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

NCT06822361 | Completed

• 2 other identifiers: 2024/CHU/572024-A02390-47
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Surgery

Keywords

vascular filling; systolic ejection volume; uncalibrated pulse-wave contour analysis

Outcome Measures

Primary Outcomes (1)

• Response to vascular filling

  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)

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

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

CHU de la Réunion

Saint-Denis, 97400, Reunion

Location

Study Design

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

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: February 12, 2025
• Study Start: December 23, 2024
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

RE (1)