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COMPLETED PROJECTS
PROVHILO
Title: PROtective Ventilation with HIgh or LOw positive end-expiratory pressure for open abdominal surgery
Aim: To determine whether a strategy with higher PEEP plus recruitment maneuvers improves clinical outcome in patients at high risk for postoperative pulmonary complications receiving mechanical ventilation during general anesthesia for open abdominal surgery Design: International multicenter double-blind randomized controlled two-arm trial Population: Patients planned for open abdominal surgery Status: Completed (900 patients were included) Publication: Accepted for publication in LANCET
Link to trial site: PROVHILO trial site Link to clinicaltrials.gov: Description of study details Link to publication in TRIALS (rational and study design): Trials 2011; 12:111 Link to publication in Lancet: Lancet 2014; 384: 495
Email: PROVHILOtrial@gmail.com Substudies of PROVHILO: Title: Association Between Postoperative Spirometry Test Results, Intraoperative PEEP and Postoperative Pulmonary Complications - a Substudy of the Multicenter Randomized Controlled Trial Comparing High versus Low PEEP during General Anesthesia for Open Abdominal Surgery
Design: Pre-planned single-center substudy testing the hypothesis that post–operative spirometry test results are dependent on the level of PEEP and the occurrence of postoperative pulmonary complications Population: This substudy included 63 patients; 32 patients were randomized to the higher PEEP group, 31 patients were randomized to the lower PEEP group Status: Finished Publication: Accepted for publication in European Journal of Anaesthesiology Link to publication in European Journal of Anaesthesiology: Eur J Anaesthesiol. 2017 Apr; 34:229 Title: Association between Systemic Levels of Biomarkers for Lung Injury, Intraoperative PEEP and Postoperative Pulmonary Complications - a Substudy of the Multicenter Randomized Controlled Trial Comparing High versus Low PEEP during General Anesthesia for Open Abdominal Surgery Design: Pre-planned multi-center substudy testing the hypothesis that per- and postoperative systemic levels of biomarkers for lung injury are dependent on the level of PEEP and the occurrence of postoperative pulmonary complications Population: This substudy included 258 patients from 6 centers that participated in PROVHILO Status: Finished Publication: Accepted for publication in European Journal of Anaesthesiology Link to publication in European Journal of Anaesthesiology: Eur J Anaesthesiol. 2017 Apr; 34:229 Title: Respiratory system mechanics during low versus high positive
end-expiratory pressure in open abdominal surgery – A substudy of PROVHILO randomized
controlled trial
Design: Post-hoc two-center substudy investigating
how high and low PEEP impact intra-tidal overdistension and recruitment/derecruitment.
Population: This substudy included 36 patients from 2 centers that participated in the PROVHILO trial. Status: Finished Publication: Accepted for publication in Anesthesia & Analgesia Link to publication in Anesthesia and Analgesia: Anesthesia and Analgesia 2018 Jan; 126:143 Design: Secondary analysis of the 'PROtective Ventilation with HIgh or LOw PEEP' trial. Population: Adult patients scheduled for abdominal surgery who are at risk of PPCs. Status: Finished Publication: Accepted for publication in European Journal of Anaesthesiology Link to publication in European Journal of Anaesthesiology: Eur J Anaesthesiol. 2018 Jun; in press LAS VEGAS Title: Local ASsessment of VEntilatory management during General Anesthesia for Surgery Aim: To assess the dependence of postoperative pulmonary complications on intra-operative MV settings and to characterize current mechanical ventilation practices during general anesthesia for surgery Design: International prospective observational 7-day cohort study Population: All patients undergoing general anesthesia in the operating room Status: Completed (10,500 patients were included) - analysis finished Publication: Accepted for publication in European Journal of Aaesthesiology Link to trial site: LAS VEGAS trial site Link to clinicaltrials.gov: Description of study details Link to publication in European Journal of Anaesthesiology (rational and study design): Eur J Anaesthesiol 2013; 30:205-7 Link to publication in European Journal of Anaesthesiology: soon available Link to planned substudies / subanalyses: LAS VEGAS Subanalyses Soon the LAS VEGAS dataset will be shared, for information see: LAS VEGAS - rules for data sharing Substudies of LAS VEGAS: Title: Intraoperative ventilation settings and their associations with postoperative pulmonary complications in obese patients Design: Pre-planned analysis of LAS VEGAS testing the hypothesis that that obese patients receive non-protective ventilation strategies, and that the occurrence of PPCs depends on the intraoperative ventilation settings. Population: This substudy included 2012 patients from 135 centers that participated in LAS VEGAS Status: Finished Publication: Accepted for publication in British Journal of Anesthesiology Link to publication in British Journal of Anesthesiology: Br J Anaesthesiol. 2018 in press iVENT
