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1.
Orphanet J Rare Dis ; 14(1): 231, 2019 Oct 22.
Artigo em Inglês | MEDLINE | ID: mdl-31640729

RESUMO

BACKGROUND: PMM2-CDG (Phosphomannomutase 2 - Congenital disorder of glycosylation-Ia; CDG-Ia) is the most common glycosylation defect, often presenting as a severe multisystem disorder that can be fatal within the first years of life. While mannose treatment has been shown to correct glycosylation in vitro and in vivo in mice, no convincing effects have been observed in short-term treatment trials in single patients so far. RESULTS: We report on a boy with a severe PMM2-CDG who received a continuous intravenous mannose infusion over a period of 5 months during the first year of life in a dose of 0.8 g/kg/day. N-glycosylation of serum glycoproteins and mannose concentrations in serum were studied regularly. Unfortunately, no biochemical or clinical improvement was observed, and the therapy was terminated at age 9 months. CONCLUSION: Postnatal intravenous D-mannose treatment seems to be ineffective in PMM2-CDG.

2.
Surg Endosc ; 2019 Oct 28.
Artigo em Inglês | MEDLINE | ID: mdl-31659506

RESUMO

BACKGROUND: Minimally invasive single-port surgery is often associated with large incisions up to 2-3 cm, complicated handling due to the lack of triangulation, and instrument crossing. Aim of this prospective study was to perform true single-port surgery (cholecystectomy) without the use of assisting trocars using a new surgical platform that allows for triangulation incorporating robotic features, and to measure the perioperative outcome and cosmetic results. METHODS: As the first European site after FDA and CE-mark approval, the new device has been introduced to our academic center. In patients with cholecystitis and cholecystolithiasis, the operation was performed through only one 15-mm trocar. For patients safety, intraoperative cholangiography using intravenous ICG and a standard Stryker 1588 system was routinely performed. RESULTS: Symphonx was used in n = 12 patients for abdominal surgery (6 females, mean age 42.5 [30-77], mean BMI 26.2 [19.3-38.9]. A total of 8 patients underwent surgery using no additional ports besides the 15-mm trocar; in the remaining patients, one assisting instrument (3-5 mm) was used. Mean OR time was 107 [72-221] minutes. The postoperative course was uneventful in 11 patients; in one patient, a seroma at the surgical site required interventional drainage 1 month postoperatively. No intraoperative complications occurred. CONCLUSION: This is the first human case series using the commercially available symphonX platform for abdominal laparoscopic surgery and the first series using the system without assisting instruments. Laparoscopic cholecystectomy in patients with cholecystitis and cholecystolithiasis using the symphonX platform through only one 15-mm trocar is feasible, safe, and more cost-efficient compared to robotic platforms.

3.
BMC Cancer ; 19(1): 531, 2019 May 31.
Artigo em Inglês | MEDLINE | ID: mdl-31151416

RESUMO

BACKGROUND: Molecular markers predicting survival in esophageal adenocarcinoma (EAC) are rare. Specifically, in favorable oncologic situations, e.g. nodal negativity or major neoadjuvant therapy response, there is a lack of additional risk factors that serve to predict patients' outcome more precisely. This study evaluated X-linked inhibitor of apoptosis protein (XIAP) as a potential marker improving outcome prediction. METHODS: Tissue microarrays from 362 patients that were diagnosed with resectable EAC were included in the study. XIAP was stained by immunohistochemistry and correlated to clinical outcome, molecular markers and markers of the cellular tumor microenvironment. RESULTS: XIAP did not impact on overall survival (OS) in the whole study collective. Subgroup analyses stratifying for common genetic markers (TP53, ERBB2, ARID1A/SWI/SNF) did not disclose any impact of XIAP expression on survival. Detailed subgroup analyses of [1] nodal negative patients, [2] highly T-cell infiltrated tumors and [3] therapy responders to neoadjuvant treatment revealed a significant inverse role of high XIAP expression in these specific oncologic situations; elevated XIAP expression detrimentally affected patients' outcome in these subgroups. [1]: OS XIAP low: 202 months (m) vs. XIAP high: 38 m; [2]: OS 116 m vs. 28.2 m; [3]: OS 31 m vs. 4 m). CONCLUSIONS: Our data suggest XIAP expression in EAC as a worthy tool to improve outcome prediction in specific oncologic settings that might directly impact on clinical diagnosis and treatment of EAC in the future.

