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ELTGOL and Bronchiectasis. Respiratory Therapy (ELTGOLBQ)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01578681
First Posted: April 17, 2012
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Spanish Clinical Research Network - CAIBER
Sociedad Española de Neumología y Cirugía Torácica
Information provided by (Responsible Party):
Dr. Montserrat Vendrell Relat, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
April 13, 2012
April 17, 2012
November 14, 2017
September 2011
September 2011   (Final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01578681 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
ELTGOL and Bronchiectasis. Respiratory Therapy
Multicenter Randomized Placebo-controlled Trial to Evaluate the Efficacy of the ELTGOL Technique in the Drainage of Secretions in Patients With Bronchiectasis

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Respiratory; Complications, Therapy
  • Bronchiectasis
  • Procedure: Low Expiration Open glottis inferolateral (ELTGOL)
    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 Name: airway clearance
  • Procedure: Stretching
    Patient will be instructed to do muscle stretching of the thorax
  • Active Comparator: Airway clearance, bronchiectasis

    The patient would be selected randomly to one of the two groups (intervention or placebo). And follow up for one year with regular visits with the physician and the respiratory therapist.

    Each patient will be visited 7 times. At each visit all the variable will be registered. Patient will have also a personal registration diary.

    Intervention: Procedure: Low Expiration Open glottis inferolateral (ELTGOL)
  • Placebo Comparator: bronchiectasis, stretching

    The patient would be selected randomly to one of the two groups (intervention or placebo). And follow up for one year with regular visits with the physician and the respiratory therapist.

    Each patient will be visited 7 times. At each visit all the variable will be registered. Patient will have also a personal registration diary.

    Intervention: Procedure: Stretching
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
March 2017
September 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 95 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01578681
08/10
No
Not Provided
Not Provided
Dr. Montserrat Vendrell Relat, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
  • Spanish Clinical Research Network - CAIBER
  • Sociedad Española de Neumología y Cirugía Torácica
Principal Investigator: Montserrat V Relat, Doctor Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP