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Uncalibrated Pulse Contour to...

Uncalibrated Pulse Contour to Assess Fluid Responsiveness in Off Pump Cardiac Surgery

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-20

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers