About this trial
The goal of this medtech clinical trial is to develop and evaluate a machine learning algoritm to predict low blood pressure episodes during major surgery. The main questions it aims to answer are:
* Could a novel method for cardiac output estimation through alterations in carbon dioxide improve the performance of a blood pressure based algoritm in order to predict low blood pressure episodes during major abdominal surgery? * Will the predictive performance of the algoritm improve with the addition of other patient specific data? * Do the estimated cardiac output and central venous saturation by the novel method agree with our invasive arterial pressure method for cardiac output, and samples via a central venous line, respectively? 300 participants will be anesthetized with total intravenous anesthesia and ventilated with the novel carbon dioxide based method, and arterial and central venous blood gases will be taken regularly throughout the operation. All physiological data will be stored for later analyses and development of the algoritm by machine learning methods. No other invasive interventions will be performed outside our standard clinical peroperative protocol.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Capnodynamic method
DeviceAll patients will be ventilated using the novel capnodynamic method, incorporated in a modified Maquet servo I ventilator. For this reason, all patients will be anesthetized using total intravenous anesthesia.
Treatment groups
Trial outcomes
Primary outcomes
Accuracy of prediction of hypotension 5 minutes ahead of time using capnodynamics and continuous arterial blood pressure measurement.
Specified as the area under receiver operating characteristic curve (AUROC).
Secondary outcomes
Agreement (precision, bias) for the capnodynamic method vs our standard perioperative method for cardiac output
RMSE of the capnodynamic method, based on modified capnography measurements, compared to the pulse contour method for cardiac output. Measured using Bland Altman statistics
Agreement (precision, bias) for the capnodynamic method vs our standard perioperative method for central venous satuation.
RMSE of the capnodynamic method, based on modified capnography measurements, compared to the standard method for central venous saturation (samples from a central venous line) Measured using Bland Altman statistics
Locations
Sponsors and contacts
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