Clinical trial NCT03884543: Driving Pressure During General Anesthesia for Open Abdominal Surgery
Official title: Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION) - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postoperative Respiratory Complication
Keywords: Mechanical ventilation
Positive end-expiratory pressure
Driving pressure
Post-operative postoperative complications
Open abdominal surgery
Recruitment maneuver
PEEP
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC, location VUmc
name: Noord West Ziekenhuizen location Alkmaar
name: University Medical Center Groningen
name: Radboud University Medical Center
name: HagaZiekenhuis
name: Rijnstate Hospital
name: Medical Center Haaglanden
name: Bernhoven Hospital
name: Onze Lieve Vrouwe Gasthuis
name: Albert Schweitzer Hospital
name: Frisius Medisch Centrum
name: Leiden University Medical Center
name: Maastricht University Medical Center
name: Martini Hospital Groningen
name: Erasmus Medical Center
name: Spaarne Gasthuis
name: University Hospital Carl Gustav Carus
name: Bermanntrost BG Klinikum Halle
name: Heinrich-Heine University, Duesseldorf
name: Ospedale Policlinico San Martino
name: Jeroen Bosch Ziekenhuis
name: Meander Medical Center
name: Isala
name: Alrijne Hospital
name: Antoni van Leeuwenhoek Ziekenhuis
name: Medisch Spectrum Twente
name: Campus Bio-Medico University
name: Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
name: University of Roma La Sapienza
name: University of Campania Luigi Vanvitelli
name: Hospital Universitario La Fe
name: Medical University Innsbruck
First posted: 2019-03-21
Enrollment: 1468
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this international multicenter, patient and outcome-assessor blinded randomized controlled trial is to determine whether the application of an individualized high PEEP strategy, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of postoperative pulmonary complications.


Eligibility criteria: Inclusion Criteria:

* Scheduled for open abdominal surgery
* High or intermediate risk for postoperative pulmonary complications according to ARISCAT score \[J.Canet et al, Anesthesiology 2010;113\]
* General anesthesia

Exclusion Criteria:

* Laparoscopic surgery
* Surgery in prone or lateral position
* Combined procedure with open abdominal and intrathoracic surgery
* Body mass index \> 40 kg/m2;
* Reported pregnancy;
* Mechanical ventilation \> than 30 minutes (e.g., in cases of general anesthesia because of surgery) within last 30 days;
* Any major previous lung surgery;
* History of previous severe chronic obstructive pulmonary disease (COPD) GOLD III or IV, or with (noninvasive) ventilation and/or oxygen therapy at home;
* (previous) acute respiratory distress syndrome (ARDS);
* Expected to require postoperative mechanical ventilation;
* Persistent hemodynamic instability or intractable shock;
* Severe cardiac disease (New York Heart Association class III or IV, or acute coronary syndrome, or persistent ventricular tachyarrhythmia's);
* Consented for another interventional study during anesthesia or refusal to participate in the study

Primary outcomes:
measure: Proportion of participants developing one or more postoperative pulmonary complications (PPCs)
timeFrame: The first 5 postoperative days
Secondary outcomes:
measure: Rate of mild respiratory failures
timeFrame: The first 5 postoperative days
measure: Proportion of participants developing one or more post-operative extra-pulmonary complications
timeFrame: The first 5 postoperative days
measure: Rate of intra-operative complications
timeFrame: For the length of the anesthesia, which will be estimated 2 to 5 hours.
measure: The total amount and type of intraoperative fluid administration
timeFrame: For the length of the anesthesia, which will be estimated 2 to 5 hours
measure: Rate of all-cause mortality and in-hospital mortality
timeFrame: Postoperative day 5, day 30 and day 90
measure: Length of hospital stay
timeFrame: From the day of surgery until the day of discharge, up to day 90
measure: Number of participants with an unscheduled Intensive Care Unit (ICU) (re-) admission and length of stay in Intensive care unit
timeFrame: From the day of surgery until the day of discharged, up to day 90
measure: Assessment of postoperative wound healing
timeFrame: The first 5 postoperative days
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University hospital Carl Gustav Carus
city: Dusseldorf
country: Germany
facility: Heinrich-Heine University Hospital Dusseldorf
city: Halle
country: Germany
facility: Bermanntrost BG Klinikum Halle
city: Genua
country: Italy
facility: Ospedale Policlinico San Martino
city: Napoli
country: Italy
facility: University hospital Napoli
city: Alkmaar
country: Netherlands
facility: Noordwest ziekenhuizengroep Alkmaar
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC location VUmc
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwen Gasthuis
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Den Haag
country: Netherlands
facility: Haaglanden Medisch Centrum
city: Den Haag
country: Netherlands
facility: HAGA
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Groningen
country: Netherlands
facility: Martini Hospital
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis Hospital
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
city: Leiden
country: Netherlands
facility: Leiden UMC
city: Maastricht
country: Netherlands
facility: Maastricht UMC
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Uden
country: Netherlands
facility: Bernhoven Hospital
Study officials:
affiliation: Department of Intensive Care
name: Marcus J. Schultz, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology
name: Markus W. Hollmann, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.
citation: DESIGNATION-investigators. Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION): study protocol of a randomized clinical trial. Trials. 2020 Feb 18;21(1):198. doi: 10.1186/s13063-020-4075-z.