Analysis of Deposition With Nebulizers Membrane

Healthy Volunteers Clinical Trial

Official title:

ANALYSIS OF DEPOSITION RADIOAEROSOL NEBULIZERS MEMBRANE IN HEALTHY SUBJECTS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02501655
• Other study ID #: Luciana doutorado 01
• Status: Recruiting
• Phase: N/A
• First received: July 15, 2015
• Last updated: July 16, 2015
• Start date: July 2015
• Est. completion date: August 2015

Study information

• Verified date: July 2015
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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
• 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).

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas de Pernambuco	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Daniella Cunha Brandao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes