Radioaerossol Pulmonary Deposition Using Mesh in Normal Subjects

Sponsor
Universidade Federal de Pernambuco (Other)
Overall Status
Completed
CT.gov ID
NCT01889524
Collaborator
Georgia State University (Other), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. (Other), Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other)
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Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Other: Mesh nebulizer
  • Other: Jet nebulizer
  • Other: Noninvasive ventilation-NIV
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
RADIOAEROSSOL PULMONARY DEPOSiTION USING MESH AND JET NEBULIZERS DURING NONINVASIVE VENTILATION IN NORMAL SUBJECTS: A RANDOMIZED CROSSOVER CLINICAL TRIAL
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Apr 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: NIV plus jet

Noninvasive ventilation-NIV plus jet nebulizer

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.

Experimental: NIV plus Mesh

Noninvasive ventilation- NIV plus Mesh nebulizer

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: 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.

Outcome Measures

Primary Outcome Measures

  1. Radioaerosol deposition index [4 m]

    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. 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. VMN (NIVO, Respironics®, Murrysville, Pennsylvania, USA) with an MMAD of 3.0 µm was placed in the elbow adapter at the mask.

Secondary Outcome Measures

  1. Radioaerosol mass balance in pulmonary and extrapulmonary compartments [4 m]

    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 during extrapulmonary measurements. The analysis of deposition in pulmonary and extrapulmonary compartments was expressed as a percentage from the cumulative count in each compartment representing the total radioaerosol mass.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • No history of lung disease;

  • Forced vital capacity (FVC) or forced expiratory volume in the first second (FEV1) higher or equal to 80% from predicted values (Pereira et al., 1992),

  • No history of smoking;

  • Without respiratory or cardiovascular disease;

  • Ability to understand verbal commands;

  • Willing to provide signed consent to participate in this study.

Exclusion Criteria:
  • Pregnant;

  • Were unable to tolerate NIV (Metha and Hill, 2001).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital das Clínicas Recife Pernambuco Brazil 50000-000

Sponsors and Collaborators

  • Universidade Federal de Pernambuco
  • Georgia State University
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Valdecir C Galindo Filho, PhD, UFPE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daniella Cunha Brandao, PhD, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier:
NCT01889524
Other Study ID Numbers:
  • valdecir tese normais
First Posted:
Jun 28, 2013
Last Update Posted:
Jun 28, 2013
Last Verified:
Jun 1, 2013

Study Results

No Results Posted as of Jun 28, 2013