Clinical trial NCT05841576: Anaesthetic Management Guided by COMET Measurements
Official title: Anaesthetic Management Guided by Cellular Oxygen Metabolism Measurements in Abdominal Surgery: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitochondrial Oxygenation Measurement
Surgical Site Infection
Keywords: mitochondria
mitochondrial oxygenation
tissue oxygenation
microcirculation
surgical site infection
wound infection
abdominal surgery
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Photonics Healthcare B.V., Utrecht, The Netherlands
First posted: 2023-05-03
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomised, controlled, single-centre, parallel-arm, patient-blinded trial
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean mitoPO2 during abdominal surgery over time
timeFrame: during surgery
Secondary outcomes:
measure: Surgical site infection
timeFrame: 30 days follow-up
measure: MitoPO2 above baseline
timeFrame: during surgery
measure: Exploration analysis of the correlation coefficients between the intraoperative mitoPO2 and the intraoperative monitoring measurement values
timeFrame: during intraoperative anaesthetic procedure
measure: The respective effect per intervention in mitoPO2 after notification in which mitoPO2 aids decision making on anaesthetic management
timeFrame: during intraoperative anaesthetic procedure
measure: Effect when using the COMET in sequentially treated patients in mitoPO2 assessed with a mixed effects model
timeFrame: during surgery
Other outcomes:
measure: MitoPO2 for patients with epidural anaesthesia
timeFrame: during surgery
measure: MitoPO2 for patients per surgical type
timeFrame: during surgery
measure: MitoPO2 below 20 mmHg and 33 mmHg
timeFrame: during surgery
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, University of Amsterdam
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC, University of Amsterdam, Department of Anaesthesiology
name: Markus W Hollmann, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC, University of Amsterdam, Department of Surgery
name: Stijn W de Jonge, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.