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

Surgery Clinical Trial

— GENERATOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06101511
• Other study ID #: NL82971.018.23
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2023
• Est. completion date: September 1, 2027

Study information

• Verified date: January 2024
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Tom Vermeulen, MD
• Phone: + 31 020 566 2533
• Email: t.d.vermeulen[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 intraoperative ventilation, protects against the development of postoperative pulmonary complications in patients undergoing minimally invasive abdominal surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1806
• Est. completion date: September 1, 2027
• Est. primary completion date: June 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Postoperative Complications
• Surgery

Intervention

Procedure:
• Intraoperative ventilation with individualized high PEEP titrated to the lowest ?P with RMs
The intervention is intraoperative ventilation using the available ventilator with individualized high PEEP titrated to the lowest ?P 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

Locations

Country	Name	City	State
Netherlands	Amsterdam University Medical Center	Amsterdam	Noordholland

Sponsors (20)

Lead Sponsor

Collaborator

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

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

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Intraoperative fluid strategy	Including the total amount of fluids administered during anesthesia, including the amounts of colloids, crystalloids, and blood products	During general anesthesia
Secondary	Impaired wound healing	Impaired wound healing, as judged and mentioned in the medical record by the attending ward physician;	The first 5 postoperative days
Secondary	Postoperative extrapulmonary complications	Including: sepsis; septic shock; extrapulmonary infection; anastomotic leak and acute renal failure	The first 5 postoperative days
Secondary	Mortality	All-cause mortality at day 5, day 30 and 90, and in-hospital mortality	Postoperative day 5, day 30 and day 90
Secondary	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
Secondary	Oxygen use	Postoperative supplemental oxygen use (days). Presence, duration and levels of postoperative supplemental oxygen	The first 5 postoperative days
Secondary	Antibiotics use	Use of antibiotics for pneumonia (proportion of patients who received antibiotics)	The first 5 postoperative days
Secondary	Thoracic imaging	Occurence of imaging (chest X-ray, computed tomography scan). Proportion of patients who underwent thoracic imaging.	The first 5 postoperative days