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临床试验/NCT06822361
NCT06822361已完成不适用

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

Centre Hospitalier Universitaire de la Réunion1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2024年12月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
55
试验地点
1
主要终点
Response to vascular filling

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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
  • •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

结局指标

主要结局

Response to vascular filling

时间窗: 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).

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

研究点 (1)

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