4.
Trials ; 20(1): 299, 2019 May 28.
Artigo em Inglês | MEDLINE | ID: mdl-31138290

RESUMO

BACKGROUND: Three-dimensional (3D) stereoscopic vision is crucial to perform any kind of manual task. The reduction from real life 3D to virtual two-dimensional (2D) sight is a major challenge in minimally invasive surgery (MIS). A 3D display technique has been shown to reduce operation time and mistakes and to improve the learning curve. Therefore, the use of a3D display technique seems to optimize surgical performance for novice and experienced surgeons. Inspired by consumer electronics, a 4K display technique was recently introduced to MIS. Due to its high resolution and zoom effect, surgeons should benefit from it. The aim of this study is to evaluate if "state-of-the-art" 3D- vs. 4K-display techniques could influence surgical performance. METHODS: A randomized, cross-over, single-institution, single-blinded trial is designed. It compares the primary outcome parameter "surgical performance", represented by "performance time "and "number of mistakes", using a passive polarizing 3D and a 4K display system (two arms) to perform different tasks in a minimally invasive/laparoscopic training parkour. Secondary outcome parameters are the mental stress load (National Aeronautics and Space Administration (NASA) Task Load Index) and the learning curve. Unexperienced novices (medical students), non-board-certified, and board-certified abdominal surgeons participate in the trial (i.e., level of experience, 3 strata). The parkour consists of seven tasks (for novices, five tasks), which will be repeated three times. The 1st run of the parkour will be performed with the randomized display system, the 2nd run with the other one. After each run, the mental stress load is measured. After completion of the parkour, all participants are evaluated by an ophthalmologist for visual acuity and stereoscopic vision with five tests. Assuming a correlation of 0.5 between measurements per subject, a sample size of 36 per stratum is required to detect a standardized effect of 0.5 (including an additional 5% for a non-parametric approach) with a power of 80% at a two-sided type I error of 5%. Thus, altogether 108 subjects need to be enrolled. DISCUSSION: Complex surgical procedures are performed in a minimally invasive/laparoscopic technique. This study should provide some evidence to decide which display technique a surgeon could choose to optimize his performance. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03445429 . Registered on 7 February 2018.

5.
Pediatr Pulmonol ; 54(6): 759-764, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30997755

RESUMO

OBJECTIVES: The carbon dioxide (CO2 ) diffusion coefficient (DCO 2 ) reflects CO 2 removal during high-frequency oscillatory ventilation (HFOV). We hypothesized that despite leak flow during noninvasive HFOV (nHFOV) DCO 2 continues to indicate ventilation efficacy. METHODS: A neonatal airway model including CO2 production and an adjustable oropharyngeal leak was connected to a ventilator via bi-nasal prongs. Pressures and gas flows were measured at prongs, trachea, and leak. Oscillatory tidal volumes below (V T trachea ) and above the leak (V T prong ) were calculated from tracheal and leak flows. DCO 2 was calculated using V T trachea (DCO 2 trachea ) and V T prong (DCO 2 prong ) and compared with CO 2 partial pressure (pCO 2 ). Effects of leak flow (0, 5, or 10 L/min) on DCO 2 were assessed at fixed pressure amplitudes or predefined oscillatory volumes under steady-state pCO 2 conditions in the modeled lung. RESULTS: DCO2 trachea correlated strongly with pCO 2 , independent of the leak flow level (P < 0.0001). DCO 2 prong correlated with pCO 2 without and with moderate leak (P < 0.0001) but not with maximum leak (P = 0.1432). V T trachea correlated with the quotient of tracheal pressure amplitude and frequency irrespective of the leak (P < 0.0001). Based on the pressure amplitude at prong level (A prong ) V T trachea continued to follow a linear model of which the slopes decreased with increasing leak flow. V T prong correlated with the quotient of A prong and frequency, irrespective of the leak (P < 0.0001). CONCLUSIONS: DCO2 obtained at the airway opening at prong level reflects ventilation efficacy during nHFOV even in the presence of moderate oropharyngeal leak.

