Analysis of Deposition With Nebulizers Membrane

NCT02501655 | Unknown DMC

• 1 other identifier: Luciana doutorado 01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• radioaerosol deposition index into the lungs

  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

  1 month

Study Arms (2)

Phase 1

ACTIVE COMPARATOR

Jet Nebulizer - control group

Device: Phase 2- mesh nebulizer

Phase 2

EXPERIMENTAL

Mesh nebulizers

Device: phase 1 - jet nebulizer

Interventions

phase 1 - jet nebulizer DEVICE

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

Phase 2

Phase 2- mesh nebulizer DEVICE

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).

Phase 1

Eligibility Criteria

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daniella Cunha Brandao: lead

Study Sites (1)

Hospital das Clínicas de Pernambuco

Recife, Pernambuco, 50670-901, Brazil

RECRUITING

Study Officials

• Luciana Alcoforado

  UFPE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Daniella Cunha Brandão

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 17, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: July 17, 2015

Record last verified: 2015-07

Locations

BR (1)