Resistive Inspiratory Manoeuvre as Airway Clearance Technique in Cystic Fibrosis

NCT ID: NCT02261987

Last Updated: 2016-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-06-30

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

Conditions

Cystic Fibrosis

Keywords

Autogenic drainage; Resistive inspiratory manoeuvre; Computerized respiratory sounds; Airway clearance techniques; Mucus clearances

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Autogenic drainage (AD)

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

Group Type: ACTIVE_COMPARATOR

Autogenic drainage (AD)

Intervention Type: 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)

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).

Group Type: ACTIVE_COMPARATOR

Resistive inspiratory manoeuvre (RIM)

Intervention Type: 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 drainage

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.

Group Type: ACTIVE_COMPARATOR

Resistive inspiratory manoeuvre+autogenic drainage

Intervention Type: 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.

Interventions

Autogenic drainage (AD)

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.

Intervention Type: OTHER

Resistive inspiratory manoeuvre (RIM)

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.

Intervention Type: OTHER

Resistive inspiratory manoeuvre+autogenic drainage

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cystic Fibrosis Foundation

OTHER

Sponsor Role: collaborator

Universidad San Jorge

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beatriz Herrero, Msc

Role: PRINCIPAL_INVESTIGATOR

Universidad San Jorge

Locations

Cystic Fibrosis Association

Madrid, Madrid, Spain

Cystic Fibrosis Association

Murcia, Murcia, Spain

Cystic Fibrosis Association

Valencia, Valencia, Spain

Universidad San Jorge

Zaragoza, Zaragoza, Spain

Countries

Spain

References

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.

Reference Type: RESULT

PMID: 15065835 (View on PubMed)

Other Identifiers

FR_FQ- 013

Identifier Type: -

Identifier Source: org_study_id