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| Name | Class |
|---|---|
| Onze Lieve Vrouwe Gasthuis | OTHER |
| HagaZiekenhuis | OTHER |
| Dijklander Ziekenhuis | OTHER |
| The Netherlands Cancer Institute |
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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 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The first 5 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | For the duration of general anesthesia, these outcomes are scored every hour up to a maximum of 18 hours |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tom Vermeulen, MD | Contact | + 31 020 566 2533 | t.d.vermeulen@amsterdamumc.nl | |
| Galina Dorland, MD | Contact | g.dorland@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Marcus Schultz, Professor | Amsterdam University Medical Center, location AMC | Study Chair |
| Markus Hollmann, Professor | Amsterdam University Medical Center, location AMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam University Medical Center | Recruiting | Amsterdam | Noordholland | 1105AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39456048 | Derived | 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. |
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Interested researchers can contact the Principal Investigator for a collaboration after which an agreement will be discussed.
After the main paper has been published. No end-date has been specified for now.
The applicable researcher can contact the Principal investigator with their idea of using the data, preferably accompanied by a statistical analysis plan
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| OTHER |
| Isala | OTHER |
| Maasstad Hospital | OTHER |
| Medisch Spectrum Twente | OTHER |
| University Medical Center Groningen | OTHER |
| Leiden University Medical Center | OTHER |
| Hospital Universitario La Fe | OTHER |
| Ospedale Policlinico San Martino | OTHER |
| University Hospital Carl Gustav Carus | OTHER |
| Medical University Innsbruck | OTHER |
| Spaarne Gasthuis | OTHER |
| Zaans Medical Center | UNKNOWN |
| Alrijne Hospital | OTHER |
| Albert Schweitzer Hospital | OTHER |
| Maastricht University Medical Center | OTHER |
| Noordwest Ziekenhuisgroep | OTHER |
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| Intraoperative fluid strategy | Including the total amount of fluids administered during anesthesia, including the amounts of colloids, crystalloids, and blood products | During general anesthesia |
| Impaired wound healing | Impaired wound healing, as judged and mentioned in the medical record by the attending ward physician; | The first 5 postoperative days |
| Postoperative extrapulmonary complications | Including: sepsis; septic shock; extrapulmonary infection; anastomotic leak and acute renal failure | The first 5 postoperative days |
| Mortality | All-cause mortality at day 5, day 30 and 90, and in-hospital mortality | Postoperative day 5, day 30 and day 90 |
| Length of stay | Length of hospital stay (days); length of ICU admission if applicable (days); | 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 | The first 5 postoperative days |
| Antibiotics use | Use of antibiotics for pneumonia (proportion of patients who received antibiotics) | The first 5 postoperative days |
| Thoracic imaging | Occurence of imaging (chest X-ray, computed tomography scan). Proportion of patients who underwent thoracic imaging. | The first 5 postoperative days |
| David van Meenen, PhD | Amsterdam University Medical Center, location AMC | Principal Investigator |
| Sabrine Hemmes, PhD | Amsterdam University Medical Center, location AMC | Principal Investigator |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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