ELTGOL and Bronchiectasis. Respiratory Therapy

Bronchiectasis Clinical Trial

— ELTGOLBQ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578681
• Other study ID #: 08/10
• Status: Completed
• Phase: N/A
• First received: April 13, 2012
• Last updated: November 13, 2017
• Start date: September 2011
• Est. completion date: March 2017

Study information

• Verified date: November 2017
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2017
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis
• Respiratory; Complications, Therapy

Intervention

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.
• Stretching
Patient will be instructed to do muscle stretching of the thorax

Locations

Country	Name	City	State
Spain	Hospital Universitari Dr. Josep Trueta	Girona

Sponsors (3)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta	Sociedad Española de Neumología y Cirugía Torácica, Spanish Clinical Research Network - CAIBER

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo	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.	1 year
Secondary	Side effects, knowledge	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.	1 year