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Resistive Inspiratory Manoeuvre as Airway Clearance Technique in Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Autogenic drainage (AD)
Resistive inspiratory manoeuvre (RIM)
Resistive inspiratory manoeuvre+autogenic drainage
Sponsored by
Universidad San Jorge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Autogenic drainage, Resistive inspiratory manoeuvre, Computerized respiratory sounds, Airway clearance techniques, Mucus clearances

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Cystic Fibrosis Association
  • Cystic Fibrosis Association
  • Cystic Fibrosis Association
  • Universidad San Jorge

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Autogenic drainage (AD)

Resistive inspiratory manoeuvre (RIM)

Resistive inspiratory manoeuvre+autogenic drainage

Arm Description

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

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 7, 2014
Last Updated
November 11, 2016
Sponsor
Universidad San Jorge
Collaborators
Cystic Fibrosis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02261987
Brief Title
Resistive Inspiratory Manoeuvre as Airway Clearance Technique in Cystic Fibrosis
Official Title
Role of Resistive Inspiratory Manoeuvres During Bronchial Drainage Session in Cystic Fibrosis: a Randomized Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad San Jorge
Collaborators
Cystic Fibrosis Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Autogenic drainage, Resistive inspiratory manoeuvre, Computerized respiratory sounds, Airway clearance techniques, Mucus clearances

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autogenic drainage (AD)
Arm Type
Active Comparator
Arm Description
Patients will perform the autogenic drainage technique following the Chevallier and Agostini recommendations.
Arm Title
Resistive inspiratory manoeuvre (RIM)
Arm Type
Active Comparator
Arm 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).
Arm Title
Resistive inspiratory manoeuvre+autogenic drainage
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Autogenic drainage (AD)
Intervention Description
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
Intervention Name(s)
Resistive inspiratory manoeuvre (RIM)
Intervention Description
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
Intervention Name(s)
Resistive inspiratory manoeuvre+autogenic drainage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wet sputum production
Description
24h wet sputum production (g) after bronchial drainage session
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Wet sputum production
Description
Wet sputum production (g) during bronchial drainage session
Time Frame
30 minutes
Title
Computerized respiratory sounds
Description
Adventitous respiratory sounds: crackles and wheezes
Time Frame
30 minutes
Title
Lung function (simply spirometry)
Description
Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75
Time Frame
30 minutes
Title
Patients´ perception
Description
Visual analogical scale
Time Frame
30 minutes
Other Pre-specified Outcome Measures:
Title
Pulse-oximetry, heart rate and dyspnea
Description
Safety and tolerability of session
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz Herrero, Msc
Organizational Affiliation
Universidad San Jorge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cystic Fibrosis Association
City
Madrid
Country
Spain
Facility Name
Cystic Fibrosis Association
City
Murcia
Country
Spain
Facility Name
Cystic Fibrosis Association
City
Valencia
Country
Spain
Facility Name
Universidad San Jorge
City
Zaragoza
ZIP/Postal Code
50830
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
15065835
Citation
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.
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Resistive Inspiratory Manoeuvre as Airway Clearance Technique in Cystic Fibrosis

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