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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06822361

Acronym

UPC-OPCS

Enrollment

Registered

2025-02-12

Start date

2024-12-23

Completion date

2025-10-10

Last updated

2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Surgery

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Response to vascular filling	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).

Countries

Reunion

Outcome results