Radioaerossol Pulmonary Deposition Using Mesh in Normal Subjects

U

Universidade Federal de Pernambuco

Status

Completed

Conditions

Normal Subjects

Treatments

Other: Mesh nebulizer
Other: Noninvasive ventilation-NIV
Other: Jet 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)

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: Noninvasive ventilation-NIV
Other: Mesh nebulizer

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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