Acapella With Nebulization in Normal Subjects

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT01102166
• Lead Sponsor: Universidade Federal de Pernambuco

Brief Summary

Background:

Devices used to facilitate mucus mobilization have been target of several controversies and mainly a few scientific studies that endorse the use of those equipments. According to the principle of acapella® device, it should be used concomitant with nebulization aiming to optimize its performance in bronchial hygiene.

Aims: To assess the effect of acapella® device application in the radioaerosol regional pulmonary deposition through pulmonary scintigraphy in normal subjects.

Materials and method: 10 health individuals, males and mean age of 24,4 ± 2,2 years participated in this study during the three phases of this research: 1st phase were done with nebulization through acapella® device, attached in the final branch according to manufacturer recommendation; in 2nd phase a ¨T¨tube connector were adapted, being nebulizer attached to the mouthpiece and in 3rd phase nebulization were performance through the mouthpiece as routinely used in aerosoltherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Primary Completion: 2006-03
• Study Completion: 2006-04
• Status Verified: 2009-10
• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-12
• Last Update Submitted: 2010-04-12
• Study First Posted: 2010-04-13
• Last Update Posted: 2010-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Age between 18 and 65 years
• Performed spirometry
• According to the criteria of the Guidelines for Pulmonary Function-2002 published by the official organ of the Brazilian Society of Thoracic

Exclusion Criteria

• Presence of pulmonary pathology;
• Neurological diseases and body temperature greater than 37 º C during the initial evaluation and during intervention
• Respiratory rate (RR) greater than 35ipm.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Radioaerosol regional pulmonary deposition	One year	For analysis of lung deposition of radio-aerosol in the different lung areas were delineated regions of interest (ROIs), one for each lung, called the right posterior and left posterior. To analyze this deposition, the lung was divided into regions: upper, middle and bottom, and peripheral, central and intermediate.

Secondary Outcome Measures

Name	Time	Method
Spirometric values	One year	The procedure was performed with the nose occluded by a nose clip and spirometric data were considered the PFE,FVC and FEV1. We used the protocol of Pereira 3 maneuvers being conducted with an interval between the measurements of one minute. According to the American Thoracic Society, as a criterion for inclusion was considering a variation of less than 0.2 L between the tests and is considered the best of three values.