Postoperative Respiratory Complication
Conditions
Keywords
Mechanical ventilation, Positive end-expiratory pressure, Driving pressure, Post-operative postoperative complications, Open abdominal surgery, Recruitment maneuver, PEEP
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.
Interventions
PROCEDUREIndividualized high PEEP strategy
Patients are randomized and intra-operatively ventilated with an individualized high PEEP strategy (Highest PEEP with the lowest driving pressure with recruitment maneuvers)
Sponsors
Amsterdam UMC, location VUmc
Noord West Ziekenhuizen location Alkmaar
University Medical Center Groningen
Radboud University Medical Center
HagaZiekenhuis
Rijnstate Hospital
Medical Center Haaglanden
Bernhoven Hospital
Onze Lieve Vrouwe Gasthuis
Albert Schweitzer Hospital
Frisius Medisch Centrum
Leiden University Medical Center
Maastricht University Medical Center
Martini Hospital Groningen
Erasmus Medical Center
Spaarne Gasthuis
University Hospital Carl Gustav Carus
Bermanntrost BG Klinikum Halle
Heinrich-Heine University, Duesseldorf
Ospedale Policlinico San Martino
Jeroen Bosch Ziekenhuis
Meander Medical Center
Isala
Alrijne Hospital
Antoni van Leeuwenhoek Ziekenhuis
Medisch Spectrum Twente
Campus Bio-Medico University
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
University of Roma La Sapienza
University of Campania Luigi Vanvitelli
Hospital Universitario La Fe
Medical University Innsbruck
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants developing one or more postoperative pulmonary complications (PPCs) | The first 5 postoperative days | Severe respiratory failure; ARDS; Suspected pulmonary infection; Pulmonary infiltrate ; Pleural effusion; Atelectasis; Pneumothorax; Bronchospasm; Aspiration pneumonitis; Cardiopulmonary edema |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants developing one or more post-operative extra-pulmonary complications | The first 5 postoperative days | Including sepsis (according to the SEPSIS-3 definition), septic shock (defined as sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥ 65mmHg and having a serum lactate level \>2 mmol/L despite adequate volume resuscitation), extra-pulmonary infection (including wound infection and any other infection), anastomic leak and acute renal failure (as defined by AKIN \[Mehta RL., et al., Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care, 2007\]) |
| Rate of intra-operative complications | For the length of the anesthesia, which will be estimated 2 to 5 hours. | — |
| The total amount and type of intraoperative fluid administration | For the length of the anesthesia, which will be estimated 2 to 5 hours | Type of fluids: colloids, crystalloids or blood products |
| Rate of mild respiratory failures | The first 5 postoperative days | Defined as a PaO2 \< 60 mmHg (or \< 7.9 kPa) or SpO2 \< 90% in room air, but responding to supplemental oxygen (excluding hypoventilation) |
| Length of hospital stay | From the day of surgery until the day of discharge, up to day 90 | — |
| Number of participants with an unscheduled Intensive Care Unit (ICU) (re-) admission and length of stay in Intensive care unit | From the day of surgery until the day of discharged, up to day 90 | — |
| Assessment of postoperative wound healing | The first 5 postoperative days | Visual inspection of the following: impairment of wound healing and/or wound infection; |
| Rate of all-cause mortality and in-hospital mortality | Postoperative day 5, day 30 and day 90 | — |
Countries
Germany, Italy, Netherlands
Outcome results
None listed