Clinical Trials Directory

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.