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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01300403
Other study ID # 02/2009
Secondary ID
Status Completed
Phase N/A
First received February 18, 2011
Last updated February 18, 2011
Start date June 2009
Est. completion date August 2010

Study information

Verified date September 2010
Source Universidade Federal do Rio de Janeiro
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

This study aimed to evaluate the acute physiological effects of expiration with the glottis open in lateral posture (ELTGOL) and Flutter valve in dynamic and static lung volumes in patients with bronchiectasis and, secondarily, to study the effect of these techniques in sputum production.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

Patients with clinical and radiological criteria of bronchiectasis

Exclusion Criteria:

- heart failure

- pneumonia

- chest pain

- inability to perform the procedures

- asthma

- cystic fibrosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Flutter valve
Flutter valve is a physiotherapy device commonly used for the treatment of pulmonary hypersecretive conditions. The patients is taught to exhale through the device, producing positive expiratory pressure and flow oscillations. In this study the intervention took 15 minutes. During this period the patients were free to cough.
expiration with the glottis open in lateral posture (ELTGOL)
This technique is a maneuver of slow expiration with the glottis open, with the subject in lateral posture. The patients performed three sets of 10 repetitions in left and right lateral decubitus.
Control
Patients were instructed to stay comfortably seated during 15 minutes. After this period they were stimulated to cough during a five minutes period.

Locations

Country Name City State
Brazil Hospital Universitário Pedro Ernesto Rio de Janeiro

Sponsors (2)

Lead Sponsor Collaborator
Universidade Federal do Rio de Janeiro Centro Universitário Augusto Motta

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dynamic and static lung volumes Dynamic and static lung volumes were assessed by forced spirometry and plethysmography. In the week 1, 2 and 3. Before (baseline) and after each intervention. No
Secondary Sputum production The expectorated secretions were collected using a sputum trap and quantificated by its dry weight. Sputum was colected during the interventions No
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