Phrenic Nerve Conduction Study to Diagnose Unilateral Diaphragmatic Paralysis

Completed

• Conditions: Unilateral Diaphragmatic Paralysis

• Registration Number: NCT04142684
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-29
• Study Start: 2020-01-24
• Primary Completion: 2020-02-24
• Study Completion: 2020-02-24
• Status Verified: 2021-02
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diaphragm evaluation-transdiaphragmatic pressure	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.
Diaphragm evaluation-compound muscle action potential	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.

Secondary Outcome Measures

Name	Time	Method
Lung volume measurements	1 month	Lung volume measurements will be performed in the upright and supine positions. Upright vital capacity (VC) was reported as % predicted value and the difference between upright and supine VC (VC) as % upright value (normal value \> 75%).
Spirometry	1 month	Spirometry will be performed in the upright and supine positions. Upright vital capacity (VC) was reported as % predicted value and the difference between upright and supine VC (VC) as % upright value (normal value \> 75%).

Trial Locations

Locations (1)

Service de Physiologie et Explorations Fonctionnelles, Hôpital Raymond Poincaré, APHP, France; 🇫🇷 Garches, France