Resistive Inspiratory Manoeuvre as Airway Clearance Technique in Cystic Fibrosis

Universidad San Jorge

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Other: Resistive inspiratory manoeuvre+autogenic drainage; Other: Resistive inspiratory manoeuvre (RIM); Other: Autogenic drainage (AD)

Study type: Interventional

Funder types: Other

Identifiers

NCT02261987

FR_FQ- 013

Details and patient eligibility

About

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.

Full 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

Enrollment: 32 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

32 participants in 3 patient groups

Autogenic drainage (AD)

Active Comparator group

Description:

Patients will perform the autogenic drainage technique following the Chevallier and Agostini recommendations.

Treatment:

Other: Autogenic drainage (AD)

Resistive inspiratory manoeuvre (RIM)

Active Comparator group

Description:

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).

Treatment:

Other: Resistive inspiratory manoeuvre (RIM)

Resistive inspiratory manoeuvre+autogenic drainage

Active Comparator group

Description:

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.

Treatment:

Other: Resistive inspiratory manoeuvre+autogenic drainage