Title: International Survey on VENTilation Practice
Aim: To assess the individual routine ventilation practice in adult patients with healthy lung of anesthesiologists working in all kinds of occupation
Design: International online survey Population: All anesthesiologists in all kinds of occupation Status: Survey is completed - analysis ongoing Link to trial site: iVENT website Link to survey: Survey is closed PRoVENT Title: PRactice of VENTilation in critically ill patients without ARDS Aim: To determine ventilation practice and outcomes of intubated and ventilated intensive care unit patients without acute respiratory distress syndrome at the onset of mechanical ventilation Design: International multi-center observational 7-day cohort study Population: Intensive care unit patients intubated with an expected duration of ventilation longer than 24 hours Status: Completed (1,011 patients were included) - analysis finished Publication: Accepted for publication in LANCET RM Link to trial site: PRoVENT website Link to clinicaltrials.gov: Description of study details Email: proventtrial@gmail.com Link to publication in Journal of Clinical Trials (rational and study design): J Clin Trial 2013;3:4 Link to publication in Lancet RM: Lancet RM 2016 November; 4:882 Substudies of PRoVENT: Title: Potentially Modifiable Respiratory Variables Contributing to Outcome in ICU Patients Without ARDS – a secondary analysis of PRoVENT
Design: A pre–defined secondary analysis to examine factors associated with mortality. The primary endpoint was all–cause in–hospital mortality.
Population: Intensive care unit patients intubated with an expected duration of ventilation longer than 24 hours Status: Completed (1,011 patients were included) - analysis finished Publication: Accepted for publication in Annals of Intensive Care Link to publication in Annals of Intensive Care: Annals of Intensive Care 2018 in press HEPBURN Title: Randomized controlled trial investigating the efficacy and safety of nebulized HEParin versus placebo in BURN patients with inhalation trauma Aim: To determine the effect of nebulized heparin, compared to placebo, on the number of ventilator-free days at day 28, in burn patients with confirmed inhalation trauma requiring mechanical ventilation Design: International multicenter double-blind randomized controlled two-arm trial Population: Burn patients with confirmed inhalation trauma requiring mechanical ventilation Status: Study is stopped prematurely, analyses are presently performed Link to trial site: Description of study details Link to clinicaltrials.gov: Description of study details Link to publication in TRIALS (rational and study design): Trials 2013; 15:91 Email: hepburn@amc.uva.nl NEBULAE Title: Effectiveness of routine nebulisation of mucolytic agents and bronchodilating drugs in intubated and mechanically ventilated intensive care unit patients Aim: To determine the effect of a strategy using routine nebulisation of mucolytics and bronchodilators as compared to a strategy that uses nebulisation of mucolytics or bronchodilators only on clinical indication on the number of ventilator free days at day 28 Design: National multicenter randomized controlled two-arm non-inferiority trial in The Netherlands Population: Mechanically ventilated adult intensive care unit patients, with anticipated ventilation duration > 24 hours Status: Finished Link to trial site: Description of study details Link to publication in TRIALS (rational and study design): Trials 2015; 16:389 Link to clinicaltrials.gov: Description of study details Email: nebulaetrial@gmail.com Link to publication in JAMA: JAMA 2018; in press ONGOING PROJECTS PROBESE Title: PRotective ventilation of OBESE patientsAim: To determine whether a strategy with higher PEEP (12 cmH2O) plus recruitment maneuvers improves clinical outcome in obese patients (BMI >=35) receiving mechanical ventilation during general anesthesia for surgery Design: International multicenter double-blind randomized controlled two-arm trial Population: Obese patients (BMI >=35) undergoing surgery under general anesthesia with duration of longer >2 hours Status: Enrollment has ended - data cleaning has started Link to trial site: PROBESE trial site Link to clinicaltrials.gov: Description of study details Link to publication in TRIALS (rational and study design): Trials 2017; 18:202 Email: probese@peg-dresden.de Substudies of PROBESE: Title: Association Between