Radioaerossol Pulmonary Deposition Using Mesh in Normal Subjects

Not Applicable

Completed

• Conditions: Normal Subjects
• Interventions: Other: Jet nebulizer; Other: Mesh nebulizer; Other: Noninvasive ventilation-NIV

• Registration Number: NCT01889524
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-01
• Study Completion: 2012-04
• Status Verified: 2013-06
• Study First Submitted: 2013-06-25
• Study First Submitted QC: 2013-06-27
• Last Update Submitted: 2013-06-27
• Study First Posted: 2013-06-28
• Last Update Posted: 2013-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NIV plus jet	Jet nebulizer	Noninvasive ventilation-NIV plus jet nebulizer
NIV plus jet	Noninvasive ventilation-NIV	Noninvasive ventilation-NIV plus jet nebulizer
NIV plus Mesh	Mesh nebulizer	Noninvasive ventilation- NIV plus Mesh nebulizer
NIV plus Mesh	Noninvasive ventilation-NIV	Noninvasive ventilation- NIV plus Mesh nebulizer

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Hospital das Clínicas; 🇧🇷 Recife, Pernambuco, Brazil