Projects

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

Title: Association between pre-operative biological phenotypes and postoperative pulmonary complications: An unbiased cluster analysis

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

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

Email: tanja.treschan@med.uni-duesseldorf.de

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

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 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 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 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

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

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

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

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

ENIO

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: Centers are recruited

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 surgeryDesign: International multicenter randomized controlled trial

Population: 1468 patients scheduled for open abdominal surgery with an increased risk of postoperative pulmonary complicationsStatus: Centers are recruited; study protocol is being written

Link to trial site: not ready yet

Link to clinicaltrials.gov: not ready yet

Link to publication in TRIALS (rational and study design): not ready yet

Email: not ready yet

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

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

ASSOCIATIONS BETWEEN DRIVING PRESSURE AMPLITUDES AND OCCURRENCE OF POSTOPERATIVE LUNG INJURY

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

PROLUNG

The PROLUNG training network: for details click here