Asthma and Quantifying Delivery Of Radio Labeled Aerosol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-08-31

Brief Summary

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Introduction: Inhalation therapy has been established as an efficient route to treat asthma exacerbations, but coupled to noninvasive ventilation (NIV) remains quite challenging.

Objectives: The aim of this study were to compare radiaoaerosol pulmonary index and radioaerosol mass balance in the different compartments (pulmonary and extrapulmonary) using vibrating mesh nebulizers (VMN) and jet nebulizer (JN) coupled to noninvasive ventilation (NIV).

Material and methods: The investigators assessed 10 stable moderate to severe asthmatics in a crossover study. Patients was randomly assigned to participate in both phases of the study: Phase 1(NIV+MN) and phase 2(NIV+JN). DTPA-Tc99m with radioactivity of 25 miC was used to inhaler using JN positioned in the circuit using a "T" piece, particle size generation in a five micron range and oxygen flow tritated at eight L/min and MN was positioned in the mask, particle size generation in a one range and connected to electrical energy. NIV was used a bilevel pressure through a face mask attached with straps and pressure adjusted were 12 cmH2O and 5 cmH2O as inspiratory and expiratory pressures, respectively. After, radioactivity counts were performed using a gama camera and regions of interest were delimited. To calculate aerosol mass balance the investigators considered the amount of radioaerosol deposited into the lungs, upper airways, stomach, nebulizer, circuit, inspiratory and expiratory filters, and mask divided for each of these compartments and represented as a percentage.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control Group

Noninvasive ventilation + jet nebulizer

Group Type ACTIVE_COMPARATOR

Noninvasive ventilation

Intervention Type OTHER

Bilevel positive 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 were 12 cmH2O of inspiratory pressure and 5 cmH2O of expiratory pressure at the beginning of the procedure (França et al., 2006).

Jet nebulizer

Intervention Type DEVICE

Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and 3 mL of saline solution was added to complete 3 Ml. JN (Mist yMax, Air Life, Yorba Linda, USA) was positioned in the circuit using a "T" piece, particle size generation in a 5 µm range (according to the manufacturer information) and flow oxygen tritated at 8 L/min.

Experimental Group

Noninvasive ventilation + vibrating mesh nebulizer

Group Type EXPERIMENTAL

Noninvasive ventilation

Intervention Type OTHER

Bilevel positive 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 were 12 cmH2O of inspiratory pressure and 5 cmH2O of expiratory pressure at the beginning of the procedure (França et al., 2006).

The vibrating mesh nebulizer (VMN)

Intervention Type DEVICE

Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and 3 mL of saline solution was added to complete 3 Ml. VMN (Aeroneb Solo, Galway, Ireland) was positioned in the mask using an elbow (Elbow Kit, Respironics®, Murrysville, Pennsylvania, USA), particle size generation in a 1 µm and connected to electrical energy.

Interventions

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Noninvasive ventilation

Bilevel positive 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 were 12 cmH2O of inspiratory pressure and 5 cmH2O of expiratory pressure at the beginning of the procedure (França et al., 2006).

Intervention Type OTHER

Jet nebulizer

Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and 3 mL of saline solution was added to complete 3 Ml. JN (Mist yMax, Air Life, Yorba Linda, USA) was positioned in the circuit using a "T" piece, particle size generation in a 5 µm range (according to the manufacturer information) and flow oxygen tritated at 8 L/min.

Intervention Type DEVICE

The vibrating mesh nebulizer (VMN)

Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and 3 mL of saline solution was added to complete 3 Ml. VMN (Aeroneb Solo, Galway, Ireland) was positioned in the mask using an elbow (Elbow Kit, Respironics®, Murrysville, Pennsylvania, USA), particle size generation in a 1 µm and connected to electrical energy.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* stable moderate to severe asthma (FEV1 \> 60% and \> 80% and PEF with a variation of 30% from the predicted values to moderate and FVE1 \> 60% and );
* More than one year elapsed since the diagnosis of asthma;
* None exacerbation in the last six months;
* Age between 18 - 60 years, from both sexes,
* Able to understand verbal commands
* Consent to participate in this protocol.

Exclusion Criteria

* presence of dyspnea;
* smoking history;
* cardiopulmonary diseases (chronic obstructive pulmonary disease, pneumonia, cardiac failure, myocardial infarction, pneumothorax);
* hyperthermia;
* hemodynamic instability (heart rate \> 150 bpm and systolic blood pressure \< 90 mmHg);
* arrhythmia absence;
* pregnancy
* contraindications for use of noninvasive ventilation

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No