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Analysis of Deposition With Nebulizers Membrane

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ClinicalTrials.gov Identifier: NCT02501655
Recruitment Status : Unknown
Verified July 2015 by Daniella Cunha Brandao, Universidade Federal de Pernambuco.
Recruitment status was:  Recruiting
First Posted : July 17, 2015
Last Update Posted : July 17, 2015
Sponsor:
Information provided by (Responsible Party):
Daniella Cunha Brandao, Universidade Federal de Pernambuco

Brief Summary:
BACKGROUND: Mesh nebulizers (MN) have lower residual volume and increased inhaled dose compared to jet nebulizers (JN) per in vitro and animal models. The aim of this study was to compare radioaerosol deposition using MN and JN in healthy subjects, using 2-D planar scintigraphy. METHODS: A randomized trial in 6 normal subjects (4 female, 2 male) inhaled 99mTc-DTPA with an activity of 1 mCi with the normal saline to a total dose of 4 mL with JN (Misty Max, Air Life, Yorba Linda, USA) oxygen flow of 8 L / min and 1.5 mL with MN (Aeroneb Solo with Ultra adapter; Aerogen Galway, Ireland). Scintigraphy was used to determine distribution of deposition and mass balance between compartments.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Device: phase 1 - jet nebulizer Device: Phase 2- mesh nebulizer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ANALYSIS OF DEPOSITION RADIOAEROSOL NEBULIZERS MEMBRANE IN HEALTHY SUBJECTS
Study Start Date : July 2015
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2015

Arm Intervention/treatment
Active Comparator: Phase 1
Jet Nebulizer - control group
Device: Phase 2- mesh nebulizer
Aerosol generators diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) mixed with 0.9% saline solution with a total volume of 2 ml using vibrating mesh inhaler with valved chamber adapter (Aerogen Solo with Ultra Adapter, Aerogen Ltd).

Experimental: Phase 2
Mesh nebulizers
Device: phase 1 - jet nebulizer
Aerosol generators diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) mixed with 0.9% saline solution with a total volume of 4 ml using jet nebulizer (NS - mark) and 8l/min of the oxygen




Primary Outcome Measures :
  1. radioaerosol deposition index into the lungs [ Time Frame: 1 month ]
    Immediately after inhalation, participants sat in a chair with the back positioned in front to the gamma camera (STARCAM 3200 GE, California, USA) to obtain radioactivity counts from the posterior thorax during a period of 300 seconds on a matrix of 256 X 256. After, participants were positioned sitting in front to the gama camera to obtain images from face. Then, the same procedure was performed to analysis deposition in the nebulizer, circuits, inspiratory filter, expiratory filter and face mask. Counts representing stomach were obtained from posterior thorax and corrections for decay of technetium were used to during extrapulmonary measurements



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The study inclusion critera was healthy adults of both sexes, between 18 to 65 years, without history of lung disease or smoking, with forced vital capacity (FVC) or forced expiratory volume in the first second (FEV1) greater or equal to 80% of predicted values (Pereira et al., 1992), ability to follow and retain verbal commands while able and willing to provide signed consent to participate in this study.

Exclusion Criteria:

  • Participants were excluded if they have been diagnosed with a lung disease, current smoker, unable to understand and follow the procedures and pregnant or unable to tolerate nebulization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501655


Locations
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Brazil
Hospital das Clínicas de Pernambuco Recruiting
Recife, Pernambuco, Brazil, 50670-901
Contact: Luciana Alcoforado       alcoforadoluciana@gmail.com   
Sponsors and Collaborators
Daniella Cunha Brandao
Investigators
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Principal Investigator: Luciana Alcoforado UFPE
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Responsible Party: Daniella Cunha Brandao, Daniella Cunha Brandão, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02501655    
Other Study ID Numbers: Luciana doutorado 01
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: July 17, 2015
Last Verified: July 2015