Asthma and Quantifying Delivery Of Radio Labeled Aerosol
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Noninvasive ventilation
Jet nebulizer
The vibrating mesh nebulizer (VMN)
Sponsored by

About this trial
This is an interventional treatment trial for Asthma focused on measuring vibrating mesh nebulizers, noninvasive ventilation, residual volume, pulmonary scintigraphy, radioaerosol, nebulization.
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
Sites / Locations
- Hospital das Clínicas de Pernambuco
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Experimental Group
Arm Description
Noninvasive ventilation + jet nebulizer
Noninvasive ventilation + vibrating mesh nebulizer
Outcomes
Primary Outcome Measures
To compare inhaled dose of radioaerosol into the lungs and determine distribution across horizontal and vertical gradients
Immediately after inhalation, participants sat in a chair with the back positioned in front to the gamma camera (STARCAM 3200 GE, California, USA) to obtain radioactives counts from the posterior thorax during a period of 500 seconds on a matrix of 256 X 256 matrix. After, participants were positioned sitting in front to the gama camera to obtain images from face. Then, the same procedure was performed to analysis deposition in the nebulizer, circuits, inspiratory filter, expiratory filter and face mask. Counts representing stomach were obtained from posterior thorax and corrections for decay of technetium were used to during extrapulmonary measurements.
Secondary Outcome Measures
To quantify mass balance of the delivery system and different compartments, including intrapulmonary and extrapulmonary deposition.
The analysis of deposition in pulmonary and extrapulmonary compartments was expressed as a percentage from the count in each compartment to the total radioaerosol mass generated by nebulizers. The inhaled radioaerosol was considered the sum of deposition into the upper airways, lungs and stomach.
Full Information
NCT ID
NCT01823926
First Posted
March 27, 2013
Last Updated
March 30, 2013
Sponsor
Universidade Federal de Pernambuco
1. Study Identification
Unique Protocol Identification Number
NCT01823926
Brief Title
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
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
vibrating mesh nebulizers, noninvasive ventilation, residual volume, pulmonary scintigraphy, radioaerosol, nebulization.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Noninvasive ventilation + jet nebulizer
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Noninvasive ventilation + vibrating mesh nebulizer
Intervention Type
Other
Intervention Name(s)
Noninvasive ventilation
Intervention Description
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
Device
Intervention Name(s)
Jet nebulizer
Intervention Description
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
Intervention Name(s)
The vibrating mesh nebulizer (VMN)
Intervention Description
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.
Primary Outcome Measure Information:
Title
To compare inhaled dose of radioaerosol into the lungs and determine distribution across horizontal and vertical gradients
Description
Immediately after inhalation, participants sat in a chair with the back positioned in front to the gamma camera (STARCAM 3200 GE, California, USA) to obtain radioactives counts from the posterior thorax during a period of 500 seconds on a matrix of 256 X 256 matrix. After, participants were positioned sitting in front to the gama camera to obtain images from face. Then, the same procedure was performed to analysis deposition in the nebulizer, circuits, inspiratory filter, expiratory filter and face mask. Counts representing stomach were obtained from posterior thorax and corrections for decay of technetium were used to during extrapulmonary measurements.
Time Frame
10 mouths
Secondary Outcome Measure Information:
Title
To quantify mass balance of the delivery system and different compartments, including intrapulmonary and extrapulmonary deposition.
Description
The analysis of deposition in pulmonary and extrapulmonary compartments was expressed as a percentage from the count in each compartment to the total radioaerosol mass generated by nebulizers. The inhaled radioaerosol was considered the sum of deposition into the upper airways, lungs and stomach.
Time Frame
10 mouths
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valdecir G Filho
Organizational Affiliation
Universidade Federal de Pernambuco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas de Pernambuco
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50670-901
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
19484669
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.
Results Reference
result
PubMed Identifier
22781558
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.
Results Reference
result
PubMed Identifier
12684289
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.
Results Reference
result
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Asthma and Quantifying Delivery Of Radio Labeled Aerosol
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