6.
Trials ; 20(1): 178, 2019 Mar 20.
Artigo em Inglês | MEDLINE | ID: mdl-30894226

RESUMO

BACKGROUND: Transition immediately after birth is a complex physiological process. The neonate has to establish sufficient ventilation to ensure significant changes from intra-uterine to extra-uterine circulation. If hypoxia or bradycardia or both occur, as commonly happens during immediate transition in preterm neonates, cerebral hypoxia-ischemia may cause perinatal brain injury. The primary objective of the COSGOD phase III trial is to investigate whether it is possible to increase survival without cerebral injury in preterm neonates of less than 32 weeks of gestation by targeting cerebral tissue oxygen saturation (crSO2) using specified clinical treatment guidelines during the immediate transition period after birth (the first 15 min) in addition to the routine monitoring of arterial oxygen saturation (SpO2) and heart rate (HR). METHODS/DESIGN: COSGOD III is an investigator-initiated, randomized, multi-center, multi-national, phase III clinical trial. Inclusion criteria are neonates of less than 32 weeks of gestation, decision to provide full life support, and parental informed consent. Exclusion criteria are severe congenital malformations of brain, heart, lung, or prenatal cerebral injury or a combination of these. The premature infants will be randomly assigned to study or control groups. Both groups will have a near-infrared spectroscopy (NIRS) device (left frontal), pulse oximeter (right palm/wrist), and electrocardiogram placed immediately after birth. In the study group, the crSO2, SpO2, and HR readings are visible, and the infant will receive treatment in accordance with defined treatment guidelines. In the control group, only SpO2 and HR will be visible, and the infant will receive routine treatment. The intervention period will last for the first 15 min after birth during the immediate transition period and resuscitation. Thereafter, each neonate will be followed up for primary outcome to term date or discharge. The primary outcome is mortality or cerebral injury (or both) defined as any intra-ventricular bleeding or cystic periventricular leukomalacia (or both). Secondary outcomes are neonatal morbidities. DISCUSSION: crSO2 monitoring during immediate transition has been proven to be feasible and improve cerebral oxygenation during immediate transition. The additional monitoring of crSO2 with dedicated interventions may improve outcome of preterm neonates as evidenced by increased survival without cerebral injury. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03166722 . Registered March 5, 2017.


Assuntos
Encéfalo/metabolismo , Oxigênio/administração & dosagem , Ensaios Clínicos Controlados Aleatórios como Assunto , Cardiotocografia , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Avaliação de Resultados (Cuidados de Saúde) , Oxigênio/metabolismo , Guias de Prática Clínica como Assunto , Projetos de Pesquisa , Espectroscopia de Luz Próxima ao Infravermelho
7.
World J Gastroenterol ; 25(3): 388-397, 2019 Jan 21.
Artigo em Inglês | MEDLINE | ID: mdl-30686906

RESUMO

BACKGROUND: The clinical presentation of gastroesophageal reflux disease (GERD) shows a large symptom variation also in different intensities among patients. As several studies have shown, there is a large overlap in the symptomatic spectrum between proven GERD and other disorders such as dyspepsia, functional heartburn and/or somatoform disorders. AIM: To prospectively evaluate the GERD patients with and without somatoform disorders before and after laparoscopic antireflux surgery. METHODS: In a tertiary referral center for foregut surgery over a period of 3 years patients with GERD, qualifying for the indication of laparoscopic antireflux surgery, were investigated prospectively regarding their symptomatic spectrum in order to identify GERD and associated somatoform disorders. Assessment of symptoms was performed by an instrument for the evaluation of somatoform disorders [Somatoform Symptom Index (SSI) > 17]. Quality of life was evaluated by Gastrointestinal Quality of Life Index (GIQLI). RESULTS: In 123 patients an indication for laparoscopic antireflux surgery was established and in 43 patients further medical therapy was suggested. The portion of somatoform tendencies in the total patient population was 20.48% (34 patients). Patients with a positive SSI had a preoperative GIQLI of 77 (32-111). Patients with a normal SSI had a GIQLI of 105 (29-140) (P < 0.0001). In patients with GERD the quality of life could be normalized from preoperative reduced values of GIQLI 102 (47-140) to postoperative values of 117 (44-144). In patients with GERD and somatoform disorders, the GIQLI was improved from preoperative GIQLI 75 (47-111) to postoperative 95 (44-122) (P < 0.0043). CONCLUSION: Patients with GERD and associated somatoform disorders have significantly worse levels of quality of life. The latter patients can also benefit from laparoscopic fundoplication, however they will not reach a normal level.


Assuntos
Fundoplicatura , Refluxo Gastroesofágico/cirurgia , Qualidade de Vida , Transtornos Somatoformes/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Refluxo Gastroesofágico/diagnóstico , Refluxo Gastroesofágico/psicologia , Humanos , Laparoscopia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Psicometria , Transtornos Somatoformes/diagnóstico , Transtornos Somatoformes/psicologia , Resultado do Tratamento , Adulto Jovem
8.
Front Pediatr ; 6: 235, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30234076

