Anaesthetic Management Guided by COMET Measurements

Surgical Site Infection Clinical Trial

— AIMED COMET  

Official title:

Anaesthetic Management Guided by Cellular Oxygen Metabolism Measurements in Abdominal Surgery: a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05841576
• Other study ID #: NL77186.018.21
• Secondary ID: NL9505
• Status: Completed
• Phase: N/A
• Start date: September 22, 2021
• Est. completion date: November 26, 2022

Study information

• Verified date: April 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: November 26, 2022
• Est. primary completion date: November 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Mitochondrial Oxygenation Measurement
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Other:
• COMET monitoring device
Cellular Oxygen METabolism (COMET) mitochondrial oxygen tension monitoring device

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, University of Amsterdam	Amsterdam	Noord-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Rick Hulskes	Photonics Healthcare B.V., Utrecht, The Netherlands

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MitoPO2 for patients with epidural anaesthesia	Similair as the primary outcome, but exploring the effect in patients with or without epidural anaesthesia [2].	during surgery
Other	MitoPO2 for patients per surgical type	Similair as the primary outcome, but exploring the effect in patients with open versus laparoscopic surgical procedure [3].	during surgery
Other	MitoPO2 below 20 mmHg and 33 mmHg	The percentage of surgery time that the mitoPO2 is below 20mmHg and below 33 mmHg [4,5].	during surgery
Primary	Mean mitoPO2 during abdominal surgery over time	Absolute difference between the means of the mean mitoPO2	during surgery
Secondary	Surgical site infection	Surgical site infection rate according to the CDC definition [1].	30 days follow-up
Secondary	MitoPO2 above baseline	The percentage of surgery time that the intraoperative mitoPO2 is above baseline	during surgery
Secondary	Exploration analysis of the correlation coefficients between the intraoperative mitoPO2 and the intraoperative monitoring measurement values	Calculation of the correlation coefficients between the intraoperative mitoPO2 values and the intraoperative values of each monitoring measurement. The measurement pairs are defined as measurements performed within the same time interval. The mean value is used if multiple measurements of the same type have been performed in that time interval. The outcomes are the pooled correlation coefficients of the correlation between the mitoPO2 and each monitoring measure. We going to examine the following monitoring measurements: non-invasive or arterial blood pressure in mmHg, plethysmographic variability index, heart rate, peripheral oxygen saturation, temperature in Celsius, end-tidal oxygen in mmHg, end-tidal carbon dioxide in mmHg and amplitude frequency effect (pulse pressure and heart rate)).	during intraoperative anaesthetic procedure
Secondary	The respective effect per intervention in mitoPO2 after notification in which mitoPO2 aids decision making on anaesthetic management	The potential effects of the anaesthetic interventions on the mitoPO2 values is assessed amongst patients from the intervention group. The anaesthetic interventions of interest are only those given to increase the mitoPO2 values. For all these interventions, we look for the difference between aggregated mitoPO2 values over a period before administering the anaesthetic intervention and aggregated mitoPO2 values over a period when the treatment is active. The lengths of the intervals, the time between intervals, and the type of aggregation are based on the observable patterns in the data. The time between intervals is at least the average time for the anaesthetic intervention to reach maximum plasma concentration; this duration may be longer because the effect could be delayed. If possible, we summarise the effect of the anaesthetic interventions by type and dose.	during intraoperative anaesthetic procedure
Secondary	Effect when using the COMET in sequentially treated patients in mitoPO2 assessed with a mixed effects model	The relationship between the intervention number of patients from the interventions group sequentially treated by one anaesthetist and the mean intraoperative mitoPO2 value. The effect is defined as the average increase in mean intraoperative mitoPO2 when an anaesthetist treats a new patient from the intervention group.	during surgery

External 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