Acapella With Nebulization in Normal Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01102166
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : April 13, 2010
Information provided by:
Universidade Federal de Pernambuco

Brief Summary:


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.

Condition or disease Intervention/treatment Phase
Healthy Other: Acapella with nebulization Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of the Use the Acapella Device in Regional Lung Deposition of Radio-aerosol
Study Start Date : August 2005
Actual Primary Completion Date : March 2006
Actual Study Completion Date : April 2006

Intervention Details:
  • Other: 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.

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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Spirometric values [ Time Frame: 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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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.