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Completed

NCT Number: NCT02261987

Resistive Inspiratory Manoeuvre as Airway Clearance Technique in Cystic Fibrosis

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cystic Fibrosis Association, Madrid, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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+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.

Primary outcomes

  1. Wet sputum production

    Time frame: 24 hours

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

Secondary outcomes

  1. Wet sputum production

    Time frame: 30 minutes

    Wet sputum production (g) during bronchial drainage session

  2. Computerized respiratory sounds

    Time frame: 30 minutes

    Adventitous respiratory sounds: crackles and wheezes

  3. Lung function (simply spirometry)

    Time frame: 30 minutes

    Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75

  4. Patients´ perception

    Time frame: 30 minutes

    Visual analogical scale

Other outcomes

  1. Pulse-oximetry, heart rate and dyspnea

    Time frame: 30 minutes

    Safety and tolerability of session

Sponsors and collaborators

Lead sponsor

Universidad San Jorge

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 10, 2014
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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