3 Airway Clearance Techniques in Non Cystic Fibrosis Bronchiectasis

NCT01854788 | Completed

• 1 other identifier: Uniko2010.01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Study design: a randomized, crossover trial. Each patient performed three different airway clearance techniques (Autogenic drainage, slow expiratory with glottis opened in lateral posture \[ELTGOL\], temporary- positive expiratory pressure \[T-PEP\] with not similar autonomy degree in a randomized order. Each technique were applied in 3 sessions during one week at alternate days (Monday /Wednesday/Friday or Tuesday/Thursday/Saturday). The time spent in each bronchial session was 40 minutes. Seven days were the wash-out time period between the different techniques.

Conditions

Bronchiectasis

Keywords

Airway clearance techniques; Mucus clearance; Chest physiotherapy; Autogenic drainage; Slow expiration with glottis opened in lateral posture(ELTGOL); Temporary-positive expiratory pressure (T-PEP); Non cystic fibrosis bronchiectasis

Outcome Measures

Primary Outcomes (2)

• Weight of sputum expectorated during each airway clearance therapy session

  Wet weight sputum production were recollected in one pre-weighted containers. It was measured in grams.

  40 minutes

• Weight of sputum expectorated 24 hours post each bronchial session

  Wet weight sputum production were recollected in one pre-weighted containers. It was measured in grams.

  24 hours

Secondary Outcomes (2)

• Saint George Respiratory Questionnaire (SGRQ)

  Change from baseline at 5 weeks

• Leicester Cough Questionnaire (LCQ)

  Changes from baseline arm to 1 week

Other Outcomes (2)

• Lung function measured by simple spirometry: forced expiratory volume in 1 second, Forced vital capacity, Forced expiratory flow 25-75

  Change from baseline arm to 1 week

• Likert test

  Change from baseline arm to 1 week

Study Arms (3)

Autogenic drainage

ACTIVE COMPARATOR

All patients performed all interventions in a randomized order. Each technique was applied in 3 non consecutively sessions during one week. The time spent during the session was 40 minutes

Other: Autogenic drainage

Slow expiration with glottis opened in lateral posture

ACTIVE COMPARATOR

All patients performed all interventions in a randomized order.Each technique was applied in 3 non consecutively sessions during one week. The time spent during the session was 40 minutes

Other: Slow expiration with glottis opened in lateral posture

Temporary-Positive Expiratory Pressure

ACTIVE COMPARATOR

All patients performed all interventions in a randomized order. Each technique was applied in 3 non consecutively sessions during one week. The time spent during the session was 40 minutes

Other: Temporary-positive expiratory pressure

Interventions

Autogenic drainage OTHER

It was performed following J. Chevallier recommendations.In this trial it was considered a self-administrated technique because physiotherapist only gave oral advice in order to ensure a correct performance of the technique.

Autogenic drainage

Slow expiration with glottis opened in lateral posture OTHER

It was performed following Postiaux´s recommendations. In this trial the technique was considered active-assisted because the physiotherapy played a role important in their execution.

Also known as: Slow expiratory with glotis opened in lateral position

Slow expiration with glottis opened in lateral posture

Temporary-positive expiratory pressure OTHER

The diaphragmatic breathing was required for this technique whereas patients remain seated in front of the device with a nose clip. The inspiratory /expiratory ratio was 1:2.It was taken into account as a device-administrated technique for this trial.

Temporary-Positive Expiratory Pressure

Eligibility Criteria

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

You may qualify if:

• \- Non Cystic Fibrosis bronchiectasis diagnosed by High Resolution Computed Tomographic
• \- Mean sputum production ≥ 15 ml /24h
• \- Clinical stability in the last 6 weeks
• \- Not carrying out regular chest physiotherapy
• \- Forced expiratory volume in 1 second ≥ 30% pred. ; Forced Vital Capacity ≥ 45% pred. and peak expiratory flow \>270 L/s

You may not qualify if:

• \- Smoker or non-smoker form less than 2 years
• \- Cystic fibrosis
• \- Active tuberculosis or sarcoidosis

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital CLinic

Barcelona, Barcelona, 08029, Spain

Location

Related Publications (2)

• Herrero-Cortina B, Alcaraz-Serrano V, Torres A, Polverino E. Reliability and Minimum Important Difference of Sputum Weight in Bronchiectasis. Respir Care. 2020 Oct;65(10):1478-1487. doi: 10.4187/respcare.07175. Epub 2020 Feb 18.

  PMID: 32071136 DERIVED

• Herrero-Cortina B, Vilaro J, Marti D, Torres A, San Miguel-Pagola M, Alcaraz V, Polverino E. Short-term effects of three slow expiratory airway clearance techniques in patients with bronchiectasis: a randomised crossover trial. Physiotherapy. 2016 Dec;102(4):357-364. doi: 10.1016/j.physio.2015.07.005. Epub 2015 Dec 1.

  PMID: 26712530 DERIVED

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Beatriz Herrero, Phy

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• Eva Polverino, Doctor

  Hospital Clinic of Barcelona

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: May 16, 2013
• Study Start: September 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 16, 2013

Record last verified: 2013-05

Locations

ES (1)