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Artificial Intelligence - to Predict and Prevent Hypotension During Surgery

NCT06240234 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-02-02

No results posted yet for this study

Summary

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.

Conditions

  • Monitoring, Intraoperative

Interventions

DEVICE

Capnodynamic method

All 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.

Sponsors & Collaborators

  • KTH Royal Institute of Technology

    collaborator OTHER

  • Getinge Group

    collaborator OTHER

  • Region Stockholm

    lead OTHER_GOV

Principal Investigators

  • Greg Winski, Dr · Karolinska University Hospital

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2026-12-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06240234 on ClinicalTrials.gov