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Anaesthetic Management Guided by COMET Measurements

NCT05841576 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2023-05-03

No results posted yet for this study

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

OTHER

COMET monitoring device

Cellular Oxygen METabolism (COMET) mitochondrial oxygen tension monitoring device

Sponsors & Collaborators

  • Photonics Healthcare B.V., Utrecht, The Netherlands

    collaborator UNKNOWN

  • Rick Hulskes

    lead OTHER

Principal Investigators

  • Markus W Hollmann, Professor · Amsterdam UMC, University of Amsterdam, Department of Anaesthesiology

  • Stijn W de Jonge, MD · Amsterdam UMC, University of Amsterdam, Department of Surgery

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-22
Primary Completion
2022-11-26
Completion
2022-11-26

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05841576 on ClinicalTrials.gov