients with cirrhosis and ascites will be randomly assigned, in a 1:1 ratio, to receive one of two methods of therapeutic paracentesis. A stratified randomization method, with maximum creatinine and IAP values as strata, will homogenize patient baseline characteristics before trial group allocation, within 24 h of admission. In the control group, LVP will be performed intermittently according to clinical practice, with a maximum duration of 8 h, while, in the intervention group, continuous passive paracentesis will drain ascitic fluid for up to 7 days. The primary endpoint is serum creatinine concentration, and secondary endpoints include IAP, measured creatinine clearance, daily urine output, stage 3 acute kidney injury and multiorgan dysfunction assessed at day 7 after enrollment, as well as 28-day mortality rate and renal replacement therapy-free days, and length-of-stay. Prespecified values will be used in case of renal replacement therapy or, beforehand ICU discharge, liver transplant and death. Safety analysis will include paracentesis-related complication rate and harm. Data will be analyzed with an intention-to-treat approach. DISCUSSION: This is the first trial to compare the impact of different therapeutic paracentesis strategies on organ dysfunction and outcomes in the prevention and treatment of IAH in critically ill patients with cirrhosis and ascites. TRIAL REGISTRATION: ClinicalTrials.gov NCT04322201 . Registered on 20 December 2019.


Assuntos
Hipertensão Intra-Abdominal , Paracentese , Humanos , Paracentese/efeitos adversos , Paracentese/métodos , Ascite/diagnóstico , Ascite/etiologia , Ascite/terapia , Estado Terminal , Hipertensão Intra-Abdominal/diagnóstico , Hipertensão Intra-Abdominal/etiologia , Hipertensão Intra-Abdominal/terapia , Creatinina , Cirrose Hepática/complicações , Cirrose Hepática/diagnóstico , Cirrose Hepática/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto
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