Clinical trial NCT02261987: Resistive Inspiratory Manoeuvre as Airway Clearance Technique in Cystic Fibrosis
Official title: Role of Resistive Inspiratory Manoeuvres During Bronchial Drainage Session in Cystic Fibrosis: a Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Autogenic drainage
Resistive inspiratory manoeuvre
Computerized respiratory sounds
Airway clearance techniques
Mucus clearances
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2014-10-10
Enrollment: 32
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 typical bronchial drainage session in adults, stable CF patients.

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 a crossover randomization. Each arm of treatment will be apply only in one session. The wash-out period will be one week. Before starting the trial, all patients will perform a control session without any intervention, only the outcome measures will be assess.

During the study period the patients' pharmacological treatment remained unchanged

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Wet sputum production
timeFrame: 24 hours
Secondary outcomes:
measure: Wet sputum production
timeFrame: 30 minutes
measure: Computerized respiratory sounds
timeFrame: 30 minutes
measure: Lung function (simply spirometry)
timeFrame: 30 minutes
measure: Patients´ perception
timeFrame: 30 minutes
Other outcomes:
measure: Pulse-oximetry, heart rate and dyspnea
timeFrame: 30 minutes
Locations:
city: Madrid
country: Spain
facility: Cystic Fibrosis Association
city: Murcia
country: Spain
facility: Cystic Fibrosis Association
city: Valencia
country: Spain
facility: Cystic Fibrosis Association
city: Zaragoza
country: Spain
facility: Universidad San Jorge
Study officials:
affiliation: Universidad San Jorge
name: Beatriz Herrero, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chatham K, Ionescu AA, Nixon LS, Shale DJ. A short-term comparison of two methods of sputum expectoration in cystic fibrosis. Eur Respir J. 2004 Mar;23(3):435-9. doi: 10.1183/09031936.04.00084904.