Driving pressure during general anesthesia for open abdominal surgery - a randomized controlled trial

Recruiting

• Conditions: Postoperative pulmonary complications; 10038716

• Registration Number: NL-OMON55943
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 1250

Inclusion Criteria

Increased (i.e., intermediate or high) risk of postoperative pulmonary
complications (according to the ARISCAT risk score [>= 26] , Scheduled for open
abdominal surgery in one of the participating centers

Exclusion Criteria

Planned for laparoscopic surgery;
Planned for surgery in prone or lateral position;
Planned combined procedure with open abdominal and intrathoracic surgery;
Age < 18 years;
Body mass index > 40 kg/m2;
Reported pregnancy;
Having received mechanical ventilation for longer than 30 minutes (e.g.,
because of general anesthesia for surgery) within last 30 days;
Any major previous lung surgery;
History of previous severe chronic obstructive pulmonary disease (COPD) GOLD
III or IV, or with (noninvasive) ventilation and/or oxygen therapy at home;
(previous) acute respiratory distress syndrome (ARDS);
Expected to require postoperative mechanical ventilation;
Persistent hemodynamic instability or intractable shock;
Severe cardiac disease (New York Heart Association class III or IV, or acute
coronary syndrome, or persistent ventricular tachyarrhythmia*s);
Consent for another interventional study in anesthesiology; or
No written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is a composite of PPCs in the first 5 postoperative<br /><br>days.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Intraoperative fluid strategy<br /><br>• Intraoperative complications including:<br /><br>- Desaturations<br /><br>- Hypotensions<br /><br>- Need for vasoactive medications<br /><br>- New arrhythmias needing intervention<br /><br>• Impaired wound healing<br /><br>• Postoperative extrapulmonary complications<br /><br>• All-cause mortality at day 5, day 90 and day 90<br /><br>• Unplanned admission to an intensive care and length of stay in Intensive care<br /><br>unit<br /><br>• Length of hospital stay.</p><br>