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Radioaerossol Pulmonary Deposition Using Mesh in Normal Subjects

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ClinicalTrials.gov Identifier: NCT01889524
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : June 28, 2013
Sponsor:
Collaborators:
Georgia State University
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Daniella Cunha Brandao, Universidade Federal de Pernambuco

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
Normal Subjects Other: Mesh nebulizer Other: Jet nebulizer Other: Noninvasive ventilation-NIV Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : January 2012
Actual Primary Completion Date : January 2012
Actual Study Completion Date : April 2012

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.




Primary Outcome Measures :
  1. Radioaerosol deposition index [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

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): NCT01889524


Locations
Brazil
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