Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Active, not recruiting

Conditions: Postoperative Respiratory Complication

Treatments: Procedure: Individualized high PEEP strategy

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT03884543

DESIGNATION

Details and patient eligibility

About

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.

Enrollment: 1,468 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,468 participants in 2 patient groups

Individualized high PEEP strategy

Experimental group

Description:

Recruitment maneuver (performed after induction of anesthesia, after any disconnection from the mechanical ventilator, and before extubation) followed by the decremental PEEP trial to determine the highest level of PEEP resulting in the lowest driving pressure. This is again followed by a recruitment maneuver, after which PEEP is set at the level indicated by the decremental PEEP trial.

Treatment:

Procedure: Individualized high PEEP strategy

Standard low PEEP strategy

No Intervention group

Description:

PEEP at maximum 5cm H2O. No recruitment maneuvers. Patients are randomized and intraoperatively ventilated with conventional strategy. (PEEP at maximum 5cm H2O without recruitment maneuvers)