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Non Invasive Ventilation as Airway Clearance in Patients With Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02083263
Recruitment Status : Completed
First Posted : March 11, 2014
Results First Posted : July 3, 2014
Last Update Posted : July 16, 2014
Karolinska Institutet
Information provided by (Responsible Party):
Cecilia Rodriguez, Karolinska University Hospital

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

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Device: Bilevel Device: PEP mask Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Non Invasive Ventilation With High Pressure as Airways Clearance Technique in Adults Patients With Cystic Fibrosis
Study Start Date : October 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02083263

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Cecilia Rodriguez
Stockholm, Sweden, 14178
Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
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Principal Investigator: Cecilia Rodriguez, Physio Karolinska Institutet
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Responsible Party: Cecilia Rodriguez, Specialist Physiotherapist, Karolinska University Hospital Identifier: NCT02083263    
Other Study ID Numbers: CF2012-1
First Posted: March 11, 2014    Key Record Dates
Results First Posted: July 3, 2014
Last Update Posted: July 16, 2014
Last Verified: July 2014
Keywords provided by Cecilia Rodriguez, Karolinska University Hospital:
Lung function
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases