Uncalibrated Pulse Contour to Assess Fluid Responsiveness in Off Pump Cardiac Surgery (UPC-OPCS)

March 17, 2026 updated by: Centre Hospitalier Universitaire de la Réunion

Assessment of Response to Vascular Filling by Uncalibrated Pulse Wave Contour Analysis in Beating Heart Cardiac Surgery

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Reunion
      • Saint-Denis, Reunion, 97400
        • CHU de la Réunion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient admitted to the cardiac surgery department for surgery under extracorporeal circulation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to vascular filling
Time Frame: From enrollment to completion of chirurgy (24 hours)
an increase of more than 10% (compared with basal value) in the sub-aortic VTI value measured in TEE after filling (gold standard).
From enrollment to completion of chirurgy (24 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Réunion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2024

Primary Completion (Actual)

October 10, 2025

Study Completion (Actual)

October 10, 2025

Study Registration Dates

First Submitted

December 18, 2024

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

February 12, 2025

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024/CHU/57
  • 2024-A02390-47 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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