Trials / Completed
CompletedNCT01255111
Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure (ROOMILA)
Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 10 (estimated)
- Sponsor
- Groupe de Recherche sur le Handicap Respiratoire · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
BACKGROUND: Adaptation to noninvasive ventilation (NIV) is a critical step for acceptability and efficacy of this treatment during sleep in patients with chronic respiratory failure. AIM: To study the variability of patient-ventilator interactions during the first nights after initiation to NIV. Recorded data will be analyzed in part by dedicated tools from the non-linear dynamics theory. PATIENTS AND METHODS: Patients with chronic respiratory failure at stable state and indicated to home NIV will be included. All patients will perform three polysomnographies (under spontaneous breathing at D1 and under NIV at D2 and D15 after NIV initiation). All ventilatory physiological data (pressure, flow, patient-ventilator interactions, oxygen saturation, non intentional leaks) will be recorded during sleep under NIV in the Sleep Laboratory of the Department and secondarily related to sleep architecture and quality of sleep. EXPECTED RESULTS: This study will identify objective parameters that are associated to a satisfactory adaptation to nocturnal NIV.
Conditions
Timeline
- Start date
- 2010-10-01
- Completion
- 2011-06-01
- First posted
- 2010-12-07
- Last updated
- 2011-06-23
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT01255111. Inclusion in this directory is not an endorsement.