Phrenic Nerve Conduction Study to Diagnose Unilateral Diaphragmatic Paralysis

Unilateral Diaphragmatic Paralysis Clinical Trial

— ENMG-DIAPH  

Official title:

Phrenic Nerve Conduction Study to Diagnose Unilateral Diaphragmatic Paralysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04142684
• Other study ID #: APHP190618
• Status: Completed
• Start date: January 24, 2020
• Est. completion date: February 24, 2020

Study information

• Verified date: February 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 24, 2020
• Est. primary completion date: February 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Paralysis
• Respiratory Paralysis
• Unilateral Diaphragmatic Paralysis

Locations

Country	Name	City	State
France	Service de Physiologie et Explorations Fonctionnelles, Hôpital Raymond Poincaré, APHP, France	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragm evaluation-compound muscle action potential	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.	at 1 month
Primary	Diaphragm evaluation-transdiaphragmatic pressure	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.	at 1 month
Secondary	Spirometry	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%).	1 month
Secondary	Lung volume measurements	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%).	1 month