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CompletedNCT06822361UPC-OPCSUpdated Mar 18, 2026

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

An observational study in Coronary Surgery, sponsored by Centre Hospitalier Universitaire de la Réunion. Completed at 1 site in Reunion. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Centre Hospitalier Universitaire de la Réunion · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
55
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Surgery

Keywords

  • vascular filling
  • systolic ejection volume
  • uncalibrated pulse-wave contour analysis
03

In context

Lead sponsor

Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
55 participants (actual)
Patient registry
No
06

What researchers measure

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).

    Time frame: From enrollment to completion of chirurgy (24 hours)

07

Study locations

1 site
  • CHU de la Réunion
    Saint-Denis, 97400, Reunion
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2024 to primary completion in Oct 2025, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2024
First posted
Feb 12, 2025
StartActual
Dec 23, 2024
Primary completionActual
Oct 10, 2025
CompletionActual
Oct 10, 2025
Last update
Mar 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06822361
Responsible party
Sponsor
First posted
Feb 12, 2025
Start date
Dec 23, 2024
Primary completion
Oct 10, 2025
Completion
Oct 10, 2025
Last update
Mar 18, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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