Driving Pressure During General Anesthesia for Open Abdominal Surgery

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1,468 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,468

Conditions

Postoperative Respiratory Complication

Interventions

Individualized high PEEP strategyPROCEDURE

Patients are randomized and intra-operatively ventilated with an individualized high PEEP strategy (Highest PEEP with the lowest driving pressure with recruitment maneuvers)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (22)

University hospital Carl Gustav Carus

Dresden, Germany

Heinrich-Heine University Hospital Dusseldorf

Düsseldorf, Germany

Outcomes

Primary Outcomes

Proportion of participants developing one or more postoperative pulmonary complications (PPCs)

Severe respiratory failure; ARDS; Suspected pulmonary infection; Pulmonary infiltrate ; Pleural effusion; Atelectasis; Pneumothorax; Bronchospasm; Aspiration pneumonitis; Cardiopulmonary edema

Time frame: The first 5 postoperative days

Secondary Outcomes

Rate of mild respiratory failures

Defined as a PaO2 \< 60 mmHg (or \< 7.9 kPa) or SpO2 \< 90% in room air, but responding to supplemental oxygen (excluding hypoventilation)

Time frame: The first 5 postoperative days

Proportion of participants developing one or more post-operative extra-pulmonary complications

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 \[Mehta RL., et al., Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care, 2007\])

Time frame: The first 5 postoperative days

Rate of intra-operative complications

Time frame: For the length of the anesthesia, which will be estimated 2 to 5 hours.

The total amount and type of intraoperative fluid administration

Type of fluids: colloids, crystalloids or blood products

Time frame: For the length of the anesthesia, which will be estimated 2 to 5 hours

Rate of all-cause mortality and in-hospital mortality

Time frame: Postoperative day 5, day 30 and day 90

Data from ClinicalTrials.gov

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