Non Invasive Ventilation as Airway Clearance in Patients With Cystic Fibrosis

July 3, 2014 updated by: Cecilia Rodriguez, Karolinska University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 14178
        • Cecilia Rodriguez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bilevel
Bilevel, 3 months. The treatment was performed twice a day, 1 hour each treatment.
Device: Bilevel
3 months
Active Comparator: PEP mask
PEP mask, 3 months. The treatment was performed twice a day, 1 hour each treatment.
Device: PEP mask
3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

Karolinska Institutet

Investigators

  • Principal Investigator: Cecilia Rodriguez, Physio, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

November 16, 2012

First Submitted That Met QC Criteria

March 10, 2014

First Posted (Estimate)

March 11, 2014

Study Record Updates

Last Update Posted (Estimate)

July 16, 2014

Last Update Submitted That Met QC Criteria

July 3, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CF2012-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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