Postoperative Spirometry Test Results, Intraoperative PEEP and Postoperative Pulmonary Complications Design: Pre-planned single-center substudy testing the hypothesis that post–operative spirometry test results are dependent on the level of PEEP and the occurrence of postoperative pulmonary complications Population: Under development Status: Under development Title: Association between Systemic Levels of Biomarkers for Lung Injury, Intraoperative PEEP and Postoperative Pulmonary Complications Design: Pre-planned multi-center substudy testing the hypothesis that per- and postoperative systemic levels of biomarkers for lung injury are dependent on the level of PEEP and the occurrence of postoperative pulmonary complications Population: Under development Status: Under development LOCO Title: LOw versus COnventional Tidal Volumes during One–lung Ventilation for Minimally Invasive Esophagectomy – A Randomized Controlled TrialAim: To compare whether lung–protective mechanical ventilation versus traditionally mechanical ventilation during one-lung ventilation protects against postoperative pulmonary complications and increased levels of biomarkers for lung injury in patients undergoing minimally invasive transthoracic esophagectomy. Design: Single-center randomized controlled two-arm trial intervention: In the lung protective strategy tidal volumes of 6 ml/kg IBW during laparoscopy, reduced to 3 ml/kg IBW during thoracoscopy will be used, while in the traditionally mechanical ventilation tidal volumes of 10 ml/kg IBW during laparoscopy, reduced to 5 ml/kg IBW during thoracoscopy will be used. Population: 30 patients undergoing minimally invasive transthoracic esophagectomy Status: Recruitment has ended - analysis has started Link to trial site: not available Link to trial register: Description of study details Email: M.vanderwoude@zuyderland.nl
ViPS Title: Variable Pressure Support
Aim: To test whether variable as compared to non-variable pressure support ventilation reduces the duration of mechanical ventilation Design: International multicenter randomized controlled two-arm trial Population: Intensive care unit patients who are on controlled mechanical ventilation for more than 24 hours Status: Study is running Link to trial site: ViPS trial site
Link to clinicaltrials.gov: Description of study details Link to publication in TRIALS (rational and study design): Trials 2013; 14:363. Email: vips@peg-dresden.de PROVAR Title: PROtective VARiable ventilation trial
Aim: PROVAR compares non-variable (conventional) lung protective ventilation with variable lung protective ventilation regarding pulmonary function and inflammatory responses in patients planned for open abdominal surgery
Design: Single-center randomized controlled two-arm trial Population: Patients who will receive mechanical ventilation under general anesthesia for open abdominal surgery Status: Study is running Link to trial site: not yet available
Link to clinicaltrials.gov: Description of study details Link to publication in TRIALS (rational and study design): Trials 2014; 15:155 PReVENT - NL Title: PRotective VENTilation in patients without ARDS at start of ventilation - NL Aim: To determine whether a lung–protective ventilation strategy with lower tidal volumes (4-6 ml/kg PBW) compared to ventilation using traditionally sized tidal volumes (8-10 ml/kg PBW) in intubated and mechanically ventilated intensive care unit patients reduces length of ICU stay Design: National multicenter randomized controlled two-arm trial in The Netherlands Population: Intensive care unit patients without ARDS Status: Recruitment has ended, database is cleaned; report is being written Link to trial site: Description of study details Link to publication in TRIALS (rational and study design): Trials 2015; 16:226 Link to clinicaltrials.gov: Description of study details Link to analysis plan: Study Update and Statistical Analysis Plan LAMINAR Title: Local Assessment of MaNagement in BuRn Patients (LAMiNAR) – a prospective observational international multi–center cohort study Aim: To determine ventilation practice in burn centers worldwide, specifically to determine which tidal volumes and what levels of positive end-expiratory pressures are used; to determine the impact of ventilation variables on duration of mechanical ventilation and clinical outcome parameters Design: International prospective observational cohort study Population: Consecutive intubated and ventilated burn patients admitted to participating burn ICUs Status: Recruitment has ended Link to trial site: Description of study details Link to clinicaltrials.gov: Description of study details Email: g.j.glas@amc.uva.nl Rules for data sharing: LAMINAR - rules for data sharing AiRDRoP Title: Does Automated closed–loop ventilation Reduce the DRiving Pressure levels in patients