Phrenic Nerve Conduction Study to Diagnose Unilateral Diaphragmatic Paralysis

NCT ID: NCT04142684

Last Updated: 2021-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-24

Study Completion Date

2020-02-24

Brief Summary

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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

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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.

Conditions

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Unilateral Diaphragmatic Paralysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédéric LOFASO, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Vivien REYNAUD, MD

Role: STUDY_DIRECTOR

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

Locations

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

Garches, , France

Site Status

Countries

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France

Other Identifiers

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APHP190618

Identifier Type: -

Identifier Source: org_study_id

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