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NCT Number: NCT06101511

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

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.

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Key information

Conditions

Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Surgery

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam University Medical Center

Amsterdam, Noordholland, 1105AZ, Netherlands

Location status: Recruiting

Location contact

Tom Vermeulen, Master

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18 years; AND
  • scheduled for minimally invasive abdominal surgery; AND
  • 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
  • signed written informed consent

Exclusion criteria

  • planned for open abdominal surgery;
  • planned for surgery in lateral or prone position;
  • planned for combined abdominal and intra-thoracic surgery
  • confirmed pregnancy;
  • consent for another interventional trial during anesthesia;
  • having received invasive ventilation > 30 minutes within the last five days;
  • any previous lung surgery;
  • 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;
  • history of acute respiratory distress syndrome (ARDS);
  • expected to require postoperative ventilation;
  • expected hemodynamic instability or intractable shock;
  • severe cardiac disease (New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmia's).

Treatment and study plan

Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs

Procedure

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

Other names: Individualized high PEEP strategy with recruitment maneuvers

Primary outcomes

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

    Time frame: The first 5 postoperative days

    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

Secondary outcomes

  1. Intraoperative complications

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

    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

  2. Intraoperative fluid strategy

    Time frame: During general anesthesia

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

  3. Impaired wound healing

    Time frame: The first 5 postoperative days

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

  4. Postoperative extrapulmonary complications

    Time frame: The first 5 postoperative days

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

  5. Mortality

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

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

  6. Length of stay

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

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

  7. Oxygen use

    Time frame: The first 5 postoperative days

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

  8. Antibiotics use

    Time frame: The first 5 postoperative days

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

  9. Thoracic imaging

    Time frame: The first 5 postoperative days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Galina Dorland, MD

CONTACT

[email protected]

Tom Vermeulen, MD

CONTACT

[email protected]

+ 31 020 566 2533

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Albert Schweitzer Hospital
  • Alrijne Hospital
  • Dijklander Ziekenhuis
  • HagaZiekenhuis
  • Hospital Universitario La Fe
  • Isala
  • Leiden University Medical Center
  • Maasstad Hospital
  • Maastricht University Medical Center
  • Medical University Innsbruck
  • Medisch Spectrum Twente
  • Noordwest Ziekenhuisgroep
  • Onze Lieve Vrouwe Gasthuis
  • Ospedale Policlinico San Martino
  • Spaarne Gasthuis
  • The Netherlands Cancer Institute
  • University Hospital Carl Gustav Carus
  • University Medical Center Groningen
  • Zaans Medical Center

Registry information

Official study title

Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR) - a Randomized Clinical Trial

Acronym: GENERATOR

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 26, 2023
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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