Protective Ventilation During General Anesthesia for Open Abdominal Surgery - a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 900
- Locations
- 32
- Primary Endpoint
- Post-operative pulmonary complications (PPCs)
Study Overview
Brief Summary
The purpose of this international, multicentre, double-blinded randomized controlled trial is to determine if the "open lung approach" providing recruitment maneuvers and PEEP(Positive End Expiratory Pressure) during general anesthesia reduces atelectasis formation and improves respiratory function in the immediate post-operative period after major abdominal surgery.
Participating centres throughout the world will include a total of 900 adult patients undergoing general anesthesia for open abdominal surgery with high or intermediate risk for post-operative pulmonary complications. Patients are randomized and intra-operatively ventilated with either a lung protective strategy (PEEP at 12 cmH2O with recruitment maneuvers) or a conventional strategy (PEEP at maximum 2 cmH2O without recruitment maneuvers). Patients will be assessed on the first 5 post-operative days, on day of discharge and on day 90 post-operative. Primary endpoint is any post-operative pulmonary complication (see below). Secondary endpoints are post-operative extra-pulmonary complications, intra-operative mechanical ventilation related complications, unscheduled ICU (Intensive Care Unit) (re-) admission, and length of hospital stay.
Detailed Description
Research questions
- Does mechanical ventilation with the use of higher levels of PEEP(Positive End Expiratory Pressure) and intra-operative RMs (Recruitment maneuvers) protect against pulmonary complications in patients at high or intermediate risk for postoperative pulmonary complications scheduled for non-laparoscopic abdominal surgery?
- Does mechanical ventilation with the use of higher levels of PEEP and intra-operative RMs protect against extra-pulmonary complications in patients at high or intermediate risk for postoperative pulmonary complications scheduled for non-laparoscopic abdominal surgery?
- Does mechanical ventilation with the use of higher levels of PEEP and intra-operative RMs shorten length of hospital stay of patients at high or intermediate risk for postoperative pulmonary complications scheduled for non-laparoscopic abdominal surgery?
- Does mechanical ventilation with the use of higher levels of PEEP and intra-operative RMs ameliorate post-operative wound healing in patients at high or intermediate risk for postoperative pulmonary complications scheduled for non-laparoscopic abdominal surgery?
- Does mechanical ventilation with the use of higher levels of PEEP and intra-operative RMs attenuate post-operative unexpected need for ICU admission (i.e., before surgery the patient is not scheduled for admission to the ICU, but eventually is admitted) or ICU readmission in patients at high or intermediate risk for postoperative pulmonary complications scheduled for non-laparoscopic abdominal surgery?
- Does mechanical ventilation with the use of higher levels of PEEP and intra-operative RMs influence intra-operative complications related to the ventilator strategy (i.e., de-saturation, hypotension during recruitment, need for vasopressors) or ICU readmission in patients at high or intermediate risk for postoperative pulmonary complications scheduled for non-laparoscopic abdominal surgery?
Methods In this international randomized controlled trial all patients with high or intermediate risk for post-operative pulmonary complications following non-laparoscopic abdominal surgery with general anesthesia are eligible for participation. To identify such patients the ARISCAT risk score is used.
Patients are randomly assigned to mechanical ventilation with levels of PEEP at 12 cmH2O with the use of recruitment maneuvers (the lung-protective strategy) or mechanical ventilation with levels of PEEP at maximum 2 cmH2O without recruitment maneuvers (the conventional strategy).
Patients are ventilated with a volume-controlled mechanical ventilation strategy. Although it is left to the discretion of the attending anesthesiologist to use different fractions of inspired oxygen, it is advised to use at least 0.4, with the lowest oxygen fraction to maintain oxygen saturation ≥ 92%. The I:E ratio is set at 1:2, and the respiratory rate is adjusted to reach normocapnia (etCO2 between 35 and 45 mmHg). Tidal volumes of < 8 mL/kg predicted body weight (PBW) are advised to be used.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Open abdominal surgery
- •General anesthesia
- •High or intermediate risk for postoperative pulmonary complications according to ARISCAT score [J.Canet et al, Anesthesiology 2010;113]
Exclusion Criteria
- •Age > 18 years
- •Body mass index > 40 kg/m2
- •Laparoscopic surgery
- •Previous lung surgery (any)
- •Persistent hemodynamic instability, intractable shock (considered hemodynamic unsuitable for the study by the patient's managing physician)
- •History of previous severe chronic obstructive pulmonary disease (COPD) (non-invasive ventilation and/or oxygen therapy at home, repeated systemic corticosteroid therapy for acute exacerbations of COPD)
- •Recent immunosuppressive medication (receiving chemotherapy or radiation therapy within last 2 months)
- •Severe cardiac disease (New York Heart Association class III or IV, or acute coronary syndrome, or persistent ventricular tachyarrhythmia's)
- •Mechanical ventilation > than 30 minutes (e.g., in cases of general anesthesia because of surgery) within last 30 days
- •Pregnancy (excluded by laboratory analysis)
- •Acute lung injury or acute respiratory distress syndrome expected to require prolonged postoperative mechanical ventilation
- •Neuromuscular disease (any)
- •Consented for another interventional study or refusal to participate in the study
Outcomes
Primary Outcomes
Post-operative pulmonary complications (PPCs)
Time Frame: first 5 days post-operative and on the day of discharge a final assessment is performed scoring endpoints occuring on day 6 and up.
Mild respiratory failure Severe respiratory failure ALI/ARDS (Acute Lung Injury and Acute Respiratory Distress Syndrome) Suspected pulmonary infection Pulmonary infiltrate Pleural effusion Atelectasis Pneumothorax Bronchospasm Aspiration pneumonitis Cardiopulmonary edema
Secondary Outcomes
- Post-operative extra-pulmonary complications(first 5 days post-operative and on the day of discharge a final assessment is performed scoring endpoints occuring on day 6 and up)
- Intra-operative mechanical ventilation related complications(during the length of anesthesia, which will be an estimated 2 to 5 hours)
- Unscheduled Intensive Care Unit (ICU) (re-) admission(first 5 days post-operative and on the day of discharge a final assessment is performed scoring endpoints occuring on day 6 and up)
- Length of hospital stay on day 90(until day 90 post-operative)
Investigators
Prof. Dr. Marcus J. Schultz
Principal Investigator and Clinical Professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)