Postoperative ComplicationsGENERATORNCT06101511
Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR)
A study testing Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs in people with Postoperative Complications and Surgery, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Postoperative Complications, Surgery
- What is being tested?
- Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,806 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Dec 2023to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Galina Dorland, MD contact
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam University Medical Center
Amsterdam, Noordholland, 1105AZ
Tom Vermeulen, Master, t.d.vermeulen@amsterdamumc.nl
About this study
Official title: Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR) - a Randomized Clinical Trial
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.
- Conditions
- Postoperative Complications, Surgery
- Being tested
- Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs
- Keywords
- Minimally invasive abdominal surgery, Mechanical ventilation, Positive end-expiratory pressure, Driving pressure, Postoperative pulmonary complications, Recruitment maneuver
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMsProcedure or surgery
Also called Individualized high PEEP strategy with recruitment maneuvers
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
| Study group | Role | What they receive |
|---|---|---|
| Individualized high PEEP strategy with recruitment maneuvers | Experimental | The intervention is intraoperative ventilation using the available ventilator with individualized high positive end-expiratory pressure (PEEP) titrated to the lowest driving pressure (ΔP) with recruitment maneuvers (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. Receives: Procedure: Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs |
| Standard low PEEP strategy without recruitment maneuvers | No intervention | Patients randomized to the standard low PEEP group will receive 5 cm H2O PEEP for the complete duration of general anesthesia. They will neither receive one of the planned RMs nor a decremental PEEP trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The first 5 postoperative days
Secondary outcomes (9)
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
Measured: 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
Measured: During general anesthesia
Impaired wound healing
Impaired wound healing, as judged and mentioned in the medical record by the attending ward physician;
Measured: The first 5 postoperative days
Postoperative extrapulmonary complications
Including: sepsis; septic shock; extrapulmonary infection; anastomotic leak and acute renal failure
Measured: The first 5 postoperative days
Mortality
All-cause mortality at day 5, day 30 and 90, and in-hospital mortality
Measured: Postoperative day 5, day 30 and day 90
Length of stay
Length of hospital stay (days); length of ICU admission if applicable (days);
Measured: 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
Measured: The first 5 postoperative days
Antibiotics use
Use of antibiotics for pneumonia (proportion of patients who received antibiotics)
Measured: The first 5 postoperative days
Thoracic imaging
Occurence of imaging (chest X-ray, computed tomography scan). Proportion of patients who underwent thoracic imaging.
Measured: The first 5 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start11 Dec 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,806 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Onze Lieve Vrouwe Gasthuis, HagaZiekenhuis, Dijklander Ziekenhuis, The Netherlands Cancer Institute, Isala, Maasstad Hospital, Medisch Spectrum Twente, University Medical Center Groningen, Leiden University Medical Center, Hospital Universitario La Fe, Ospedale Policlinico San Martino, University Hospital Carl Gustav Carus, Medical University Innsbruck, Spaarne Gasthuis, Zaans Medical Center, Alrijne Hospital, Albert Schweitzer Hospital, Maastricht University Medical Center, Noordwest Ziekenhuisgroep
- Responsible party
- Principal investigator, Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Marcus Schultz, Professor, Study chair, Amsterdam University Medical Center, location AMCMarkus Hollmann, Professor, Principal investigator, Amsterdam University Medical Center, location AMCDavid van Meenen, PhD, Principal investigator, Amsterdam University Medical Center, location AMCSabrine Hemmes, PhD, Principal investigator, Amsterdam University Medical Center, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101511
- Sponsor's protocol ID
- NL82971.018.23
- Acronym
- GENERATOR
- Status last verified
- Jan 2025
- First submitted
- 19 Jul 2023
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Interested researchers can contact the Principal Investigator for a collaboration after which an agreement will be discussed.
Publications
GENERATOR-investigators. Driving pressure during general anesthesia for minimally invasive abdominal surgery (GENERATOR)-study protocol of a randomized clinical trial. Trials. 2024 Oct 26;25(1):719. doi: 10.1186/s13063-024-08479-x.
PubMed 39456048
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR) - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06101511
- Acronym / sponsor ID
- GENERATOR / NL82971.018.23
- Conditions
- Postoperative Complications, Surgery
- Keywords
- Minimally invasive abdominal surgery, Mechanical ventilation, Positive end-expiratory pressure, Driving pressure, Postoperative pulmonary complications, Recruitment maneuver
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,806 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Onze Lieve Vrouwe Gasthuis, HagaZiekenhuis, Dijklander Ziekenhuis, The Netherlands Cancer Institute, Isala, Maasstad Hospital, Medisch Spectrum Twente, University Medical Center Groningen, Leiden University Medical Center, Hospital Universitario La Fe, Ospedale Policlinico San Martino, University Hospital Carl Gustav Carus, Medical University Innsbruck, Spaarne Gasthuis, Zaans Medical Center, Alrijne Hospital, Albert Schweitzer Hospital, Maastricht University Medical Center, Noordwest Ziekenhuisgroep
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized high PEEP strategy with recruitment maneuvers | Experimental | Procedure: Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMsThe intervention is intraoperative ventilation using the available ventilator with individualized high positive end-expiratory pressure (PEEP) titrated to the lowest driving pressure (ΔP) with recruitment maneuvers (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. |
| Standard low PEEP strategy without recruitment maneuvers | No intervention | –Patients randomized to the standard low PEEP group will receive 5 cm H2O PEEP for the complete duration of general anesthesia. They will neither receive one of the planned RMs nor a decremental PEEP trial. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMsAlso: Individualized high PEEP strategy with recruitment maneuversThe 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 | Procedure or surgery | Individualized high PEEP strategy with recruitment maneuvers |
Primary outcome
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
9 secondary outcomes
Intraoperative complications
Time frame: For the duration of general anesthesia, these outcomes are scored every hour up to a maximum of 18 hours
Intraoperative fluid strategy
Time frame: During general anesthesia
Impaired wound healing
Time frame: The first 5 postoperative days
Postoperative extrapulmonary complications
Time frame: The first 5 postoperative days
Mortality
Time frame: Postoperative day 5, day 30 and day 90
Length of stay
Time frame: Postoperatively until the end of the 90 day follow-up period
Oxygen use
Time frame: The first 5 postoperative days
Antibiotics use
Time frame: The first 5 postoperative days
Thoracic imaging
Time frame: The first 5 postoperative days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Derived from this study: PubMed 39456048GENERATOR-investigators. Driving pressure during general anesthesia for minimally invasive abdominal surgery (GENERATOR)-study protocol of a randomized clinical trial. Trials. 2024 Oct 26;25(1):719. doi: 10.1186/s13063-024-08479-x.
- Individual participant dataSharing planned: Yes. Interested researchers can contact the Principal Investigator for a collaboration after which an agreement will be discussed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Galina Dorland, MD contact
Marcus Schultz, Professor study chair
Amsterdam University Medical Center, location AMC
Markus Hollmann, Professor principal investigator
Amsterdam University Medical Center, location AMC
David van Meenen, PhD principal investigator
Amsterdam University Medical Center, location AMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs in people with Postoperative Complications and Surgery, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tom Vermeulen, MD (+ 31 020 566 2533, t.d.vermeulen@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants developing one or more postoperative pulmonary complications (PPCs) (time frame: The first 5 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06101511, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.