RESUMO

Background: Breast milk (BM) for premature infants is subjected to multiple steps of processing, storage and distribution. These steps may influence the quality and safety of BM. Guidelines concerning the use of mother's own milk are either not available or limited to specific aspects of BM handling and are based on evidence of variable strength. This may result in diverse BM handling routines by health care professionals. Objective: We surveyed neonatal units to increase the knowledge about the current practice of BM handling routines of mother's own milk and to identify controversial aspects that could give directions for future research. Methods: An online-based questionnaire was sent to 307 different neonatal departments providing level III to level I neonatal care within Germany, Austria and Switzerland. Practices concerning screening for cytomegalovirus and BM bacteria, pasteurization, fortification, storage, workforce and the incidence of BM administration errors were surveyed. Results: A total of 152 units, 56% of contacted level III units and 51% of level II units, participated in the survey (Germany 53%, Switzerland 71%, and Austria 56%). We found differences concerning indication and method of CMV inactivation (performed by 58%), bacterial count screening (48%) and bacterial count reduction (17%) within participating units. Thirty different thresholds for bacterial BM counts were reported by 65 units, resulting in pasteurization or discarding of BM. The use of nutrient analysis (12%) and fortification regimens in addition to standard multicomponent fortifiers (58%) using either individual (93%), targeted (3%), or adjusted (4%) fortification protocols varied profoundly. There is a high variability in staff and available facilities for BM handling. 73% of units report about BM administration errors. Conclusion: There is a wide variability in most aspects of BM handling in the participating units. Despite limited evidence labor and cost intensive procedures are applied which may have an impact on BM quality.

9.
Klin Padiatr ; 230(4): 194-199, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29544230

RESUMO

BACKGROUND: Transumbilical laparoscopic-assisted appendectomy (TULAA) is fast and cost-effective since no endoloops, staplers or wound protection devices are used. We analyzed the effects of TULAA as first approach for perforated (PA) and non-perforated (NPA) appendicitis in children. PATIENTS: We performed a retrospective analysis of 181 children for whom TULAA was the first approach for appendicitis between October 2010 and March 2016. METHODS: Morbidity, additional laparoscopic instrument insertion (AI), conversions to open extraumbilical appendectomy (OC), and complications were evaluated. RESULTS: TULAA was initiated in 181 (87.4%) children (113 boys: 68 girls). Median age was 10.3 years (3.3-13.9 years) and BMI 16.8 kg/m2 (12.4-30.8). Appendicitis was non-perforated in 157 (86.7%) and perforated in 24 (13.3%) patients. TULAA was finalized in 142 (78.5%) patients, AI were inserted in 20 (11%) and OC were performed in 19 (10.5%) patients. Duration of surgery did not exceed 20 min for 12.8%, and 30 min for 43.6% of patients with TULAA and NPA. The rate of wound infections did not differ between procedures (TULAA 3/142 (2.1%), AI 0 (0%), OC 1/19 (5.3%), P=1.000). Further postoperative course was uneventful in 179 (98.9%) patients. CONCLUSION: TULAA can be used as first approach for appendicitis in all children with a low rate of complications. Extracorporeal appendix stump closure can be safely achieved in the majority of children without using laparoscopic disposable devices.

10.
J Laparoendosc Adv Surg Tech A ; 28(4): 439-444, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29432050

RESUMO

AIM: Over-the-scope-clip (OTSC) System is a relatively new endoluminal intervention for gastrointestinal (GI) leaks, fistulas, and bleeding. Here, we present a single center experience with the device over the course of 4 years. METHODS: Retrospective chart review was conducted for patients who received endoscopic OTSC treatment. Primary outcome is the resolution of the original indication for clip placement. Secondary outcomes are complications and time to resolution. RESULTS: Forty-one patients underwent treatment with the OTSC system from 2011 to 2015 with average follow-up of 152 days. The average age is 53.7. The most common site of clip placement was in the stomach (44%). Clips were placed after surgical complication for 28 patients (68%), endoscopic complications for 8 patients (19%), and spontaneous presentation in 5 patients (12%). Technical success was achieved in all patients. Overall, 34 patients (83%) were successfully treated. Nine patients required multiple clips and three patients required additional treatment modalities after OTSC. Four patients used the OTSC as a bridging therapy to surgery. Using OTSC for palliation versus nonpalliative indications was associated with lower rates of treatment success (50% versus 86%, P = .028). Using OTSC for symptoms <6 months had higher rates of treatment success than those experiencing longer symptoms (88% versus 65%, P = .045). There were no major morbidities or mortalities directly associated with the OTSC system. Complications from clip use were pain in two patients (5%) and hematemesis in one patient (3%). CONCLUSIONS: The OTSC System can be a very successful treatment for iatrogenic or spontaneous GI leaks and bleeds. Treatment success is more likely in patients treated within 6 months of diagnosis and less likely to when used for palliation. It was also successfully used as bridging therapy in several patients.


