Clinical trial NCT06822361: Uncalibrated Pulse Contour to Assess Fluid Responsiveness in Off Pump Cardiac Surgery
Official title: Assessment of Response to Vascular Filling by Uncalibrated Pulse Wave Contour Analysis in Beating Heart Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Surgery
Keywords: vascular filling
systolic ejection volume
uncalibrated pulse-wave contour analysis
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient admitted to the cardiac surgery department for surgery under extracorporeal circulation

Brief summary: The goal of this observational study is to Compare the performance of uncalibrated pulse wave contour analysis compared with transesophageal echocardiography (TEE) to assess response to a vascular filling test during beating-heart coronary artery bypass surgery, in people over age of 18; hospitalized for scheduled beating heart bypass surgery The aim question is to evaluate the ability of a less invasive cardiac output monitor (uncalibrated pulse wave contour analysis) compared with a reference cardiac output measurement (transesophageal echocardiography) to enable optimization of vascular filling by good assessment of the response to vascular filling in a high-risk perioperative patient population.

As part of hemodynamic monitoring, every patient undergoing beating-heart coronary bypass surgery is fitted with a radial arterial catheter immediately after induction of anesthesia, enabling continuous measurement of blood pressure. Hemodynamic optimization in these patients also involves fitting a transesophageal ultrasound probe to optimize cardiac output using the various therapies available (vascular filling, vasopressors, inotropes).

A specific sensor (FloTrac°, Hemosphere, Edwards°) will be connected to the arterial pressure line to obtain a systolic ejection volume value by analyzing the contour of the uncalibrated pulse wave.

The hemodynamic management of the patient, and the decision to perform a vascular filling test, will be left to the discretion of the practitioner in charge of the patient in the operating room.


Eligibility criteria: Inclusion Criteria:

Patient :

* 18 years of age and older
* Hospitalized for scheduled beating-heart coronary bypass surgery
* Beneficiary of a social security plan
* Not opposed to participating

Exclusion Criteria:

* Patients undergoing surgery with extracorporeal circulation
* Patients with a history of surgery or intra-esophageal pathology contraindicating TEE
* Patient refusing to participate in the study
* Unavailability of TEE or uncalibrated pulse-wave contour device
* Minors
* Protected adults, adults unable to give consent and not under protective supervision
* Persons deprived of liberty, hospitalized without consent
* Pregnant women, parturients and nursing mothers
* Patients not affiliated to the social security system
* Emergency situations

Primary outcomes:
measure: Response to vascular filling
timeFrame: From enrollment to completion of chirurgy (24 hours)
Secondary outcomes:
Other outcomes:
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Study officials:
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