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| ID | Type | Description | Link |
|---|---|---|---|
| NL9505 | Registry Identifier | Netherlands Trial Register |
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| Name | Class |
|---|---|
| Photonics Healthcare B.V., Utrecht, The Netherlands | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control group | No Intervention | Patients allocated to the control group were treated as per anaesthetist preference and followed our institution's conventional care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COMET monitoring device | Other | Cellular Oxygen METabolism (COMET) mitochondrial oxygen tension monitoring device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean mitoPO2 during abdominal surgery over time | Absolute difference between the means of the mean mitoPO2 | during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection | Surgical site infection rate according to the CDC definition [1]. | 30 days follow-up |
| MitoPO2 above baseline | The percentage of surgery time that the intraoperative mitoPO2 is above baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| MitoPO2 for patients per surgical type |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC, University of Amsterdam | Amsterdam | North Holland | 1105 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14633566 | Result | 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. | |
| 17143850 | 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. |
| Label | URL |
|---|---|
| Reference 1. Network NHS. Surgical Site Infection (SSI) Events | View source |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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A randomised, controlled, single-centre, parallel-arm, patient-blinded trial
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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.
| during surgery |
| 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 |
| 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 |
| 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 |
Similair as the primary outcome, but exploring the effect in patients with open versus laparoscopic surgical procedure [3].
| during surgery |
| 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 |
| 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 | View source |