Driving pressure during general anesthesia for minimally invasive abdominal surgery - a randomized clinical trial

Recruiting

• Conditions: lung complications after surgery; 10038716; Postoperative pulmonary complications

• Registration Number: NL-OMON56378
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 1445

Inclusion Criteria

In order to be eligible to participate in this trial, a patient must meet the
following criteria:
1. age above 18 years;
2. scheduled for minimally invasive abdominal surgery; AND
3. increased (i.e., intermediate or high) risk of PPCs according to the ARISCAT
risk score (26 or more points); OR
4. the combination of age above 40 years, scheduled surgery lasting more than 2
hours and planned to receive an intra-arterial catheter for blood pressure
monitoring during the surgery;
5. signed written informed consent

Exclusion Criteria

A potential patient who meets any of the following criteria will be excluded
from participation in this trial: 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is a composite of PPCs in the first 5 postoperative days<br /><br>- Mild respiratory failure<br /><br>- Severe respiratory failure<br /><br>- Bronchospasm<br /><br>- Pneumonia<br /><br>- Aspiration pneumonitis<br /><br>- Atelectasis<br /><br>- Acute respiratory distress syndrome (ARDS)<br /><br>- Pleural effusion<br /><br>- Cardiopulmonary edema<br /><br>- Pneumothorax</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Intraoperative complications including:<br /><br>- Desaturation<br /><br>- Hypotension<br /><br>- Increased need for vasoactive medications<br /><br>- New arrhytmias needing intervention<br /><br>Impaired wound healing<br /><br>Postoperative extrapulmonary complications<br /><br>- Sepsis<br /><br>- Septic shock<br /><br>- Extra-pulmonary infection<br /><br>- Acute renal insufficiency<br /><br>Impaired wound healing<br /><br>Intra-operative fluid strategy<br /><br>All cause mortality at day 5, 30 and 90<br /><br>Cost-effectiveness variables<br /><br>- Postoperative supplementary oxygen need<br /><br>- Use of antibiotics for pneumonia<br /><br>- Need for thoracic imaging<br /><br>- Length of hospital stay<br /><br>- Need of ICU admission and corresponding lenth of ICU stay<br /><br><br /><br>- Unplanned admission to an intenvise care unit (ICU) and lenght of stay on ICU<br /><br>- Length of hospital stay</p><br>