Resistive Inspiratory Manoeuvre as Airway Clearance Technique in Cystic Fibrosis

Study Overview
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Brief Summary
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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
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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

Official Title
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Role of Resistive Inspiratory Manoeuvres During Bronchial Drainage Session in Cystic Fibrosis: a Randomized Crossover Trial

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Other: Autogenic drainage (AD)
* Other: Resistive inspiratory manoeuvre (RIM)
* Other: Resistive inspiratory manoeuvre+autogenic drainage


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Autogenic drainage (AD)<br>Patients will perform the autogenic drainage technique following the Chevallier and Agostini recommendations. | Other: Autogenic drainage (AD)<br>* It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order.<br>|
| Active Comparator: Resistive inspiratory manoeuvre (RIM)<br>Patients will perform the repetitive inspiratory manoeuvers by breathing through a fixed resistance (Power Breathe device, model KH1) . Each session will comprise to cycles of 5 inspiratory breaths (60% of maximal inspiratory pressure). Patients will be stay in both lateral decubitus position (15 min per side). | Other: Resistive inspiratory manoeuvre (RIM)<br>* It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order.<br>|
| Active Comparator: Resistive inspiratory manoeuvre+autogenic drainage<br>First, patients will perform the resistive inspiratory manoeuvre during 10 minutes (5 min per side). Right after, patients will perform the autogenic drainage during 20 minutes.The instructions will be similar to described previously. | Other: Resistive inspiratory manoeuvre+autogenic drainage<br>* It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wet sputum production | 24h wet sputum production (g) after bronchial drainage session | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wet sputum production | Wet sputum production (g) during bronchial drainage session | 30 minutes | 
| Computerized respiratory sounds | Adventitous respiratory sounds: crackles and wheezes | 30 minutes | 
| Lung function (simply spirometry) | Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75 | 30 minutes | 
| Patients´ perception | Visual analogical scale | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autogenic drainage, Resistive inspiratory manoeuvre, Computerized respiratory sounds, Airway clearance techniques, Mucus clearances