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Reliability of a New Pulse Contour Technique for Diagnosing an Increase in Stroke Volume During a Fluid Challenge for Hemodynamic Optimization in Patients Scheduled for High-risk Abdominal Surgery: Comparison With Transthoracic Echocardiography: COMPARE Study (COMPARE)

2026年6月16日 更新者:Centre Hospitalier Universitaire de Nīmes
The present study aims at assessing the ability of a new pulse contour device for diagnosing a >15% stroke volume (SV) increase during patient hemodynamic optimization by fluid challenge in high risk abdominal surgery.

研究概览

详细说明

In European countries, day-7 mortality rate could reach 1-5. %. Emergency conditions, American Society Assessment (ASA) and major surgery were associated with a higher risk of immediate mortality. Moreover, hemodynamic instability is well known to lead to postoperative complications and a higher risk of mortality.

Since, nearly 30 years, optimization of hemodynamic conditions, especially via an optimization of the fluid administration has been shown to improve immediate and long-term patient outcome. This strategy is currently widely accepted and recommended in medium and high-risk surgery. Therefore, optimizing cardiac output and one of its surrogate is proposed over intraoperative surgery. For assessing the cardiac output or the indexed stroke volume, esophageal Doppler and pulse contour technique have been proposed and have shown that they could improve patient outcome.

However, the reliability of esophageal Doppler, pulse contour and non-invasive techniques assessing cardiac output and its ability to detect a change in the initial value of CO have been challenged. Initially, the reliability of a technique for measuring CO has been described by using a correlation coefficient and by building Bland & Altman diagram. However, searching a correlation between two different techniques measuring the same parameter will lead to a correlation. In the same, Bland & Altman technique shows the mean difference between measurements of the same parameters; However, demonstrating a good reliability should be shown by a narrow limit of agreement with no definition of the narrowness. Indeed, a value of cardiac index (CI) = 3 l/min/m2 with a mean difference of 0 +/- 1.1 /min/m2 by Bland & Altman technique mean that the CI value could be within 1 and 5 l/min/m2 that could lead to different treatment such as fluid challenge, vasopressor or inotrope infusion.

An interesting method for comparing two techniques measuring the same parameter could be to challenge one technique versus the other one in decision-making. Applying this method to techniques measuring CO, we could search for the interest of a new technique for diagnosing an increase in CO after a fluid challenge for optimizing cardiac preload and hemodynamic status. Esophageal Doppler is classically recommended for optimizing hemodynamic patient in high-risk surgery.

A new device using pulse contour technology has been available since a few years. Therefore, the present study aims at assessing the ability of this device for diagnosing an increase in CO > 15% during patient hemodynamic optimization by fluid challenge.

研究类型

观察性的

注册 (实际的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Nîmes、法国、30029
        • CHU de Nîmes

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

取样方法

概率样本

研究人群

Patients scheduled for intermediate and high-risk abdominal surgery were eligible to participate

描述

Inclusion Criteria:

  • Adult patient ASA status 1-3 who were orally informed and did refuse to participate.
  • Patient in whom general anesthesia with tracheal intubation were planned.
  • Patient in whom an arterial catheter and a monitoring of cardiac output by esophageal Doppler were indicated for hemodynamic optimization
  • Patient with cardiac sinusal mode

Exclusion Criteria:

  • Patient < 18-year-old
  • Cardiac arrythmia
  • Patient with anomaly in oro-pharyngo-esophageal tractus
  • Patients with hemostasis anomaly (PT < 30%, platelets < 50 000 elements/mm3)
  • Patient in whom the cardiac output monitoring or measurement was not possible by Esophageal Doppler or echography
  • Patients in whom cardiac arrythmia occurred during the procedure of hemodynamic optimization.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
Hemodynamic optimization
Patients scheduled for intermediate and high-risk abdominal surgery were eligible to participate
The stroke volume will be measured before and after 15 minutes fluid challenge with crystalloids

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Ability of pulse contour for diagnosing a >15% increase in stroke volume
大体时间:15 minutes
Ability of pulse contour for diagnosing a >15% increase in stroke volume
15 minutes

次要结果测量

结果测量
措施说明
大体时间
Comparison with the ability of other techniques
大体时间:15 minutes
Comparison with the ability of other techniques (Esophagial Doppler, other pulse contour techniques for diagnosing a >15% SV increase)
15 minutes
Ability for predicting a >15% SV increase
大体时间:15 minutes
Ability of Esophagial Doppler and Pulse contour techniques for predicting a >15% SV increase after rapid infusion of 100ml cristalloid over one minute (mini-fluid challenge)
15 minutes

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年4月12日

初级完成 (实际的)

2024年1月8日

研究完成 (实际的)

2024年1月8日

研究注册日期

首次提交

2021年4月29日

首先提交符合 QC 标准的

2021年4月29日

首次发布 (实际的)

2021年5月4日

研究记录更新

最后更新发布 (实际的)

2026年6月18日

上次提交的符合 QC 标准的更新

2026年6月16日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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