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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
98
Cellular Oxygen METabolism (COMET) mitochondrial oxygen tension monitoring device
Amsterdam UMC, University of Amsterdam
Amsterdam, North Holland, Netherlands
Mean mitoPO2 during abdominal surgery over time
Absolute difference between the means of the mean mitoPO2
Time frame: during surgery
Surgical site infection
Surgical site infection rate according to the CDC definition \[1\].
Time frame: 30 days follow-up
MitoPO2 above baseline
The percentage of surgery time that the intraoperative mitoPO2 is above baseline
Time frame: 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)).
Time frame: 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.
Time frame: 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.
Time frame: during surgery
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