Assuntos
Fístula Anastomótica/cirurgia , Fístula do Sistema Digestório/cirurgia , Endoscopia Gastrointestinal/efeitos adversos , Endoscopia Gastrointestinal/instrumentação , Hemorragia Gastrointestinal/cirurgia , Adulto , Idoso , Endoscopia Gastrointestinal/métodos , Desenho de Equipamento , Feminino , Humanos , Masculino , Microcirurgia , Pessoa de Meia-Idade , Estudos Retrospectivos , Instrumentos Cirúrgicos/efeitos adversos , Resultado do Tratamento
11.
Neonatology ; 113(3): 221-230, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29298438

RESUMO

BACKGROUND: Levels or fluctuations in the partial pressure of CO2 (PCO2) may affect outcomes for extremely low birth weight infants. OBJECTIVES: In an exploratory analysis of a randomized trial, we hypothesized that the PCO2 values achieved could be related to significant outcomes. METHODS: On each treatment day, infants were divided into 4 groups: relative hypocapnia, normocapnia, hypercapnia, or fluctuating PCO2. Ultimate assignment to a group for the purpose of this analysis was made according to the group in which an infant spent the most days. Statistical analyses were performed with analysis of variance (ANOVA), the Kruskal-Wallis test, the χ2 test, and the Fisher exact test as well as by multiple logistic regression. RESULTS: Of the 359 infants, 57 were classified as hypocapnic, 230 as normocapnic, 70 as hypercapnic, and 2 as fluctuating PCO2. Hypercapnic infants had a higher average product of mean airway pressure and fraction of inspired oxygen (MAP × FiO2). For this group, mortality was higher, as was the likelihood of having moderate/severe bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), and poorer neurodevelopment. Multiple logistic regression analyses showed an increased risk for BPD or death associated with birth weight (p < 0.001) and MAP × FiO2 (p < 0.01). The incidence of adverse neurodevelopment was associated with birth weight (p < 0.001) and intraventricular hemorrhage (IVH; p < 0.01). CONCLUSIONS: Birth weight and respiratory morbidity, as measured by MAP × FiO2, were the most predictive of death or BPD and NEC, whereas poor neurodevelopmental outcome was associated with low birth weight and IVH. Univariate models also identified PCO2. Thus, hypercapnia seems to reflect greater disease severity, a likely contributor to differences in outcomes.

12.
J Laparoendosc Adv Surg Tech A ; 28(4): 422-428, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29327976

RESUMO

BACKGROUND: Perforation of the esophagus is the most severe complication of transesophageal echocardiography (TEE) and can lead to mediastinitis, pleural empyema, or peritonitis. Currently, the majority of patients receive operative treatment with only 6% treated endoscopically. We report our experience with endoscopic and conservative approaches. METHODS: We retrospectively reviewed all patients treated for esophageal perforation and included all patients with perforation caused by TEE. All patients with perforation of the esophagus by TEE probe underwent conservative or endoscopic treatment, drainage of pleural and mediastinal retentions, and adjusted to antibiotic therapy. RESULTS: From January 2004 to December 2014 a total of 109 patients were treated for esophageal perforation in our department. In 6 patients (5.5%) the perforation was caused by TEE. Location was cervical and midthoracic in 2 and 4 cases, respectively. All patients underwent successful endoscopic treatment and no further surgical procedure, such as esophageal suture or resection was necessary. The mean time between TEE and therapy of the perforation was 7.3 days. In all patients closure of the leakage could be achieved within 30 days. Mortality rate was 0%. CONCLUSIONS: Esophageal perforations caused by TEE are typically small, in the cervical and mid esophagus, and minimally contaminated. These are good prognostic factors for successful endoscopic treatment with preservation of the esophagus. Operative treatment should only be considered in cases of failed endoscopic treatment.


Assuntos
Tratamento Conservador , Ecocardiografia Transesofagiana/efeitos adversos , Endoscopia Gastrointestinal , Perfuração Esofágica/etiologia , Perfuração Esofágica/terapia , Adulto , Idoso de 80 Anos ou mais , Antibacterianos/uso terapêutico , Drenagem , Feminino , Humanos , Pessoa de Meia-Idade , Estudos Retrospectivos
13.
Surg Endosc ; 32(4): 1906-1914, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29218673

RESUMO

BACKGROUND: Esophageal perforations and postoperative leakage of esophagogastrostomies are considered to be life-threatening conditions due to the potential development of mediastinitis and consecutive sepsis. Vacuum-assisted closure (VAC) techniques, a well-established treatment method for superficial infected wounds, are based on a negative pressure applied to the wound via a vacuum-sealed sponge. Endoluminal VAC (E-VAC) therapy as a treatment for GI leakages in the rectum was introduced in 2008. E-VAC therapy is a novel method, and experience regarding esophageal applications is limited. In this retrospective study, the experience of a high-volume center for upper GI surgery with E-VAC therapy in patients with leaks of the upper GI tract is summarized. To our knowledge, this series presents the largest patient cohort worldwide in a single-center study. METHODS: Between October 2010 and January 2017, 77 patients with defects in the upper gastrointestinal tract were treated using the E-VAC application. Six patients had a spontaneous perforation, 12 patients an iatrogenic injury, and 59 patients a postoperative leakage in the upper gastrointestinal tract. RESULTS: Complete restoration of the esophageal defect was achieved in 60 of 77 patients. The average duration of application was 11.0 days, and a median of 2.75 E-VAC systems were used. For 21 of the 77 patients, E-VAC therapy was combined with the placement of self-expanding metal stents. CONCLUSION: This study demonstrates that E-VAC therapy provides an additional treatment option for esophageal wall defects. Esophageal defects and mediastinal abscesses can be treated with E-VAC therapy where endoscopic stenting may not be possible. A prospective multi-center study has to be directed to bring evidence to the superiority of E-VAC therapy for patients suffering from upper GI defects.

