Non Invasive Ventilation as Airway Clearance in Patients With Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT02083263|
Recruitment Status : Completed
First Posted : March 11, 2014
Results First Posted : July 3, 2014
Last Update Posted : July 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Device: Bilevel Device: PEP mask||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Non Invasive Ventilation With High Pressure as Airways Clearance Technique in Adults Patients With Cystic Fibrosis|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Bilevel, 3 months. The treatment was performed twice a day, 1 hour each treatment.
Active Comparator: PEP mask
PEP mask, 3 months. The treatment was performed twice a day, 1 hour each treatment.
Device: PEP mask
- Lung Function: Lung Clearance Index [ Time Frame: up to 3 months ]Lung clearance index was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity) required to reduce end-tidal nitrogen concentration to 1/40th of the starting value.
- Blood Gases:1 Month After Chest Physiotherapy Will Take Blood Gases (Kpa). [ Time Frame: 1 month ]After physiotherapy will take blood gases (kpa) before chest physiotherapy and perform once a month.
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): NCT02083263
|Stockholm, Sweden, 14178|
|Principal Investigator:||Cecilia Rodriguez, Physio||Karolinska Institutet|