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临床试验/NCT05957003
NCT05957003已完成不适用

The Validity of Combined End-expiratory and End-inspiratory Occlusion Test and Tidal Volume Challenge Test for Prediction of Fluid Responsiveness in Immediate Post-cardiac Surgery Patients

Tanta University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年8月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
The number of volume responder participants could be detected using each fluid responsiveness test

研究概览

简要总结

the study aims to examine the validity of combined end-expiratory and end-inspiratory occlusion test and tidal volume challenge test for prediction of fluid responsiveness in immediate post-cardiac surgery patients

详细描述

multiple studies prove that dynamic variables based on heart-lung interactions accurately can predict fluid responsiveness in mechanically ventilated patients, including pulse pressure variation (PPV) and stroke volume (SV) variation.

Furthermore, passive leg raising (PLR), end-expiratory occlusion test, and tidal volume challenge test, "Mini"-fluid challenge are currently available to assess fluid responsiveness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

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

  • •Patients on mechanical ventilation
  • •Patients ≥18 years of age
  • •patients undergoing cardiac surgery (coronary artery bypass graft, valve repair/ replacement, combined cardiac surgery)
  • •patients with normal systolic function of the left and right ventricle
  • •patient is mechanically ventilated with a protective lung strategy

排除标准

  • •Patients with Spontaneously breathing activity
  • •Patients undergoing emergent cardiac surgery.
  • •Patient with severe peripheral arterial occlusive disease
  • •Pregnant women
  • •Contraindication of passive leg raising test
  • •unstable post-operative course
  • •Post-operative complications such as uncontrolled bleeding, severe neurologic impairment, or accidental mechanical complications;
  • •presence of residual severe tricuspid or any valvular regurgitations
  • •low cardiac output, low ejection fractions (EF ≤45%)
  • •open chest,Pao2/Fio2 ≤ 200

研究组 & 干预措施

occlusions test

Active Comparator

Combined end expiratory (EEO) and inspiratory occlusion (EIO) test. A 15-s EEO separated by a time window of 1 minute to allow the hemodynamic parameters to return to baseline followed by a 15-s EIO

干预措施: Combined end-expiratory occlusion and end-inspiratory occlusion test (Procedure)

challenge test

Active Comparator

Tidal volume (TV) challenge test (transient increase of TV from 6 to 8 mL/kg for 1 minute)

干预措施: Tidal volume challenge test (Procedure)

结局指标

主要结局

The number of volume responder participants could be detected using each fluid responsiveness test

时间窗: immediate postoperative period

The number of volume responder participants could be detected using each fluid responsiveness test including tidal volume challenge test and combined end-expiratory occlusion and end-inspiratory occlusion test

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

tarek abdel hay mostafa

principle investigator

Tanta University

研究点 (1)

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