Non Invasive Ventilation as Airway Clearance in Patients With Cystic Fibrosis
Study of Non Invasive Ventilation With High Pressure as Airways Clearance Technique in Adults Patients With Cystic Fibrosis
1 other identifier
interventional
32
1 country
1
Brief Summary
With the use of Non invasive ventilation the patients with cystic fibrosis will have better lung function (FEV1).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedFirst Posted
Study publicly available on registry
March 11, 2014
CompletedResults Posted
Study results publicly available
July 3, 2014
CompletedJuly 16, 2014
July 1, 2014
11 months
November 16, 2012
March 11, 2014
July 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Blood Gases:1 Month After Chest Physiotherapy Will Take Blood Gases (Kpa).
1 month
Study Arms (2)
Bilevel
EXPERIMENTALBilevel, 3 months. The treatment was performed twice a day, 1 hour each treatment.
PEP mask
ACTIVE COMPARATORPEP mask, 3 months. The treatment was performed twice a day, 1 hour each treatment.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with CF older than 18 years
- FEV1 between 20% and 69% of predictive.
- No acute exacerbation.
- No Burkhordelia Cepacia/MRSA colonization.
You may not qualify if:
- Children under 18 year
- acute exacerbation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska University Hospitallead
- Karolinska Institutetcollaborator
Study Sites (1)
Cecilia Rodriguez
Stockholm, Stockholm County, 14178, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Maria Cecilia Rodriguez Hortal
- Organization
- Karolinska University Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Cecilia Rodriguez, Physio
Karolinska Institutet
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist Physiotherapist
Study Record Dates
First Submitted
November 16, 2012
First Posted
March 11, 2014
Study Start
October 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
July 16, 2014
Results First Posted
July 3, 2014
Record last verified: 2014-07