- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
-
Garches, Frankrig, 92380
- Raymond Poincaré Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- suspicion of respiratory muscle dysfunction
- indication of diaphragm exploration
Exclusion Criteria:
- acute respiratory failure
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
respiratory muscle dysfunction patients
Neuromuscular patients
|
|
diaphragmatic dysfunction
patients who present orthopnea, recruitment of accessory muscles, abdominal paradox, respiratory dysfunction or dyssynchronous movement
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
compartmental distribution of the inspired/expired volumes
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
left side and right side contribution to the inspired/expired volumes
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Frederic Lofaso, MD, PhD, Centre d'Investigation Clinique et Technologique 805
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 11 003-CCP Ile de France XI
- 11.155 bis (Registry Identifier: CCTIRS)
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