Anaesthetic Management Guided by COMET Measurements

NCT05841576 | Completed

• 2 other identifiers: NL77186.018.21NL9505
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitochondrial Oxygenation Measurement; Surgical Site Infection

Keywords

mitochondria; mitochondrial oxygenation; tissue oxygenation; microcirculation; surgical site infection; wound infection; abdominal surgery

Outcome Measures

Primary Outcomes (1)

• Mean mitoPO2 during abdominal surgery over time

  Absolute difference between the means of the mean mitoPO2

  during surgery

Secondary Outcomes (5)

• Surgical site infection

  30 days follow-up

• MitoPO2 above baseline

  during surgery

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

  during intraoperative anaesthetic procedure

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

  during intraoperative anaesthetic procedure

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

  during surgery

Other Outcomes (3)

• MitoPO2 for patients with epidural anaesthesia

  during surgery

• MitoPO2 for patients per surgical type

  during surgery

• MitoPO2 below 20 mmHg and 33 mmHg

  during surgery

Study Arms (2)

COMET monitoring device

EXPERIMENTAL

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

Control group

NO INTERVENTION

Patients allocated to the control group were treated as per anaesthetist preference and followed our institution's conventional care

Interventions

COMET monitoring device OTHER

Cellular Oxygen METabolism (COMET) mitochondrial oxygen tension monitoring device

COMET monitoring device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rick Hulskes: lead
• Photonics Healthcare B.V., Utrecht, The Netherlands: collaborator

Study Sites (1)

Amsterdam UMC, University of Amsterdam

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 14633566 RESULT

• 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.

  PMID: 17143850 RESULT

Related Links

• Reference 1. Network NHS. Surgical Site Infection (SSI) Events
• Reference 4. de Wijs C, et al. MITOCHONDRIAL OXYGENATION DURING CARDIOPULMONARY BYPASS: A PILOT STUDY \[abstract\]. Virtual: In: EACTAIC-ICCVA Joint Congress / Journal of Cardiothoracic and Vascular Anesthesia 35 (2021) S1-S21, 2021
• Reference 5. Hilderink B, et al. Mitochondrial oxygen tension in patients after cardiac surgery: preliminary results \[abstract\]. Madrid, Spain: In: European society of intensive medicine LIVES 40, 2022

MeSH Terms

Conditions

Surgical Wound Infection; Wound Infection

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Markus W Hollmann, Professor

  Amsterdam UMC, University of Amsterdam, Department of Anaesthesiology

  PRINCIPAL INVESTIGATOR

• Stijn W de Jonge, MD

  Amsterdam UMC, University of Amsterdam, Department of Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The mitoPO2 in the control group is covered and made invisible to the anaesthetists. During the procedure, the outcome assessor is present to troubleshoot the device when needed and is also not blinded. Patients, surgeons and healthcare professionals during the postoperative period are blinded to the treatment allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study coordinator

Model Details: A randomised, controlled, single-centre, parallel-arm, patient-blinded trial

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: May 3, 2023
• Study Start: September 22, 2021
• Primary Completion: November 26, 2022
• Study Completion: November 26, 2022
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)