Non Invasive Ventilation as Airway Clearance in Patients With Cystic Fibrosis

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Device: Bilevel; Device: PEP mask

• Registration Number: NCT02083263
• Lead Sponsor: Karolinska University Hospital

Brief Summary

With the use of Non invasive ventilation the patients with cystic fibrosis will have better lung function (FEV1).

Detailed Description

3 months intervention between PEP an Bilevel. The patients will follow up under 3 months.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-16
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-11
• Results First Submitted: 2014-03-11
• Results First Submitted QC: 2014-06-02
• Status Verified: 2014-07
• Results First Posted: 2014-07-03
• Last Update Submitted: 2014-07-03
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Patients with CF older than 18 years
• FEV1 between 20% and 69% of predictive.
• No acute exacerbation.
• No Burkhordelia Cepacia/MRSA colonization.

Exclusion Criteria

• Children under 18 year
• acute exacerbation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bilevel	Bilevel	Bilevel, 3 months. The treatment was performed twice a day, 1 hour each treatment.
PEP mask	PEP mask	PEP mask, 3 months. The treatment was performed twice a day, 1 hour each treatment.

Primary Outcome Measures

Name	Time	Method
Lung Function: Lung Clearance Index	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.

Secondary Outcome Measures

Name	Time	Method
Blood Gases:1 Month After Chest Physiotherapy Will Take Blood Gases (Kpa).	1 month	After physiotherapy will take blood gases (kpa) before chest physiotherapy and perform once a month.

Trial Locations

Locations (1)

Cecilia Rodriguez; 🇸🇪 Stockholm, Sweden