Resistive Inspiratory Manoeuvre as Airway Clearance Technique in Cystic Fibrosis

N/ACompletedNCT02261987

Universidad San Jorge32 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cystic Fibrosis

Interventions

Autogenic drainage (AD)OTHER

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.

Resistive inspiratory manoeuvre (RIM)OTHER

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.

Resistive inspiratory manoeuvre+autogenic drainageOTHER

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.

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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)

Locations (4)

Cystic Fibrosis Association

Madrid, Madrid, Spain

Cystic Fibrosis Association

Murcia, Murcia, Spain

Cystic Fibrosis Association

Valencia, Valencia, Spain

Universidad San Jorge

Zaragoza, Zaragoza, Spain

Outcomes

Primary Outcomes

Wet sputum production

24h wet sputum production (g) after bronchial drainage session

Time frame: 24 hours

Secondary Outcomes

Wet sputum production

Wet sputum production (g) during bronchial drainage session

Time frame: 30 minutes

Computerized respiratory sounds

Adventitous respiratory sounds: crackles and wheezes

Time frame: 30 minutes

Lung function (simply spirometry)

Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75

Time frame: 30 minutes

Patients´ perception

Visual analogical scale

Time frame: 30 minutes

Data from ClinicalTrials.gov

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