Phrenic Nerve Conduction Study to Diagnose Unilateral Diaphragmatic Paralysis (ENMG-DIAPH)

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.

Study Overview

• Status: Completed
• Conditions: Unilateral Diaphragmatic Paralysis

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 Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• France
  • Garches, France, 92380
    • Service de Physiologie et Explorations Fonctionnelles, Hôpital Raymond Poincaré, APHP, France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients suspected unilateral diaphragmatic paralysis with available Pdi and PNC data.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Frédéric LOFASO, MD, PhD, Service de Physiologie et Explorations Fonctionnelles, Hôpital Raymond Poincaré, APHP, Garches, FRANCE; Study Director: Vivien REYNAUD, MD, Service de Physiologie et Explorations Fonctionnelles, Hôpital Raymond Poincaré, APHP, Garches, FRANCE

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 24, 2020
• Primary Completion (ACTUAL): February 24, 2020
• Study Completion (ACTUAL): February 24, 2020

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (ACTUAL): October 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Diagnose; Phrenic Nerve; Unilateral Diaphragmatic Paralysis
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Respiratory Insufficiency; Paralysis; Respiratory Paralysis
• Other Study ID Numbers: APHP190618

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No