Resistive Inspiratory Manoeuvre as Airway Clearance Technique in Cystic Fibrosis

NCT02261987 | Completed DMC

• 1 other identifier: FR_FQ- 013
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

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.

Conditions

Cystic Fibrosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Wet sputum production

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

  24 hours

Secondary Outcomes (4)

• Wet sputum production

  30 minutes

• Computerized respiratory sounds

  30 minutes

• Lung function (simply spirometry)

  30 minutes

• Patients´ perception

  30 minutes

Other Outcomes (1)

• Pulse-oximetry, heart rate and dyspnea

  30 minutes

Study Arms (3)

Autogenic drainage (AD)

ACTIVE COMPARATOR

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

Other: Autogenic drainage (AD)

Resistive inspiratory manoeuvre (RIM)

ACTIVE COMPARATOR

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)

Resistive inspiratory manoeuvre+autogenic drainage

ACTIVE COMPARATOR

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

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.

Autogenic drainage (AD)

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 (RIM)

Resistive inspiratory manoeuvre+autogenic drainage 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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universidad San Jorge: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (4)

Cystic Fibrosis Association

Madrid, Madrid, Spain

Location

Cystic Fibrosis Association

Murcia, Murcia, Spain

Location

Cystic Fibrosis Association

Valencia, Valencia, Spain

Location

Universidad San Jorge

Zaragoza, Zaragoza, 50830, Spain

Location

Related Publications (1)

• 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.

  PMID: 15065835 RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Beatriz Herrero, Msc

  Universidad San Jorge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 10, 2014
• Study Start: November 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

ES (4)