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Clinical Trials/NCT01102166
NCT01102166CompletedNot Applicable

Effect of the Use the Acapella Device in Regional Lung Deposition of Radio-aerosol

Universidade Federal de Pernambuco0 sites10 target enrollmentStarted: August 2005Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Primary Endpoint
Radioaerosol regional pulmonary deposition

Study Overview

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.

Study Design

Study Type
Interventional
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Radioaerosol regional pulmonary deposition

Time Frame: 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 Outcomes

  • Spirometric values(One year)

Investigators

Sponsor Class
Other

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