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Completed

NCT Number: NCT01578681

ELTGOL and Bronchiectasis. Respiratory Therapy

The ELTGOL technique improves mucociliary clearance in adult patients with bronchiectasis.

Primary objective:

-To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo.

Secondary objectives:

* To evaluate the level of knowledge of airway clearance techniques and adherence to them in patients with bronchiectasis. * To assess the side effects during the procedure: oxygen desaturation, increased dyspnea and hemoptysis.

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Key information

Conditions

Respiratory; Complications, Therapy Bronchial Diseases Bronchiectasis Respiratory Tract Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Dr. Josep Trueta

Girona, 17007, Spain

About this study

The incidence of bronchiectasis has increased in recent years resulting in greater costs, including periods of hospitalisation and the prescription of drugs.

The mucociliary clearance mechanism is impaired in these patients, and chest physiotherapy has been recommended for patients with bronchiectasis and chronic productive cough and/or evidence of mucus plugging on HRCT.

However, to date, there is insufficient evidence of benefits of chest physiotherapy through randomised controlled trials. Furthermore it rests unclear the most effective technique, the frequency and optimum duration of the RP and the most suitable variables to monitor.

A multicenter clinical trial into the efficacy of one chest physiotherapy technique in airway clearance will fill this important "gap" in the scientific evidence.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All subjects ≥ 18 years old.
  • Diagnosis of bronchiectasis using a high-resolution computed tomography (HRCT) chest scan performed in the last 2 years.
  • Clinically stable disease (defined as no requirement for antibiotics for exacerbation in the 4 weeks preceding study entry.
  • Chronic sputum expectoration >10ml/24h.

Exclusion criteria

  • Bronchiectasis secondary to cystic fibrosis.
  • Inability to perform physiotherapy techniques.
  • Inability to attend the following controls.
  • Treatment with mucolytics, DNase or hypertonic saline during the study.
  • Smokers and ex-smokers ≥ 10 pack/year.

Treatment and study plan

Low Expiration Open glottis inferolateral (ELTGOL)

Procedure

Place the affected lung in infralateral, asks the patient to make an inspiration without being forced to medium volume, and then a slow expiration with the glottis open, down to residual volume. If the therapist is present place the abdominal caudal hand at putting pressure cranial head and hand is placed over the rib cage at a pressure of closing the rib cage. Otherwise, the patient self-administered intertwining arms and abdominal rib at top exerting the same pressure. In case you have two lungs affected the art will take place on one side and then the opposite.

Other names: airway clearance

Stretching

Procedure

Patient will be instructed to do muscle stretching of the thorax

Primary outcomes

  1. To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo

    Time frame: 1 year

    The primary endpoint for the study is:

    •Sputum volume during the procedure in the second visit and 24h post treatment which is defined as the volume of mucus expectorated during the physiotherapy procedure and 24h post treatment measured by ml.

Secondary outcomes

  1. Side effects, knowledge

    Time frame: 1 year

    • To evaluate the level of knowledge of airway clearance techniques and adherence to them in patients with bronchiectasis.
    • To assess the side effects during the procedure: oxygen desaturation, increased dyspnea and hemoptysis.

Sponsors and collaborators

Lead sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Other

Collaborators

  • Sociedad Española de Neumología y Cirugía Torácica
  • Spanish Clinical Research Network - SCReN

Registry information

Official study title

Multicenter Randomized Placebo-controlled Trial to Evaluate the Efficacy of the ELTGOL Technique in the Drainage of Secretions in Patients With Bronchiectasis

Acronym: ELTGOLBQ

Important dates

Study start
2011
Primary completion
2011
Study completion
2017
First posted
Apr 17, 2012
Registry last updated
Nov 14, 2017

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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