Skip to main content
OpenTrials
Completed

NCT Number: NCT06822361

Uncalibrated Pulse Contour to Assess Fluid Responsiveness in Off Pump 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de la Réunion

Saint-Denis, 97400, Reunion

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Official study title

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

Acronym: UPC-OPCS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.