14.
Arch Dis Child Fetal Neonatal Ed ; 103(4): F1-F5, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-28918395

RESUMO

OBJECTIVE: Non-invasive high-frequency oscillatory ventilation (nHFOV) has recently been described as a novel mode of respiratory support for premature infants. This study was designed to determine whether nHFOV decreases CO2 partial pressure (pCO2) in premature infants more effectively than non-invasive continuous positive airway pressure (nCPAP). DESIGN: Non-blinded prospective randomised controlled cross-over study. SETTING: University Medical Center tertiary neonatal intensive care unit. PATIENTS: 26 premature infants of 27±2 weeks of gestational age after extubation or non-invasive surfactant treatment. INTERVENTIONS: Infants were treated with 4 hours of nHFOV and 4 hours of nCPAP in a cross-over design. The sequence of the ventilation mode was randomly allocated. MAIN OUTCOME MEASURES: The primary outcome measure was pCO2 of arterial or arterialised blood 4 hours after commencing the respective mode of respiratory support. Secondary outcome criteria included events of apnoea and bradycardia, respiratory rate, heart rate, pain and/or discomfort, mean airway pressure, fraction of inspired oxygen and failure of non-invasive respiratory support. RESULTS: pCO2 after 4 hours of nHFOV was similar compared with 4 hours of nCPAP (p=0.33). pCO2 was 54.8 (14.6) vs 52.7 (9.3) mm Hg mean (SD) for the nHFOV-nCPAP period (n=13) and 49.0 (8.1) vs 47.7 (9.5) mm Hg for the nCPAP-nHFOV period (n=13). There was no difference in any of the secondary outcome measures. nHFOV was terminated prematurely in five cases for predefined failure criteria (p=0.051). CONCLUSIONS: We could not demonstrate an increased carbon dioxide clearance applying nHFOV compared with nCPAP in this cohort of preterm infants. TRIAL REGISTRATION NUMBER: DRKS00007171, results.


Assuntos
Ventilação de Alta Frequência/normas , Ventilação com Pressão Positiva Intermitente/métodos , Ventilação não Invasiva/normas , Insuficiência Respiratória/terapia , Dióxido de Carbono/sangue , Estudos Cross-Over , Feminino , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Ventilação com Pressão Positiva Intermitente/normas , Masculino , Pressão Parcial , Estudos Prospectivos
15.
Front Pediatr ; 5: 246, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29209598

RESUMO

Background: Ventilator-induced lung injury is considered to be a main factor in the pathogenesis of bronchopulmonary dysplasia (BPD). Optimizing ventilator strategies may reduce respiratory morbidities in preterm infants. Permissive hypercapnia has been suggested to attenuate lung injury. We aimed to determine if a higher PCO2 target range results in less lung injury compared to the control target range and possibly reduces pro-inflammatory cytokines and acid sphingomyelinase (ASM) in tracheal aspirates (TA), which has not been addressed before. Methods: During a multicenter trial of permissive hypercapnia in extremely low birthweight infants (PHELBI), preterm infants (birthweight 400-1,000 g, gestational age 23 0/7-28 6/7 weeks) requiring mechanical ventilation within 24 h of birth were randomly assigned to a high PCO2 target or a control group. The high target group aimed at PCO2 values of 55-65, 60-70, and 65-75 mmHg and the control group at PCO2 values of 40-50, 45-55 and 50-60 mmHg on postnatal days 1-3, 4-6, and 7-14, respectively. TA was analyzed for pro-inflammatory cytokines from postnatal day 2-21. BPD was determined at a postmenstrual age of 36 weeks ± 2 days. Main findings: Levels of inflammatory cytokines and ASM were similar in both groups: interleukin (IL)-6 (p = 0.14), IL-8 (p = 0.43), IL-10 (p = 0.24), IL-1ß (p = 0.11), macrophage inflammatory protein 1α (p = 0.44), albumin (p = 0.41), neuropeptide Y (p = 0.52), leukotriene B4 (p = 0.11), transforming growth factor-ß1 (p = 0.68), nitrite (p = 0.15), and ASM (p = 0.94). Furthermore, most inflammatory mediators were strongly affected by the age of the infants and increased from postnatal day 2 to 21. BPD or death was observed in 14 out of 62 infants, who were distributed evenly between both groups. Conclusion: The results suggest that high PCO2 target levels did not result in lower pulmonary inflammatory activity and thus reflect clinical results. This indicates that high PCO2 target ranges are not effective in reducing ventilator-induced lung injury in preterm infants, as compared to control targets. Trial registration: ISRCTN56143743.

