Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-29 @ 1:35 AM
Study NCT ID:
NCT06822361
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-12
First Post:
2024-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uncalibrated Pulse Contour to Assess Fluid Responsiveness in Off Pump Cardiac Surgery
Sponsor:
Centre Hospitalier Universitaire de la Réunion
Organization:
Study Overview
Official Title:
Assessment of Response to Vascular Filling by Uncalibrated Pulse Wave Contour Analysis in Beating Heart Cardiac Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UPC-OPCS
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-A02390-47 | OTHER | ID-RCB | View |