Skip to main content
OpenTrials
Completed

NCT Number: NCT05841576

Anaesthetic Management Guided by COMET Measurements

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mitochondrial Oxygenation Measurement Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Site Infection Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC, University of Amsterdam

Amsterdam, North Holland, 1105 AZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients are at least 18 years old
  • Patients undergo elective open or laparoscopic abdominal surgery with an expected minimal total incision size of 5 cm
  • Patients are able and willing to give written informed consent

Exclusion criteria

  • Known photodermatoses of varying pathology and frequency
  • Mitochondrial disease
  • Porphyria
  • Skin lesions on the upper arm which impede measurements
  • Hypersensitivity to the active substance or the 5-ALA medicated plaster material
  • Emergency surgery
  • Reoperation for complications from recent surgery (within last three months)
  • Participation in another study with interference with this study
  • Pregnancy or breastfeeding

Treatment and study plan

COMET monitoring device

Other

Cellular Oxygen METabolism (COMET) mitochondrial oxygen tension monitoring device

Primary outcomes

  1. Mean mitoPO2 during abdominal surgery over time

    Time frame: during surgery

    Absolute difference between the means of the mean mitoPO2

Secondary outcomes

  1. Surgical site infection

    Time frame: 30 days follow-up

    Surgical site infection rate according to the CDC definition [1].

  2. MitoPO2 above baseline

    Time frame: during surgery

    The percentage of surgery time that the intraoperative mitoPO2 is above baseline

  3. Exploration analysis of the correlation coefficients between the intraoperative mitoPO2 and the intraoperative monitoring measurement values

    Time frame: during intraoperative anaesthetic procedure

    Calculation of the correlation coefficients between the intraoperative mitoPO2 values and the intraoperative values of each monitoring measurement. The measurement pairs are defined as measurements performed within the same time interval. The mean value is used if multiple measurements of the same type have been performed in that time interval. The outcomes are the pooled correlation coefficients of the correlation between the mitoPO2 and each monitoring measure. We going to examine the following monitoring measurements: non-invasive or arterial blood pressure in mmHg, plethysmographic variability index, heart rate, peripheral oxygen saturation, temperature in Celsius, end-tidal oxygen in mmHg, end-tidal carbon dioxide in mmHg and amplitude frequency effect (pulse pressure and heart rate)).

  4. The respective effect per intervention in mitoPO2 after notification in which mitoPO2 aids decision making on anaesthetic management

    Time frame: during intraoperative anaesthetic procedure

    The potential effects of the anaesthetic interventions on the mitoPO2 values is assessed amongst patients from the intervention group. The anaesthetic interventions of interest are only those given to increase the mitoPO2 values. For all these interventions, we look for the difference between aggregated mitoPO2 values over a period before administering the anaesthetic intervention and aggregated mitoPO2 values over a period when the treatment is active. The lengths of the intervals, the time between intervals, and the type of aggregation are based on the observable patterns in the data. The time between intervals is at least the average time for the anaesthetic intervention to reach maximum plasma concentration; this duration may be longer because the effect could be delayed. If possible, we summarise the effect of the anaesthetic interventions by type and dose.

  5. Effect when using the COMET in sequentially treated patients in mitoPO2 assessed with a mixed effects model

    Time frame: during surgery

    The relationship between the intervention number of patients from the interventions group sequentially treated by one anaesthetist and the mean intraoperative mitoPO2 value. The effect is defined as the average increase in mean intraoperative mitoPO2 when an anaesthetist treats a new patient from the intervention group.

Other outcomes

  1. MitoPO2 for patients with epidural anaesthesia

    Time frame: during surgery

    Similair as the primary outcome, but exploring the effect in patients with or without epidural anaesthesia [2].

  2. MitoPO2 for patients per surgical type

    Time frame: during surgery

    Similair as the primary outcome, but exploring the effect in patients with open versus laparoscopic surgical procedure [3].

  3. MitoPO2 below 20 mmHg and 33 mmHg

    Time frame: during surgery

    The percentage of surgery time that the mitoPO2 is below 20mmHg and below 33 mmHg [4,5].

Sponsors and collaborators

Lead sponsor

Rick Hulskes

Other

Collaborators

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

Registry information

Official study title

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

Acronym: AIMED COMET

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 3, 2023
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.