with ARDS (AiRDRoP) – a single–center crossover study and randomized controlled trial Aim: To compare the driving pressure level between INTELLiVENT®–ASV and conventional lung protective ventilation in the acute and sub–acute phase of moderate or severe ARDS Design: AiRDRoP is an investigator–initiated, investigator–sponsored, single–center, combined crossover study and randomized controlled trial Population: 48 intubated and ventilated intensive care unit patients with moderate or severe ARDS Status: Study has started Link to publication on rational and study design: not yet available Link to clinicaltrials.gov: not yet available RELAx Title: REstricted versus Liberal positive end-expiratory pressure in patients without the Acute respiratory distress syndrome - the ‘RELAx’ trial Aim: Artificial ventilation with
‘positive end-expiratory pressure’ (PEEP) prevents atelectases. PEEP, however,
could also cause hyperinflation and hemodynamic compromise. While there is sufficient
evidence for benefit of PEEP in intensive care unit (ICU) patients with acute
respiratory distress syndrome (ARDS), evidence for benefit from PEEP in ICU patients
without ARDS is uncertain. In the Netherlands these patients are ventilated
with median 8 cmH2O PEEP
Design: National multicenter randomized controlled two-arm trial in The Netherlands Population: Intensive care unit patients without ARDS Status: Study has started Link to trial site: Description of study details Link to publication in TRIALS (rational and study design): not yet available Link to clinicaltrials.gov: not yet available Title: Assessment of Ventilatory mAnagemenT during generAl anesthesia for Robotic surgery Aim: To assess the incidence of postoperative pulmonary complications, dependence of postoperative pulmonary complications on intra-operative MV settings and to characterize current mechanical ventilation practices during general anesthesia for robotic surgery Design: International prospective observational 30-day cohort study Population: All patients undergoing general anesthesia for robotic surgery in the operating room Status: Study is running Link to trial site: not ready yet Link to publication (on rational and study design): not ready yet PROTHOR Title: PROtective VENTilation during THORAX surgery Aim: To determine whether a strategy with higher PEEP plus recruitment maneuvers improves clinical outcome in patients receiving one-lung ventilation Design: International multicenter double-blind randomized controlled two-arm trial Population: Patients planned for thoracic surgery with one-lung ventilation Status: Study protocol is ready Link to trial site: description of study details Link to clinicaltrials.gov: description of study details Email: prothor@peg-dresden.de Title: Extubation strategies in neuro-ICU patients and associations with outcomes (ENIO) Aim: To create a prediction score of extubation success in neuro-ICU patients, including patients with traumatic brain injury, subarachnoid hemorrhage, or stroke, and delineate the consequences on in-ICU and in-hospital outcomes. Design: International multi-centrer observational study Population: Neuro-ICU patients with a Glasgow Coma Score ≤ 12, with mechanical ventilation duration ≥ 24 hours, and extubation and/or tracheostomy. Trial site: non applicable Status: Recruitment of patients has started Link to clinicaltrials.gov: Description of study details E-mail: raphael.cinotti@chu-nantes.fr DESIGNATION Title: The Driving prEsSure durIng GeNeral AnesThesIa for abdOmiNal surgery (DESIGNATION) trial Aim: To test the hypothesis whether individualized high PEEP strategy, preventing an increase in the driving pressure during intraoperative ventilation, protects against postoperative pulmonary complications in patients with an increased risk who are subjected to scheduled open abdominal surgery Design: International multicenter randomized controlled trial Population: 1468 patients scheduled for open abdominal surgery with an increased risk of postoperative pulmonary complications Status: Recruitment of patients has started Link to trial site: not ready yet Link to clinicaltrials.gov: Description of study details Link to publication in TRIALS (rational and study design): not ready yet Email: designation@amc.nl FUTURE PROJECTS
