ELTGOL and Bronchiectasis. Respiratory Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Respiratory; Complications, Therapy, Bronchiectasis

Intervention / Treatment
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* Procedure: Low Expiration Open glottis inferolateral (ELTGOL)
* Procedure: Stretching


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Airway clearance, bronchiectasis<br>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. | Procedure: Low Expiration Open glottis inferolateral (ELTGOL)<br>* 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.<br>* Other names: airway clearance;|
| Placebo Comparator: bronchiectasis, stretching<br>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. | Procedure: Stretching<br>* Patient will be instructed to do muscle stretching of the thorax<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bronchiectasis, respiratory therapy, airway clearance