Resistive Inspiratory Manoeuvre as Airway Clearance Technique in Cystic Fibrosis

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

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Other: Autogenic drainage (AD); Other: Resistive inspiratory manoeuvre (RIM); Other: Resistive inspiratory manoeuvre+autogenic drainage

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

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Cystic Fibrosis Association
  • Murcia, Spain
    • Cystic Fibrosis Association
  • Valencia, Spain
    • Cystic Fibrosis Association
  • Zaragoza, Spain, 50830
    • Universidad San Jorge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Autogenic drainage (AD); Patients will perform the autogenic drainage technique following the Chevallier and Agostini recommendations.	Other: 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.
Active Comparator: 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).	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.
Active Comparator: 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.	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse-oximetry, heart rate and dyspnea	Safety and tolerability of session	30 minutes

Collaborators and Investigators

• Sponsor: Universidad San Jorge
• Collaborators: Cystic Fibrosis Foundation
• Investigators: Principal Investigator: Beatriz Herrero, Msc, Universidad San Jorge

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: October 7, 2014
• First Submitted That Met QC Criteria: October 7, 2014
• First Posted (Estimate): October 10, 2014

Study Record Updates

• Last Update Posted (Estimate): November 15, 2016
• Last Update Submitted That Met QC Criteria: November 11, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Airway clearance techniques; Autogenic drainage; Resistive inspiratory manoeuvre; Computerized respiratory sounds; Mucus clearances
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Respiratory Aspiration; Cystic Fibrosis
• Other Study ID Numbers: FR_FQ- 013