Anaesthetic Management Guided by COMET Measurements (AIMED COMET)

Rick Hulskes

Status: Completed

Conditions: Surgical Site Infection; Mitochondrial Oxygenation Measurement

Treatments: Other: COMET monitoring device

Study type: Interventional

Funder types: Other

Identifiers

NCT05841576

NL9505 (Registry Identifier)

NL77186.018.21

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 2 patient groups

COMET monitoring device

Experimental group

Description:

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

Treatment:

Other: COMET monitoring device

Control group

No Intervention group

Description:

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