Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1,806 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 Positive End Expiratory Pressure (PEEP) strategy with recruitment maneuvers, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of postoperative pulmonary complications in patients undergoing minimally invasive abdominal surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,806

Conditions

Postoperative Complications Surgery

Interventions

The intervention is intraoperative ventilation using the available ventilator with individualized high PEEP titrated to the lowest ΔP with RMs. After abdominal insufflation, patients randomized to the individualized high PEEP with RMs group will receive a RM followed by a 'decremental PEEP trial'. This is followed by a second RM after which PEEP is set at the level indicated by the decremental PEEP trial

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. age \> 18 years; AND 2. scheduled for minimally invasive abdominal surgery; AND 3. at increased (i.e., intermediate or high) risk of PPCs according to the 'Assess Respiratory risk in Surgical Patients in Catalonia' (ARISCAT) risk score (≥ 26 points, see Appendix I); OR at increased risk of PPCs based on the combination of age \> 40 years, scheduled surgery lasting \> 2 hours and planned to receive an intra-arterial catheter for blood pressure monitoring during the surgery; AND 4. signed written informed consent Exclusion criteria: 1. planned for open abdominal surgery; 2. planned for surgery in lateral or prone position; 3. planned for combined abdominal and intra-thoracic surgery 4. confirmed pregnancy; 5. consent for another interventional trial during anesthesia; 6. having received invasive ventilation \> 30 minutes within the last five days; 7. any previous lung surgery; 8. history of previous severe chronic obstructive pulmonary disease (COPD) with (noninvasive) ventilation or oxygen therapy at home or repeated systemic corticosteroid therapy for acute exacerbations of COPD; 9. history of acute respiratory distress syndrome (ARDS); 10. expected to require postoperative ventilation; 11. expected hemodynamic instability or intractable shock; 12. severe cardiac disease (New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmia's).

Outcomes

Primary Outcomes

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

A composite of the following pulmonary complications: mild respiratory failure; severe respiratory failure; bronchospasm; suspected pulmonary infection; pulmonary infiltrate; aspiration pneumonitis; atelectasis; acute respiratory distress syndrome (ARDS); pleural effusion; cardiopulmonary edema; pneumothorax

Time frame: The first 5 postoperative days

Secondary Outcomes

Intraoperative complications

Including: any episode of desaturation; any episode of hypotension; any need for vasoactive agents, either as bolus or continuous administration, defined as more than needed to compensate for vasodilating effects of anesthesia as judged by the attending anesthesiologist and any new arrhythmias needing intervention

Time frame: For the duration of general anesthesia, these outcomes are scored every hour up to a maximum of 18 hours

Intraoperative fluid strategy

Including the total amount of fluids administered during anesthesia, including the amounts of colloids, crystalloids, and blood products

Time frame: During general anesthesia

Impaired wound healing

Impaired wound healing, as judged and mentioned in the medical record by the attending ward physician;

Time frame: The first 5 postoperative days

Postoperative extrapulmonary complications

Including: sepsis; septic shock; extrapulmonary infection; anastomotic leak and acute renal failure

Time frame: The first 5 postoperative days

Mortality

All-cause mortality at day 5, day 30 and 90, and in-hospital mortality

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

Length of stay

Length of hospital stay (days); length of ICU admission if applicable (days);

Time frame: Postoperatively until the end of the 90 day follow-up period

Oxygen use

Postoperative supplemental oxygen use (days). Presence, duration and levels of postoperative supplemental oxygen

Time frame: The first 5 postoperative days

Antibiotics use

Use of antibiotics for pneumonia (proportion of patients who received antibiotics)

Time frame: The first 5 postoperative days

Thoracic imaging

Occurence of imaging (chest X-ray, computed tomography scan). Proportion of patients who underwent thoracic imaging.

Time frame: The first 5 postoperative days

Central Contacts

Tom Vermeulen, MD

CONTACT

+ 31 020 566 2533 t.d.vermeulen@amsterdamumc.nl

Galina Dorland, MD

CONTACT

g.dorland@amsterdamumc.nl

Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts