Acapella With Nebulization in Normal Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Acapella with nebulization

1. st Phase In this phase the jet nebulizer was connected to the branch end of the Acapella according to manufacturer's recommendations.

The volunteer did the radio-aerosol inhalation to obtain images of the lung fields scintigraphy static during the period of 300 seconds using an array of at 256x256x16 incidence later, as that encompasses most incidence of lung volume.
2. nd Phase The experimental procedure of this phase was similar to the 1st stage, but what differed was it made an adjustment by placing a pipe "T" between the mouthpiece and the device Acapella so that the aerosol would be inhaled not pass through the device.

Stage 3 This stage was considered phase control since the aerosol inhalation was performed through the mouthpiece connected directly to the nebulizer as is routinely used in clinical practice as illustrated. The procedure of this phase followed the same protocol of previous phases.

Intervention Type OTHER

Other Intervention Names

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- Acapella ® device (DHD Healthcare, wampsville, New York) - Activity standardized 25mCI and after the inhalation chamber were placed on scintigraphy (FORTE of Adac Laboratories)

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes