Anaesthetic Management Guided by COMET Measurements

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-22

Study Completion Date

2022-11-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intraoperative Oxygen Concentration on Incidence of Surgical Site Infection

NCT06108791

Surgical Site Infection

RECRUITING NA

Supplemental Perioperative Oxygen to Reduce the Incidence of Post-cesarean Wound Infection

NCT01340534

Surgical Wound Infection

COMPLETED PHASE3

The Association of Intraoperative Oxygen Reserve Index and Postoperative Pulmonary Complications in Robot-assisted Esophagectomy

NCT04008420

Endotracheal Intubation Robotic Esophagectomy Esophagectomy

UNKNOWN

Goal-directed Low Oxygen During Anesthesia

NCT05263154

Postoperative Complications

UNKNOWN NA

Evaluation of Indirect Measurement of Respiratory Quotient in Non-cardiac Major Surgery (The BAR Study)

NCT03471962

Surgery

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mitochondrial Oxygenation Measurement Surgical Site Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

COMET monitoring device

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

Group Type EXPERIMENTAL

COMET monitoring device

Intervention Type OTHER

Cellular Oxygen METabolism (COMET) mitochondrial oxygen tension monitoring device

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

COMET monitoring device

Cellular Oxygen METabolism (COMET) mitochondrial oxygen tension monitoring device

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes