- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01569217
Regional Distribution of Ventilation to Assess Respiratory Muscle Dysfunction (DREM)
Construction of a Database to Identify Early Indicators of Respiratory Muscle Dysfunction in Neuromuscular Patients From the Optoelectronic Plethysmography Assessment of the Thoracoabdominal Motion
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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Garches, France, 92380
- Raymond Poincaré Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- suspicion of respiratory muscle dysfunction
- indication of diaphragm exploration
Exclusion Criteria:
- acute respiratory failure
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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respiratory muscle dysfunction patients
Neuromuscular patients
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diaphragmatic dysfunction
patients who present orthopnea, recruitment of accessory muscles, abdominal paradox, respiratory dysfunction or dyssynchronous movement
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
compartmental distribution of the inspired/expired volumes
Time Frame: 1 hour
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
left side and right side contribution to the inspired/expired volumes
Time Frame: 1 hour
|
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.
|
1 hour
|
Collaborators and Investigators
Investigators
- Principal Investigator: Frederic Lofaso, MD, PhD, Centre d'Investigation Clinique et Technologique 805
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11 003-CCP Ile de France XI
- 11.155 bis (Registry Identifier: CCTIRS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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