Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure (ROOMILA) (ROOMILA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01255111|
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : June 23, 2011
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.
|Condition or disease|
|Chronic Respiratory Failure|
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure|
|Study Start Date :||October 2010|
|Actual Study Completion Date :||June 2011|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255111
|Pulmonary & Respiratory Intensive Care Department - Rouen University Hospital|
|Principal Investigator:||Pr. Antoine CUVELIER, MD, PhD||Groupe de Recherche sur le Handicap Ventilatoire|