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临床试验/NCT04142684
NCT04142684已完成不适用

Phrenic Nerve Conduction Study to Diagnose Unilateral Diaphragmatic Paralysis

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2020年1月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
Diaphragm evaluation-compound muscle action potential

研究概览

简要总结

The study aims as the principal objective to compare two approaches to diagnosis unilateral diaphragmatic paralysis: transdiaphragmatic pressure (Pdi) measurement versus phrenic nerve conduction (NPC) study.

The secondary objective of the study is the strengths and weaknesses of different tests. Diagnostic threshold values.

详细描述

Inpatient patients in Raymond Poincaré hospital are informed of the utilization of their data retrospectively by the hospital's welcome booklet and reports of patients' hospitalization.

Period of date collected: November 2015 to June 2018.

The reference standard was the diagnosis established during a multidisciplinary meeting held during patient management involving a neurologist, an electrophysiologist, a pulmonologist, and a respiratory physiologist. The medical history, physical findings, and all available investigations including imaging studies, ENMG, lung function tests, and Pdi measurement were considered during the meeting.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Patient ≥ 18 years;
  • Available data of Pdi and PNC;
  • Suspected unilateral diaphragmatic paralysis.

排除标准

  • Abnormalities in thoracic wall which susceptible to modify the investigation's results;
  • Scoliosis;
  • Pleural effusion.

结局指标

主要结局

Diaphragm evaluation-compound muscle action potential

时间窗: at 1 month

Right and left diaphragm compound muscle action potential (CMAP) : CMAP of Right and left diaphragm were elicited by transcutaneous electrical stimulation of phrenic nerves at the posterior edge of the sternocleido mastoid muscle. They are recorded with two surface electrodes positioned in the eighth intercostal space. The intensity of electrical stimulation was increased until no additional increment in diaphragm CMAP was observed. CMAP amplitude of 300µV or greater and latencies of 9 milliseconds or less were considered normal.

Diaphragm evaluation-transdiaphragmatic pressure

时间窗: at 1 month

Transdiaphragmatic pressure (Pdi) was computed as the difference between gastric and esophageal pressure. Pdi was considered normal when magnetic stimulation of both phrenic nerves induced a Pdi change (Pdi Twitch) above 18 cmH2O and unilateral stimulation of each nerve induced a Pdi change (unilat-Pdi Twitch) above 4 cmH2O and ratio of the two unilat-Pdi Twitch \> 0.5. and \< 2.

次要结局

  • Lung volume measurements(1 month)
  • Spirometry(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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