Anaesthetic Management Guided by COMET Measurements (AIMED COMET)

April 23, 2023 updated by: Rick Hulskes

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
        • Amsterdam UMC, University of Amsterdam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: COMET monitoring device
Anaesthetists for patients allocated to the intervention group were asked to strive and maintain the intraoperative mitoPO2 to the individualised preoperative baseline mitoPO2 with a minimum of 66 mmHg
Other: COMET monitoring device
Cellular Oxygen METabolism (COMET) mitochondrial oxygen tension monitoring device
No Intervention: Control group
Patients allocated to the control group were treated as per anaesthetist preference and followed our institution's conventional care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean mitoPO2 during abdominal surgery over time
Time Frame: during surgery
Absolute difference between the means of the mean mitoPO2
during surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Surgical site infection
Time Frame: 30 days follow-up
Surgical site infection rate according to the CDC definition [1].
30 days follow-up
MitoPO2 above baseline
Time Frame: during surgery
The percentage of surgery time that the intraoperative mitoPO2 is above baseline
during surgery
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)).
during intraoperative anaesthetic procedure
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.
during intraoperative anaesthetic procedure
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.
during surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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].
during surgery
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].
during surgery
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].
during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rick Hulskes

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Photonics Healthcare B.V., Utrecht, The Netherlands

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Markus W Hollmann, Professor, Amsterdam UMC, University of Amsterdam, Department of Anaesthesiology
  • Study Director: Stijn W de Jonge, MD, Amsterdam UMC, University of Amsterdam, Department of Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 26, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL77186.018.21
  • NL9505 (Registry Identifier: Netherlands Trial Register)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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