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Non-invasive Measurement of Arterial Stiffness

NCT05654402 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 98

Last updated 2023-03-06

No results posted yet for this study

Summary

Reducing the risk of perioperative cardiovascular complications is a major issue for anesthesiology practice and research. Carotid-Femoral Pulse Wave Velocity (PWVcf)is a predictive, early and independent biomarker of cardiovascular events. Despite the unanimous support for PWVcf, it has not been widely used in routine clinical practice because of the complexity of the measurement method. Our team has developed a method to estimate PWVcf continuously in the operating room from the data obtained by the usual monitoring: an electrocardiogram (ECG), a digital photoplethysmography (PPG) and an oscillometric brachial sphygmomanometer for non-invasive blood pressure measurement (NIP). The objective of this study is to validate, during anesthesia, the method of estimation of PWV (obtained using the usual monitoring tools including the parameters derived from the SpO2 signal, NIBP and ECG) by comparing it to the reference method by measuring the carotid-femoral transit time obtained by Doppler effect. The measurement of the carotid-femoral transit time obtained by Doppler effect is totally non-invasive.

Conditions

  • Anesthesia, Local
  • Anesthesia

Interventions

DIAGNOSTIC_TEST

Non-invasive measurement of carotid-femoral transit time by Doppler velocimetry (Athys Medical©) - WAKIe R3 2TC®) (PWV in cm/s)

* Measurement of the carotid-femoral transit time (ms) (recorded on Data Warehouse Connect). * Measurement of the distance between the carotid and femoral points with a tape measure (m). * Calculation of the propagation speed of the wave PWV (expressed in m/s). For all patients PWV in (m/s=) will be collected over three distinct periods: * Before induction (awake without premedication) * During general anesthesia or loco-regional anesthesia * Upon awakening from general anesthesia or lifting of the loco-regional anaesthesia

Sponsors & Collaborators

  • INSERM UMR-942, Paris, France

    collaborator OTHER

  • M3DISIM

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Joaquim MD MATEO · Assistance Publique - Hôpitaux de Paris

  • Fabrice MD VALLEE, PhD · Assistance Publique - Hôpitaux de Paris, Department of Anesthesiology and Intensive Care

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-10
Primary Completion
2024-02-29
Completion
2024-08-31

Countries

  • France

Study Locations

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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 NCT05654402 on ClinicalTrials.gov