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Acapella With Nebulization in Normal Subjects

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01102166
Enrollment
10
Registered
2010-04-13
Start date
2005-08-31
Completion date
2006-04-30
Last updated
2010-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

This study was conducted in healthy subjects

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.

Interventions

OTHERAcapella 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.

Sponsors

Universidade Federal de Pernambuco
Lead SponsorOTHER

Study design

Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frameDescription
Radioaerosol regional pulmonary depositionOne yearFor 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

MeasureTime frameDescription
Spirometric valuesOne yearThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026