Radioaerossol Pulmonary Deposition Using Mesh in Normal Subjects

Normal Subjects Clinical Trial

Official title:

RADIOAEROSSOL PULMONARY DEPOSiTION USING MESH AND JET NEBULIZERS DURING NONINVASIVE VENTILATION IN NORMAL SUBJECTS: A RANDOMIZED CROSSOVER CLINICAL TRIAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01889524
• Other study ID #: valdecir tese normais
• Status: Completed
• Phase: N/A
• First received: June 25, 2013
• Last updated: June 27, 2013
• Start date: January 2012
• Est. completion date: April 2012

Study information

• Verified date: June 2013
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Normal Subjects

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas	Recife	Pernambuco

Sponsors (4)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Georgia State University

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. Review. — View Citation

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. Epub 2006 May — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Radioaerosol mass balance in pulmonary and extrapulmonary compartments	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.	4 m	Yes

External Links

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