Non Invasive Ventilation as Airway Clearance in Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Study of Non Invasive Ventilation With High Pressure as Airways Clearance Technique in Adults Patients With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083263
• Other study ID #: CF2012-1
• Status: Completed
• Phase: N/A
• First received: November 16, 2012
• Last updated: July 3, 2014
• Start date: October 2012
• Est. completion date: September 2013

Study information

• Verified date: July 2014
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• Bilevel
3 months
• PEP mask
3 months

Locations

Country	Name	City	State
Sweden	Cecilia Rodriguez	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Function: Lung Clearance Index	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.	up to 3 months	Yes
Secondary	Blood Gases:1 Month After Chest Physiotherapy Will Take Blood Gases (Kpa).	After physiotherapy will take blood gases (kpa) before chest physiotherapy and perform once a month.	1 month	Yes