Acapella With Nebulization in Normal Subjects

This study has been completed.
Sponsor:
Information provided by:
Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier:
NCT01102166
First received: April 12, 2010
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Healthy
Other: Acapella with nebulization

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of the Use the Acapella Device in Regional Lung Deposition of Radio-aerosol

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Pernambuco:

Primary Outcome Measures:
  • Radioaerosol regional pulmonary deposition [ Time Frame: One year ] [ Designated as safety issue: No ]
    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:
  • Spirometric values [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Enrollment: 10
Study Start Date: August 2005
Study Completion Date: April 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
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)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Armele Dornelas de Andrade, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT01102166     History of Changes
Other Study ID Numbers: fabricio 01
Study First Received: April 12, 2010
Last Updated: April 12, 2010
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Federal de Pernambuco:
This study was conducted in healthy subjects

ClinicalTrials.gov processed this record on July 26, 2014