NCT05841576

Anaesthetic Management Guided by COMET Measurements

Anaesthetic Management Guided by Cellular Oxygen Metabolism Measurements in Abdominal Surgery: a Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Rick Hulskes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Surgical site infection (SSI) is a significant cause of morbidity and mortality, prolonged hospital stays and healthcare costs. Perioperative low tissue oxygen tension is associated with a high risk of SSI. Standard anaesthetic management guided by continuous monitoring of oxygen delivery with a non-invasive method of measuring mitochondrial oxygenation tension (mitoPO2) using the Cellular Oxygen METabolism (COMET) monitor may benefit the intraoperative oxygenation on the tissue level. This randomised, controlled, single-centre, parallel-arm, patient-blinded trial aims to investigate if standard anaesthetic management guided by mitoPO2 monitoring results in higher tissue oxygen tension including patients undergoing elective abdominal surgery. Anaesthetists in the intervention group strive to a minimum mitoPO2 of 66 mmHg. Patients in the control group receive standard care. The primary outcome is the difference in means of the mean mitoPO2 during surgery.

Conditions

• Mitochondrial Oxygenation Measurement
• Surgical Site Infection

Interventions

Type	Name	Description
OTHER	COMET monitoring device	Cellular Oxygen METabolism (COMET) mitochondrial oxygen tension monitoring device

Timeline

• Start date: 2021-09-22
• Primary completion: 2022-11-26
• Completion: 2022-11-26
• First posted: 2023-05-03
• Last updated: 2023-05-03

Locations

1 site across 1 country: Netherlands