Asthma and Quantifying Delivery Of Radio Labeled Aerosol

Universidade Federal de Pernambuco

Status: Completed

Conditions: Asthma

Treatments: Device: Jet nebulizer; Device: The vibrating mesh nebulizer (VMN); Other: Noninvasive ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT01823926

valdecirtese2

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

13 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Noninvasive ventilation + jet nebulizer

Treatment:

Other: Noninvasive ventilation

Device: Jet nebulizer

Experimental Group

Experimental group

Description:

Noninvasive ventilation + vibrating mesh nebulizer

Treatment:

Device: The vibrating mesh nebulizer (VMN)

Other: Noninvasive ventilation