Status:
COMPLETED
Resistive Inspiratory Manoeuvre as Airway Clearance Technique in Cystic Fibrosis
Lead Sponsor:
Universidad San Jorge
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
This trial aims to analyze whether the resistive inspiratory manoeuvre (RIM) performed previously to autogenic drainage (AD) technique improves the effectiveness in terms of mucus clearance during a t...
Detailed Description
It is a multicenter study. 4 different Spain Cystic Fibrosis Foundations are included in the study (Madrid, Valencia, Murcia and Aragón). All patients will perform three different arms of treatment in...
Eligibility Criteria
Inclusion
- Cystic Fibrosis (CF) diagnosed ( established by genotype or sweat sodium\>70 mmol/l or sweat chloride of\>60 mmol/l)
- Clinically stable at time of study entry (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 wk);
- Chronic sputum production, at least ≥ 15 ml /24h
- Familiar and trained in the use of autogenic drainage technique (at least 6 months) and resistive inspiratory manoeuvre (at least three previous sessions)
- To be able to provide written, informed consent
Exclusion
- Lung function: Forced expiratory volume in 1 second \< 30 % pred . ; Forced vital capacity \< 40 % pred.
- Active haemoptysis during the previous month
- Supplemental oxygen or non-invasive ventilation (NIV)
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02261987
Start Date
November 1 2014
End Date
June 1 2016
Last Update
November 15 2016
Active Locations (4)
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1
Cystic Fibrosis Association
Madrid, Madrid, Spain
2
Cystic Fibrosis Association
Murcia, Murcia, Spain
3
Cystic Fibrosis Association
Valencia, Valencia, Spain
4
Universidad San Jorge
Zaragoza, Zaragoza, Spain, 50830