Driving Pressure During General Anesthesia for Open Abdominal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION) - a Randomized Clinical Trial

Conditions
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Postoperative Respiratory Complication

Intervention / Treatment
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* Procedure: Individualized high PEEP strategy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized high PEEP strategy<br>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. | Procedure: Individualized high PEEP strategy<br>* Patients are randomized and intra-operatively ventilated with an individualized high PEEP strategy (Highest PEEP with the lowest driving pressure with recruitment maneuvers)<br>|
| No Intervention: Standard low PEEP strategy<br>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) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The first 5 postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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]) | The first 5 postoperative days | 
| 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 | Type of fluids: colloids, crystalloids or blood products | For the length of the anesthesia, which will be estimated 2 to 5 hours | 
| Rate of all-cause mortality and in-hospital mortality |  | Postoperative day 5, day 30 and day 90 | 
| 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 | Visual inspection of the following: impairment of wound healing and/or wound infection; | The first 5 postoperative days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical ventilation, Positive end-expiratory pressure, Driving pressure, Post-operative postoperative complications, Open abdominal surgery, Recruitment maneuver, PEEP