Phrenic Nerve Conduction Study to Diagnose Unilateral Diaphragmatic Paralysis

NCT04142684 | Completed

• 1 other identifier: APHP190618
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Unilateral Diaphragmatic Paralysis

Keywords

Unilateral Diaphragmatic Paralysis; Diagnose; Phrenic Nerve

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Spirometry

  1 month

• Lung volume measurements

  1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

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

Garches, 92380, France

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frédéric LOFASO, MD, PhD

  Service de Physiologie et Explorations Fonctionnelles, Hôpital Raymond Poincaré, APHP, Garches, FRANCE

  PRINCIPAL INVESTIGATOR

• Vivien REYNAUD, MD

  Service de Physiologie et Explorations Fonctionnelles, Hôpital Raymond Poincaré, APHP, Garches, FRANCE

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 29, 2019
• Study Start: January 24, 2020
• Primary Completion: February 24, 2020
• Study Completion: February 24, 2020
• Last Updated: September 28, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)