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Non Invasive Ventilation as Airway Clearance in Patients With Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Bilevel
PEP mask
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Lung function

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cecilia Rodriguez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bilevel

PEP mask

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 16, 2012
Last Updated
July 3, 2014
Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02083263
Brief Title
Non Invasive Ventilation as Airway Clearance in Patients With Cystic Fibrosis
Official Title
Study of Non Invasive Ventilation With High Pressure as Airways Clearance Technique in Adults Patients With Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Lung function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilevel
Arm Type
Experimental
Arm Description
Bilevel, 3 months. The treatment was performed twice a day, 1 hour each treatment.
Arm Title
PEP mask
Arm Type
Active Comparator
Arm Description
PEP mask, 3 months. The treatment was performed twice a day, 1 hour each treatment.
Intervention Type
Device
Intervention Name(s)
Bilevel
Intervention Description
3 months
Intervention Type
Device
Intervention Name(s)
PEP mask
Intervention Description
3 months
Primary Outcome Measure Information:
Title
Lung Function: Lung Clearance Index
Description
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.
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Blood Gases:1 Month After Chest Physiotherapy Will Take Blood Gases (Kpa).
Description
After physiotherapy will take blood gases (kpa) before chest physiotherapy and perform once a month.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilia Rodriguez, Physio
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cecilia Rodriguez
City
Stockholm
ZIP/Postal Code
14178
Country
Sweden

12. IPD Sharing Statement

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Non Invasive Ventilation as Airway Clearance in Patients With Cystic Fibrosis

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