Regional Distribution of Ventilation to Assess Respiratory Muscle Dysfunction

This study is currently recruiting participants.

Verified April 2013 by Centre d'Investigation Clinique et Technologique 805

Sponsor:

Information provided by (Responsible Party):

Lofaso, Centre d'Investigation Clinique et Technologique 805

ClinicalTrials.gov Identifier:

NCT01569217

First received: March 27, 2012

Last updated: April 11, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 27, 2012

Last Updated Date

April 11, 2013

Start Date ^ICMJE

June 2011

Estimated Primary Completion Date

January 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

compartmental distribution of the inspired/expired volumes [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01569217 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

left side and right side contribution to the inspired/expired volumes [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

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 each side contribution of these volumes will be expressed in percentage.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Regional Distribution of Ventilation to Assess Respiratory Muscle Dysfunction

Official Title ^ICMJE

Construction of a Database to Identify Early Indicators of Respiratory Muscle Dysfunction in Neuromuscular Patients From the Optoelectronic Plethysmography Assessment of the Thoracoabdominal Motion

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".

Detailed Description

All patients which had suspected respiratory muscle dysfunction will have usual exploration of the respiratory muscles according to the clinician prescription. These explorations can include :

Lung volumes in seating and supine position
Maximal inspiratory and expiratory pressures
Maximal sniff pressures

And when diaphragmatic dysfunction is suspected :

Maximal transdiaphragmatic pressure
Phrenic nerve conduction

These patients will also beneficiate to the determination of volume variations of the upper rib cage, the lower rib cage and the abdominal compartments by using Opto-electronic plethysmography.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Neuromuscular patients

Condition ^ICMJE

Respiratory Failure
Neuromuscular Disorder
Diaphragmatic Paralysis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

500

Estimated Completion Date

January 2016

Estimated Primary Completion Date

January 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

suspicion of respiratory muscle dysfunction
indication of diaphragm exploration

Exclusion Criteria:

acute respiratory failure

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Frédéric LOFASO, MD-PhD

0147107941

f.lofaso@rpc.aphp.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01569217

Other Study ID Numbers ^ICMJE

11 003-CCP Ile de France XI, 11.155 bis

Has Data Monitoring Committee

Yes

Responsible Party

Lofaso, Centre d'Investigation Clinique et Technologique 805

Study Sponsor ^ICMJE

Centre d'Investigation Clinique et Technologique 805

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Frédéric Lofaso, MD, PhD

Centre d'Investigation Clinique et Technologique 805

Information Provided By

Centre d'Investigation Clinique et Technologique 805

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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