Regional Distribution of Ventilation to Assess Respiratory Muscle Dysfunction

NCT01569217 | Unknown DMC

• 2 other identifiers: 11 003-CCP Ile de France XI11.155 bis
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to better discriminate respiratory muscle dysfunction by comparing the measurements of thoracoabdominal motion obtained by an optoelectronic recording and the conventional tests of respiratory muscle strength. The final objective is to better select in the future the patients who need more specific assessment of diaphragmatic function like "maximal transdiaphragmatic pressure" measurement and "phrenic nerve stimulation".

Conditions

Respiratory Failure; Neuromuscular Disorder; Diaphragmatic Paralysis

Keywords

Diaphragm; Abdomen; Breathing pattern; dyspnea

Outcome Measures

Primary Outcomes (1)

• compartmental distribution of the inspired/expired volumes

  Measurements of the thoraco-abdominal motion and of the global lung volume changes. Measurements will be done during spontaneous breathing and during vital capacity maneuvers. Therefore the tidal volume, the inspiratory capacity and the expiratory reserve volume will be measured in liters and for each compartiment (upper thorax, lower thorax, abdomen) contribution of these volumes will be expressed in percentage.

  1 hour

Secondary Outcomes (1)

• left side and right side contribution to the inspired/expired volumes

  1 hour

Study Arms (2)

respiratory muscle dysfunction patients

Neuromuscular patients

diaphragmatic dysfunction

patients who present orthopnea, recruitment of accessory muscles, abdominal paradox, respiratory dysfunction or dyssynchronous movement

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

Neuromuscular patients

You may qualify if:

• suspicion of respiratory muscle dysfunction
• indication of diaphragm exploration

You may not qualify if:

• acute respiratory failure

Sponsors & Collaborators

• Centre d'Investigation Clinique et Technologique 805: lead

Study Sites (1)

Raymond Poincaré Hospital

Garches, 92380, France

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Neuromuscular Diseases; Respiratory Paralysis; Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Study Officials

• Frédéric Lofaso, MD, PhD

  Centre d'Investigation Clinique et Technologique 805

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD, Professor

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: April 3, 2012
• Study Start: June 1, 2011
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: May 1, 2017

Record last verified: 2017-04

Locations

FR (1)