Acapella With Nebulization in Normal Subjects

NCT01102166 | Completed DMC

• 1 other identifier: fabricio 01
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

This study was conducted in healthy subjects

Outcome Measures

Primary Outcomes (1)

• Radioaerosol regional pulmonary deposition

  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.

  One year

Secondary Outcomes (1)

• Spirometric values

  One year

Interventions

Acapella with nebulization OTHER

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.

Also known as: - 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

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Related Publications (3)

• Franca EE, Dornelas de Andrade AF, Cabral G, Almeida Filho P, Silva KC, Galindo Filho VC, Marinho PE, Lemos A, Parreira VF. Nebulization associated with bi-level noninvasive ventilation: analysis of pulmonary radioaerosol deposition. Respir Med. 2006 Apr;100(4):721-8. doi: 10.1016/j.rmed.2005.07.012. Epub 2005 Aug 31.

  PMID: 16139491 RESULT

• Volsko TA, DiFiore J, Chatburn RL. Performance comparison of two oscillating positive expiratory pressure devices: Acapella versus Flutter. Respir Care. 2003 Feb;48(2):124-30.

  PMID: 12556253 RESULT

• Mesquita FO, Galindo-Filho VC, Neto JL, Galvao AM, Brandao SC, Fink JB, Dornelas-de-Andrade A. Scintigraphic assessment of radio-aerosol pulmonary deposition with the acapella positive expiratory pressure device and various nebulizer configurations. Respir Care. 2014 Mar;59(3):328-33. doi: 10.4187/respcare.02291. Epub 2013 Aug 6.

  PMID: 23920214 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 13, 2010
• Study Start: August 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: April 1, 2006
• Last Updated: April 13, 2010

Record last verified: 2009-10