Non Invasive Ventilation as Airway Clearance in Patients With Cystic Fibrosis

Karolinska University Hospital

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Device: Bilevel; Device: PEP mask

Study type: Interventional

Funder types: Other

Identifiers

NCT02083263

CF2012-1

Details and patient eligibility

About

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

Full description

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Bilevel

Experimental group

Description:

Bilevel, 3 months. The treatment was performed twice a day, 1 hour each treatment.

Treatment:

Device: Bilevel

PEP mask

Active Comparator group

Description:

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

Treatment:

Device: PEP mask