17.
PLoS One ; 12(6): e0179974, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28632754

RESUMO

BACKGROUND: Controlled hypoventilation while accepting hypercapnia has been advocated to reduce ventilator-induced lung injury. The aim of the study was to analyze outcomes of a cohort of immunocompromised children with acute respiratory distress syndrome (ARDS) ventilated with a strategy of stepwise increasing PCO2 targets up to 140 mm Hg. METHODS: Retrospective analysis of outcomes of a cohort of children with oncologic disease or after stem cell transplantation and severe respiratory failure in comparison with a historical control cohort. RESULTS: Out of 150 episodes of admission to the PICU 88 children underwent invasive mechanical ventilation for >24h (overall survival 75%). In a subgroup of 38 children with high ventilator requirements the PCO2 target ranges were increased stepwise. Fifteen children survived and were discharged from the PICU. Severe pulmonary hypertension was seen in two patients and no case of cerebral edema was observed. Long term outcome was available in 15 patients and 10 of these patients survived without adverse neurological sequelae. With introduction of this strategy survival of immunocompromised children undergoing mechanical ventilation for >24h increased to 48% compared to 32% prior to introduction (historical cohort). CONCLUSIONS: A ventilation strategy incorporating very high carbon dioxide levels to allow for low tidal volumes and limited inspiratory pressures is feasible in children. Even severe hypercapnia may be well tolerated. No severe side effects associated with hypercapnia were observed. This strategy could potentially increase survival in immunocompromised children with severe ARDS.


Assuntos
Hipercapnia/patologia , Respiração Artificial , Síndrome do Desconforto Respiratório do Adulto/diagnóstico , Gasometria , Criança , Pré-Escolar , Feminino , Humanos , Hipercapnia/complicações , Hipercapnia/mortalidade , Hipertensão Pulmonar/complicações , Hospedeiro Imunocomprometido , Unidades de Terapia Intensiva Pediátrica , Tempo de Internação , Leucemia/terapia , Masculino , Respiração Artificial/efeitos adversos , Síndrome do Desconforto Respiratório do Adulto/complicações , Estudos Retrospectivos , Índice de Gravidade de Doença , Transplante de Células-Tronco , Taxa de Sobrevida
18.
PLoS One ; 12(1): e0169352, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28046032

RESUMO

BACKGROUND: Ventilated preterm infants frequently develop bronchopulmonary dysplasia (BPD) which is associated with elevated inflammatory mediators in their tracheal aspirates (TA). In animal models of BPD, inhaled nitric oxide (iNO) has been shown to reduce lung inflammation, but data for human preterm infants is missing. METHODS: Within a European multicenter trial of NO inhalation for preterm infants to prevent BPD (EUNO), TA was collected to determine the effects of iNO on pulmonary inflammation. TA was collected from 43 premature infants randomly assigned to receive either iNO or placebo gas (birth weight 530-1230 g, median 800 g, gestational age 24 to 28 2/7 weeks, median 26 weeks). Interleukin (IL)-1ß, IL-6, IL-8, transforming growth factor (TGF)-ß1, interferon γ-induced protein 10 (IP-10), macrophage inflammatory protein (MIP)-1α, acid sphingomyelinase (ASM), neuropeptide Y and leukotriene B4 were measured in serial TA samples from postnatal day 2 to 14. Furthermore, TA levels of nitrotyrosine and nitrite were determined under iNO therapy. RESULTS: The TA levels of IP-10, IL-6, IL-8, MIP-1α, IL-1ß, ASM and albumin increased with advancing postnatal age in critically ill preterm infants, whereas nitrotyrosine TA levels declined in both, iNO-treated and placebo-treated infants. The iNO treatment generally increased nitrite TA levels, whereas nitrotyrosine TA levels were not affected by iNO treatment. Furthermore, iNO treatment transiently reduced early inflammatory and fibrotic markers associated with BPD development including TGF-ß1, IP-10 and IL-8, but induced a delayed increase of ASM TA levels. CONCLUSION: Treatment with iNO may have played a role in reducing several inflammatory and fibrotic mediators in TA of preterm infants compared to placebo-treated infants. However, survival without BPD was not affected in the main EUNO trial. TRIAL REGISTRATION: NCT00551642.