PReSPON Title: Early PReserved SPONtaneous breathing activity in mechanically ventilated patients with acute respiratory distress syndrome Aim: To evaluate if preserved spontaneous breathing activity in the early phase improves mortality in mechanically ventilated patients with acute respiratory distress syndrome (ARDS). Design: International multicenter double-blind randomized controlled two-arm trial Population: Patients with moderate to severe ARDS Status: Study protocol is under development Link to trial site: follows Link to clinicaltrials.gov: follows Email: follows ICONIC Title: Conservative versus Conventional Oxygenation in ICU patients – the ICONIC trial Aim: To compare a ventilation strategy that uses conservative targets (PaO2 55-80 mmHg (7.3-10.7 kPa)) with one that uses conventional oxygenation targets (PaO2 110-150 mmHg (14.7-20 kPa)) for arterial oxygenation. Primary endpoint is all-cause mortality at 28 days after ICU-admission. Secondary endpoints include the number of days alive and free from ventilation at day 28 after admission to the ICU, hospital length-of-stay, SOFA score, and costs of hospitalization. Design: Multicenter randomized controlled two arm trial Population: 1,512 ICU patients with an anticipated duration of ventilation of at least 24 hours. Status: Study protocol under review of ethical board Link to trial site: not yet available Link to publication in TRIALS: not yet available Link to clinicaltrials.gov: not yet available Email: c.c.a.grim@lumc.nl METAANALYSES SYSTEMIC REVIEW ON THE EFFECTS OF VOLATILE ANESTHETICS IN PATIENTS UNDERGOING SURGERY Title: Effects of volatile anesthetics on mortality and postoperative pulmonary and extra-pulmonary complications in patients undergoing surgery: a systematic review and meta-analysis Aim: To compare the effects of use of volatile anesthetics during general anesthesia for surgery to total intravenous anesthesia in respect to mortality and incidence of postoperative pulmonary and extra pulmonary complications and EPPCs in a mixed surgical patient population
Design: Meta-analysis of randomized controlled trials comparing sevoflurane, desflurane, or isoflurane to intravenous anesthesia
Studies: Sixty-eight trials of protective mechanical ventilation including 7,104 patients undergoing general anesthesia for surgery Status: Meta-analysis is performed - manuscript is submitted Link to publication of study design: University of York - Centre for Reviews and Dissemination Link to publication in Anesthesiology: Anesthesiology 2016: 124:1230 ASSOCIATIONS BETWEEN DRIVING PRESSURE AMPLITUDES AND OCCURRENCE OF POSTOPERATIVE LUNG INJURY Title: Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome - meta-analysis using individual patient data
Aim: To determine the impact of tidal volumes and driving pressures on development of ARDS Design: Meta-analysis of studies and trials of protective mechanical ventilation in patients without ARDS Studies: Fifteen studies and trials of protective mechanical ventilation including 2,171 patients without ARDS Status: Meta-analysis is performed - manuscript is sumitted Link to publication in Systematic Review (protocol and study design): Syst Rev. 2014 Jan 2;3:2 Link to publication in Lancet RM: Lancet RM 2016 April; 4:272 VENTILATION IN PATIENTS UNDER ECMO Title: Association between tidal volume size, driving pressures and clinical outcomes among patients under ECMO Aim: To determine the impact of tidal volume size and driving pressures on outcome of patients under ECMO Design: Meta-analysis of studies and trials of mechanical ventilation in patients under ECMO Studies: Studies and trials of ECMO in patients with ARDS Status: Finished Publication in ICM: Intensive Care Medicine 2016 November; 42:1672 EVOLUTION OF VENTILATION IN OR AND ICU (eVENT) Title: Evolution of ventilator parameters during ventilation in the Intensive Care Unit setting and for general anesthesia in the Operation Room Aim: To determine changes in tidal volume settings, and to associate changes with outcomes Design: Meta-regression analysis of studies and trials reporting on mechanical ventilation in patients without ARDS Studies: Not yet available Status: Literature databases search is complete, analyses are performed Email: maximilian.schaefer@med.uni-duesseldorf.de & tanja.treschan@med.uni-duesseldorf.de Publication: Paper accepted for publication in A&A Link to publication in A&A: Not yet available ENDORSED PROJECTS INTUBE Title: INternational observational study To Understand the impact and BEst practices of airway management in critically ill patients (INTUBE) Aim: INTUBE project aims to prospectively collect data on the current impact of endotracheal intubation (ETI)–related adverse events and current airway management practice in critically ill patients. Design: INTUBE is a large multicenter, prospective, observational study on airway management in critically ill patients. Population: INTUBE will prospectively collect data for 1,000 ETI–related major complications from at least 180 centers worldwide. Each center is asked to collect data of 20 ETIs. Status: From 1 October to 31 March 2018, each center will select a start date for recruitment and data collection of 20 ETIs (with a maximum time window of 8 weeks for each center). Link to trial site: Description of study details Link to clinicaltrials.gov: Description of study details |
