Clinical trial NCT01823926: Asthma and Quantifying Delivery Of Radio Labeled Aerosol
Official title: Quantifying Delivery Of Radio Labeled Aerosol During Noninvasive Ventilation To Stable Moderate And Severe Asthmatics: A Randomized, Cross-Over Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: vibrating mesh nebulizers
noninvasive ventilation
residual volume
pulmonary scintigraphy
radioaerosol
nebulization.
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: To compare inhaled dose of radioaerosol into the lungs and determine distribution across horizontal and vertical gradients
timeFrame: 10 mouths
Secondary outcomes:
measure: To quantify mass balance of the delivery system and different compartments, including intrapulmonary and extrapulmonary deposition.
timeFrame: 10 mouths
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Hospital das Clínicas de Pernambuco
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Valdecir G Filho
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brandao DC, Lima VM, Filho VG, Silva TS, Campos TF, Dean E, de Andrade AD. Reversal of bronchial obstruction with bi-level positive airway pressure and nebulization in patients with acute asthma. J Asthma. 2009 May;46(4):356-61. doi: 10.1080/02770900902718829.
citation: Galindo-Filho VC, Brandao DC, Ferreira Rde C, Menezes MJ, Almeida-Filho P, Parreira VF, Silva TN, Rodrigues-Machado Mda G, Dean E, Dornelas de Andrade A. Noninvasive ventilation coupled with nebulization during asthma crises: a randomized controlled trial. Respir Care. 2013 Feb;58(2):241-9. doi: 10.4187/respcare.01371.
citation: Soroksky A, Stav D, Shpirer I. A pilot prospective, randomized, placebo-controlled trial of bilevel positive airway pressure in acute asthmatic attack. Chest. 2003 Apr;123(4):1018-25. doi: 10.1378/chest.123.4.1018.