Assuntos
Recém-Nascido Prematuro/metabolismo , Mediadores da Inflamação/metabolismo , Óxido Nítrico/administração & dosagem , Traqueia/metabolismo , Administração por Inalação , Albuminas/metabolismo , Análise de Variância , Estudos de Casos e Controles , Quimiocinas/metabolismo , Demografia , Feminino , Humanos , Recém-Nascido , Masculino , Nitritos/metabolismo , Esfingomielina Fosfodiesterase/metabolismo , Sucção , Tirosina/análogos & derivados , Tirosina/metabolismo
19.
Arch Dis Child Fetal Neonatal Ed ; 102(5): F376-F382, 2017 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28087725

RESUMO

BACKGROUND: Tolerating higher partial pressures of carbon dioxide (PCO2) in mechanically ventilated extremely low birthweight infants to reduce ventilator-induced lung injury may have long-term neurodevelopmental side effects. This study analyses the results of neurodevelopmental follow-up of infants enrolled in a randomised multicentre trial. METHODS: Infants (n=359) between 400 and 1000 g birth weight and 23 0/7-28 6/7 weeks gestational age who required endotracheal intubation and mechanical ventilation within 24 hours of birth were randomly assigned to high PCO2 or to a control group with mildly elevated PCO2 targets. Neurodevelopmental follow-up examinations were available for 85% of enrolled infants using the Bayley Scales of Infant Development II, the Gross Motor Function Classification System (GMFCS) and the Child Development Inventory (CDI). RESULTS: There were no differences in body weight, length and head circumference between the two PCO2 target groups. Median Mental Developmental Index (MDI) values were 82 (60-96, high target) and 84 (58-96, p=0.79). Psychomotor Developmental Index (PDI) values were 84 (57-100) and 84 (65-96, p=0.73), respectively. Moreover, there was no difference in the number of infants with MDI or PDI <70 or <85 and the number of infants with a combined outcome of death or MDI<70 and death or PDI<70. No differences were found between results for GMFCS and CDI. The risk factors for MDI<70 or PDI<70 were intracranial haemorrhage, bronchopulmonary dysplasia, periventricular leukomalacia, necrotising enterocolitis and hydrocortisone treatment. CONCLUSIONS: A higher PCO2 target did not influence neurodevelopmental outcomes in mechanically ventilated extremely preterm infants. Adjusting PCO2 targets to optimise short-term outcomes is a safe option. TRIAL REGISTRATION NUMBER: ISRCTN56143743.


Assuntos
Dióxido de Carbono/sangue , Desenvolvimento Infantil , Recém-Nascido de Peso Extremamente Baixo ao Nascer , Lactente Extremamente Prematuro , Respiração Artificial , Anti-Inflamatórios/efeitos adversos , Displasia Broncopulmonar/epidemiologia , Paralisia Cerebral/epidemiologia , Enterocolite Necrosante/epidemiologia , Feminino , Humanos , Hidrocortisona/efeitos adversos , Lactente , Recém-Nascido , Hemorragias Intracranianas/epidemiologia , Intubação Intratraqueal , Leucomalácia Periventricular/epidemiologia , Masculino , Testes Neuropsicológicos
20.
J Perinat Med ; 45(5): 613-617, 2017 Jul 26.
Artigo em Inglês | MEDLINE | ID: mdl-28099134

RESUMO

BACKGROUND: Neonatal hyperbilirubinemia is influenced by a wide variety of factors, one of which is hemolysis. Serious hyperbilirubinemia may lead to a kernicterus with detrimental neurologic sequelae. Patients suffering from hemolytic disease have a higher risk of developing kernicterus. Carbon monoxide (CO), a byproduct of hemolysis or heme degradation, was described by Sjöstrand in the 1960s. It is transported as carboxyhemoglobin (COHb) and exhaled through the lungs. We were interested in a potential correlation between COHb and total serum bilirubin (TSB) and the time course of both parameters. MATERIALS AND METHODS: We used a point of care (POC) blood gas analyzer and did a retrospective analysis of bilirubin and COHb data collected over a 60-day period. RESULTS: An arbitrary cut-off point set at 2% COHb identified four patients with hemolytic disease of different origins who required phototherapy. In one patient with atypical hemolytic uremic syndrome (aHUS), COHb preceded the rise in bilirubin by about 2 days. Despite this displacement, there was a moderately good correlation of COHb with TSB levels <15 mg/dL (257 µmol/L) (r2: 0.80) and direct bilirubin (r2: 0.78) in the first patient. For all the four patients and all time points the correlation was slightly lower (r2: 0.59). CONCLUSIONS: COHb might be useful as a marker for high hemoglobin turnover to allow an earlier identification of newborns at risk to a rapid rise in bilirubin.


Assuntos
Bilirrubina/metabolismo , Carboxihemoglobina/metabolismo , Hiperbilirrubinemia/sangue , Biomarcadores/sangue , Humanos , Recém-Nascido , Estudos Retrospectivos
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