Radioaerossol Pulmonary Deposition Using Mesh in Normal Subjects

Universidade Federal de Pernambuco

Status: Completed

Conditions: Normal Subjects

Treatments: Other: Noninvasive ventilation-NIV; Other: Jet nebulizer; Other: Mesh nebulizer

Study type: Interventional

Funder types: Other

Identifiers

NCT01889524

valdecir tese normais

Details and patient eligibility

About

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).

Enrollment: 10 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

NIV plus jet

Active Comparator group

Description:

Noninvasive ventilation-NIV plus jet nebulizer

Treatment:

Other: Jet nebulizer

Other: Noninvasive ventilation-NIV

NIV plus Mesh

Experimental group

Description:

Noninvasive ventilation- NIV plus Mesh nebulizer

Treatment:

Other: Mesh nebulizer

Other: Noninvasive ventilation-NIV