RADIOAEROSSOL PULMONARY DEPOSiTION USING MESH AND JET NEBULIZERS DURING NONINVASIVE VENTILATION IN NORMAL SUBJECTS: A RANDOMIZED CROSSOVER CLINICAL TRIAL
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Radioaerosol deposition index
Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
Outcomes
Primary Outcomes
Radioaerosol deposition index
Time Frame: 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 Outcomes
- Radioaerosol mass balance in pulmonary and extrapulmonary compartments(4 m)
Investigators
Daniella Cunha Brandao
PhD
Universidade Federal de Pernambuco