Non-invasive Measurement of Arterial Stiffness

NCT05654402 | Unknown

• 1 other identifier: APHP2203812
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Predictive medicine; Pulse wave velocity; Cardiovascular complications; Predictive Biomarker; Arterial stiffness

Outcome Measures

Primary Outcomes (6)

• To study the concordance of carotid-femoral pulse wave velocity (PWVcf) values obtained by carotid-femoral Doppler method with those obtained completely noninvasively by continuous PWV estimation under the same conditions during anesthesia.

  Non-invasive measurement of carotid-femoral transit time by Doppler velocimetry (PWV in cm/s).

  1 day

• Study concordance of carotid-femoral pulse wave velocity values obtained by carotid-femoral Doppler method and those obtained completely noninvasively by continuous PWV estimation under the same conditions during anesthesia using mean arterial pressure

  Non-invasive continuous measurement of mean arterial pressure in mmHg.

  1 day

• To study the concordance of carotid-femoral pulse wave velocity values obtained by carotid-femoral Doppler method with those obtained completely noninvasively by continuous PWV estimation under the same conditions during anesthesia using blood pressure.

  Discontinuous measurement of blood pressure with an oscillometric brachial blood pressure monitor.

  1 day

• To study the concordance of carotid-femoral pulse wave velocity (PWVcf) values obtained by carotid-femoral Doppler method with those obtained completely noninvasively by continuous PWV estimation under the same conditions during anesthesia using ECG.

  Continuous ECG recording.

  1 day

• Study concordance of carotid-femoral pulse wave velocity values obtained by carotid-femoral Doppler method and those obtained by continuous PWV estimation under the same conditions during anesthesia thanks to digital photoplethysmography recording

  Continuous digital photoplethysmography recording exprimed in %.

  1 day

• Study concordance of carotid-femoral pulse wave velocity values obtained by carotid-femoral Doppler method and those obtained completely noninvasively by continuous PWV estimation under the same conditions during anesthesia thanks to administred agents

  Quantification of delivered doses of hypnotics, morphinics and paralytic agents.

  1 day

Interventions

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

* 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants or populations are selected based on predefined criteria.

You may qualify if:

• Patients of legal age ( 18 years)
• Eligible for a scheduled surgical procedure under general or locoregional anesthesia.
• Patients who have expressed no objection to participating in this research

You may not qualify if:

• Patients under 18 years of age.
• Carotid or femoral space not available
• Atrial fibrillation arrhythmia (AFA)
• Advanced obliterative arteriopathy of the lower limbs (grade III and IV - Leriche and Fontaine)
• Patient opposed to participation in the protocol
• Pregnant woman
• Patient under judicial protection
• Patient not affiliated to a social health system

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• INSERM UMR-942, Paris, France: collaborator
• M3DISIM: collaborator

Study Sites (1)

AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care

Paris, 75010, France

RECRUITING

MeSH Terms

Interventions

Pulse Wave Analysis

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Joaquim MD MATEO

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Fabrice MD VALLEE, PhD

  Assistance Publique - Hôpitaux de Paris, Department of Anesthesiology and Intensive Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joaquim MD MATEO

CONTACT

+33 (0)149958374; joaquim.mateo@aphp.fr

Fabrice MD VALLEE, PhD

CONTACT

+33 (0)1 49 95 80 71; fabrice.vallee@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 16, 2022
• Study Start: February 10, 2023
• Primary Completion: February 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

FR (1)