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Mitochondrial Oxygenation MeasurementAIMED COMETNCT05841576

Anaesthetic Management Guided by COMET Measurements

A study testing COMET monitoring device in people with Mitochondrial Oxygenation Measurement and Surgical Site Infection, run by Rick Hulskes at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
COMET monitoring device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
1 siteNetherlands
Study dates
22 Sep 2021to 26 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Reoperation for complications from recent surgery (within last three months)
  • Participation in another study with interference with this study
  • Pregnancy or breastfeeding

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Amsterdam UMC, University of Amsterdam

    Amsterdam, North Holland, 1105 AZ

Other trials in Netherlands

About this study

Official title: 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.

Being tested
COMET monitoring device
Keywords
mitochondria, mitochondrial oxygenation, tissue oxygenation, microcirculation, surgical site infection, wound infection, abdominal surgery
Medical subject headings
Surgical Wound Infection, Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COMET monitoring deviceOther

    Cellular Oxygen METabolism (COMET) mitochondrial oxygen tension monitoring device

Study groups in NCT05841576
Study groupRoleWhat they receive
COMET monitoring deviceExperimentalAnaesthetists 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
Receives: Other: COMET monitoring device
Control groupNo interventionPatients allocated to the control group were treated as per anaesthetist preference and followed our institution's conventional care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean mitoPO2 during abdominal surgery over time

    Absolute difference between the means of the mean mitoPO2

    Measured: during surgery

Secondary outcomes (5)

  1. Surgical site infection

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

    Measured: 30 days follow-up

  2. MitoPO2 above baseline

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

    Measured: during surgery

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

    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)).

    Measured: during intraoperative anaesthetic procedure

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

    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.

    Measured: during intraoperative anaesthetic procedure

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

    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.

    Measured: during surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2023
  2. Study start22 Sep 2021
  3. Primary completion26 Nov 2022
  4. Study completion26 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomised, controlled, single-centre, parallel-arm, patient-blinded trial
Masking
Single blind
Who is masked
Participant
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05841576
Sponsor's protocol ID
NL77186.018.21
Other IDs
NL9505
Acronym
AIMED COMET
Status last verified
Apr 2023
First submitted
23 Nov 2022
Last updated
3 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kabon B, Fleischmann E, Treschan T, Taguchi A, Kapral S, Kurz A. Thoracic epidural anesthesia increases tissue oxygenation during major abdominal surgery. Anesth Analg. 2003 Dec;97(6):1812-1817. doi: 10.1213/01.ANE.0000087040.48267.54.

    PubMed 14633566

  • Fleischmann E, Kugener A, Kabon B, Kimberger O, Herbst F, Kurz A. Laparoscopic surgery impairs tissue oxygen tension more than open surgery. Br J Surg. 2007 Mar;94(3):362-8. doi: 10.1002/bjs.5569.

    PubMed 17143850

Questions about this trial

What is this clinical trial studying?

A study testing COMET monitoring device in people with Mitochondrial Oxygenation Measurement and Surgical Site Infection, run by Rick Hulskes at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean mitoPO2 during abdominal surgery over time (time frame: during surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05841576, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.

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