Acapella With Nebulization in Normal Subjects

April 12, 2010 updated by: Universidade Federal de Pernambuco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Pernambuco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

April 12, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (Estimate)

April 13, 2010

Study Record Updates

Last Update Posted (Estimate)

April 13, 2010

Last Update Submitted That Met QC Criteria

April 12, 2010

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • fabricio 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Acapella with nebulization

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe