Radioaerossol Pulmonary Deposition Using Mesh in Normal Subjects

NCT01889524 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-06-28

No results posted yet for this study

Summary

In vivo deposition studies of aerosol administration during noninvasive ventilation are scarce in the current literature.

We assessed 10 normal subjects in a crossover study evaluated by pulmonary scintigraphy aiming to compare radiaoaerosol pulmonary index and radioaerosol mass balance in the different compartments (pulmonary and extrapulmonary) of radiotagged aerosol administered using vibrating mesh nebulizers (VMN) and conventional jet nebulizer (JN) during noninvasive ventilation (NIV).

Conditions

  • Normal Subjects

Interventions

OTHER

Mesh nebulizer

VMN (NIVO, Respironics®, Murrysville, Pennsylvania, USA) with an MMAD of 3.0 µm was placed in the elbow adapter at the mask. Inhalation was performed using diethilene triamine penta-acetic technetium (99mTc-DTPA) with radioactivity of 25 millicuries (Nobre et al., 2007). Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and normal saline solution to complete a fill volume of 3 mL.

OTHER

Jet nebulizer

The JN (Misty Max, Air Life, Yorba Linda, USA) with a particle MMAD of 5 µm (according to the manufacturer information) was positioned in the circuit using a "T" piece placed between the circuit leak and the mask, and operated with oxygen flow at 8 L/min. Inhalation was performed using diethilene triamine penta-acetic technetium (99mTc-DTPA) with radioactivity of 25 millicuries (Nobre et al., 2007). Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and normal saline solution to complete a fill volume of 3 mL.

OTHER

Noninvasive ventilation-NIV

Bilevel positive airway pressure (BiPAP Synchrony, Respironics®, Murrysville, Pennsylvania, USA) was applied through face mask (Comfort Full 2, Respironics®, Murrysville, Pennsylvania, USA) attached with straps and pressure adjusted to12 cmH2O peak inspiratory pressure and 5 cmH2O of expiratory pressure at the beginning of the procedure. Patients were adapted to use NIV before starting measurements, pressures were titrated before reaching the established levels and just after this period masks were fitted using the straps. They were oriented to use a breathing pattern inspiring deeply and exhaling slowing to avoid ventilator-patient asynchrony.

Sponsors & Collaborators

  • Georgia State University

    collaborator OTHER
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    collaborator OTHER_GOV
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV
  • Universidade Federal de Pernambuco

    lead OTHER

Principal Investigators

  • Valdecir C Galindo Filho, PhD · UFPE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-01-31
Completion
2012-04-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01889524 on ClinicalTrials.gov