Overview

This trial is active, not recruiting.

Conditions respiratory; complications, therapy, bronchiectasis
Treatments low expiration open glottis inferolateral (eltgol), stretching
Sponsor Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Collaborator Spanish Clinical Research Network - CAIBER
Start date September 2011
End date September 2011
Trial size 154 participants
Trial identifier NCT01578681, 08/10

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
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.
low expiration open glottis inferolateral (eltgol) airway clearance
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.
(Placebo Comparator)
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.
stretching stretching
Patient will be instructed to do muscle stretching of the thorax

Primary Outcomes

Measure
To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo
time frame: 1 year

Secondary Outcomes

Measure
Side effects, knowledge
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 95 years old.

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.

Additional Information

Official title Multicenter Randomized Placebo-controlled Trial to Evaluate the Efficacy of the ELTGOL Technique in the Drainage of Secretions in Patients With Bronchiectasis
Principal investigator Montserrat V Relat, Doctor
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta.