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临床试验/NCT02881814
NCT02881814进行中(未招募)不适用

Evaluation of the Impact of Lung and Diaphragm Ultrasound Findings on Clinical Decisions for Chest Physiotherapy in Patients Hospitalized in Intensive Care Units

Fondation Hôpital Saint-Joseph8 个研究点 分布在 2 个国家目标入组 153 人开始时间: 2017年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
153
试验地点
8
主要终点
Net Reclassification Index (NRI)

研究概览

简要总结

Introduction: Physiotherapist usually uses a clinical examination, including auscultation, an analysis of blood gasses and chest imaging to determine the indication for chest physiotherapy, to choose the treatment protocol and evaluate the efficacy of the management. Lung ultrasound (LUS) presents greater accuracy than chest X-ray in the diagnosis of lung deficiencies interesting the physiotherapist. So, it could allow the physiotherapist to determine the indication for chest physiotherapy and thus avoid unnecessary or inappropriate treatments. No study has evaluated the impact of LUS on clinical decisions in chest physiotherapy in ICU patients.

Objective: To evaluate the impact of using the results of lung and diaphragm US on clinical decisions in chest physiotherapy in hypoxemic patients hospitalized in ICU.

Method: The physiotherapist carries out a clinical examination and analyses the complementary tests (chest X-ray, chest CT-scan and blood gasses if available). Following the examination, he will put forward one or several hypotheses concerning the respiratory deficiency and will confirm or not the indication for chest physiotherapy. If respiratory physiotherapy is indicated, the physiotherapist will specify the protocol.

A lung and diaphragm US will be done following the evaluation of the clinical physiotherapist, and will make it possible to answer the question: are the results of the lung and diaphragm US compatible with the hypotheses put forward? The LUS report will be given to the clinical physiotherapist. He will specify the respiratory physiotherapy protocol according to the results of the US-scan.

The modification of the clinical decision will be assessed with the Net Reclassification Index (NRI).

Expected results: We expect that decisions for chest physiotherapy will be modified by LUS. The expected benefit for patients is therefore that they will be given a chest physiotherapy protocol that is better suited to the type of respiratory deficiency they are suffering from.

详细描述

Research hypothesis The lung and diaphragm ultrasound findings provided to the physiotherapist will modify his/her clinical decision-making in regards to chest physiotherapy treatment in the critical care patient.

Objectives Principal objective The principal objective of this study is to evaluate the impact of using the results of lung and diaphragm US on clinical decisions by physiotherapists regarding chest physiotherapy in patients hospitalized in an ICU.

Secondary objectives

  1. Determine the accuracy of physiotherapist diagnosis of lung pathology using routine clinical assessment versus LUS findings;
  2. Determine the frequency of change in chest physiotherapy treatment with the addition of LUS results to clinical assessment;
  3. Determine the frequency of change in medical treatment (determined by intensivist) following the addition of LUS results to clinical assessment findings.
  4. Evaluate the diagnostic accuracy of LUS in predicting duration of mechanical ventilation and mortality.

Methodology:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Net Reclassification Index (NRI)

时间窗: Hour 1

Agreement (yes/no) between the lung and diaphragm US diagnosis and the clinical diagnosis and modification (yes/no) of the chest physiotherapy protocol

次要结局

  • Prediction of duration of mechanical ventilation(Final study visit)
  • Prediction of mortality(Final study visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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