Radioaerossol Pulmonary Deposition Using Mesh in Normal Subjects

NCT01889524 | Completed DMC

• 1 other identifier: valdecir tese normais
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Normal Subjects

Outcome Measures

Primary Outcomes (1)

• Radioaerosol deposition index

  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.

  4 m

Secondary Outcomes (1)

• Radioaerosol mass balance in pulmonary and extrapulmonary compartments

  4 m

Study Arms (2)

NIV plus jet

ACTIVE COMPARATOR

Noninvasive ventilation-NIV plus jet nebulizer

Other: Jet nebulizer; Other: Noninvasive ventilation-NIV

NIV plus Mesh

EXPERIMENTAL

Noninvasive ventilation- NIV plus Mesh nebulizer

Other: Mesh nebulizer; Other: Noninvasive ventilation-NIV

Interventions

Mesh nebulizer OTHER

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.

NIV plus Mesh

Jet nebulizer OTHER

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.

NIV plus jet

Noninvasive ventilation-NIV OTHER

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.

NIV plus Mesh; NIV plus jet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Hospital das Clínicas

Recife, Pernambuco, 50000-000, Brazil

Location

Related Publications (3)

• Newman SP, Pitcairn GR, Hirst PH, Rankin L. Radionuclide imaging technologies and their use in evaluating asthma drug deposition in the lungs. Adv Drug Deliv Rev. 2003 Jul 18;55(7):851-67. doi: 10.1016/s0169-409x(03)00081-4.

  PMID: 12842604 RESULT

• Nobre ME, Lopes F, Cordeiro L, Marinho PE, Silva TN, Amorim C, Cahalin LP, Dornelas de Andrade A. Inspiratory muscle endurance testing: pulmonary ventilation and electromyographic analysis. Respir Physiol Neurobiol. 2007 Jan 15;155(1):41-8. doi: 10.1016/j.resp.2006.04.005. Epub 2006 May 19.

  PMID: 16713403 RESULT

• Galindo-Filho VC, Ramos ME, Rattes CS, Barbosa AK, Brandao DC, Brandao SC, Fink JB, de Andrade AD. Radioaerosol Pulmonary Deposition Using Mesh and Jet Nebulizers During Noninvasive Ventilation in Healthy Subjects. Respir Care. 2015 Sep;60(9):1238-46. doi: 10.4187/respcare.03667. Epub 2015 Jun 23.

  PMID: 26106207 DERIVED

Study Officials

• Valdecir C Galindo Filho, PhD

  UFPE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: June 28, 2013
• Study Start: January 1, 2012
• Primary Completion: January 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 28, 2013

Record last verified: 2013-06

Locations

BR (1)