Projects


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

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

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

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
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: B
urn 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

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
Link to publication in JAMA: JAMA 2018; in press


ONGOING PROJECTS

PROBESE
Title: PRotective ventilation of OBESE patients
Aim: 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 sitePROBESE trial site
Link to clinicaltrials.govDescription of study details
Link to publication in TRIALS (rational and study design): Trials 2017; 18:202

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 Trial
Aim: 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


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: P
atients 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

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

AVATaR

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 clinicaltrials.gov: description of study details
Link to publication (on rational and study design): not ready yet


FUTURE PROJECTS


PROTHORAX

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: Not yet available
Link to clinicaltrials.gov: Not yet available


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: Completed (10,500 patients were included) - analysis finished


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 under review


OTHER PROJECTS

The PROLUNG training network: for details click here