NCT05841576 (AIMED COMET) is a NA clinical trial of COMET monitoring device in Mitochondrial Oxygenation Measurement, sponsored by Rick Hulskes.

Who is sponsoring NCT05841576?

NCT05841576 is sponsored by Rick Hulskes.

What drugs are being tested in NCT05841576?

Interventions in NCT05841576: COMET monitoring device.

What condition does NCT05841576 study?

NCT05841576 studies Mitochondrial Oxygenation Measurement, Surgical Site Infection.

Is NCT05841576 still recruiting?

NCT05841576 is currently completed. Last updated 3 May 2023.

Last reviewed 2023-05-03 · How we verify

NCT05841576: AIMED COMET

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Anaesthetic Management Guided by COMET Measurements

Completed NA Last updated 3 May 2023

What this trial tests

NA trial testing COMET monitoring device in Mitochondrial Oxygenation Measurement in 98 participants. Completed in 26 November 2022.

Timeline

22 September 2021

Primary endpoint
26 November 2022

26 November 2022

Quick facts

Lead sponsor	Rick Hulskes
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	98
Start date	22 September 2021
Primary completion	26 November 2022
Estimated completion	26 November 2022
Sites	1 location across Netherlands

Drugs / interventions tested

COMET monitoring device

Conditions studied

Mitochondrial Oxygenation Measurement — all drugs for Mitochondrial Oxygenation Measurement →
Surgical Site Infection — all drugs for Surgical Site Infection →

Sponsor

Rick Hulskes

Who can join

18 and older, any sex, with Mitochondrial Oxygenation Measurement or Surgical Site Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05841576 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rick Hulskes
Last refreshed: 3 May 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05841576.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing