COPD AND ASSESSMENT OF RADIOLABELED AEROSOL DURING NONINVASIVE VENTILATION

Not Applicable

Completed

• Conditions: COPD
• Interventions: Other: Noninvasive ventilation; Device: Jet Nebulizer; Device: Vibrating Mesh Nebulizer (VMN)

• Registration Number: NCT02247856
• Lead Sponsor: Daniella Cunha Brandao

Brief Summary

Background: Beneficial effects from noninvasive ventilation (NIV) in acute COPD are well-established, but couple to nebulization is still challenging. Aim: To compare radioaerosol pulmonary deposition and radioaerosol mass balance in the different compartments (pulmonary and extrapulmonary) using vibrating mesh nebulizer (VMN) and jet nebulizer (JN) coupled to NIV.Methods: It was a crossover study involving 9 stable moderate to severe COPD randomly allocated for both phases of the study: Phase 1(NIV+MN,n=9) and phase 2(NIV+JN,n=9). Bronchodilators were delivered during NIV using a facemask (pressures of 12 cmH2O and 5 cmH2O - inspiratory and expiratory, respectively). Radioactivity counts were performed using a gamma camera and regions of interest(ROIs) were delimited. We determine aerosol mass balance from the lungs, upper airways, stomach, nebulizer, circuit, inspiratory and expiratory filters, and mask as a percentage.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-03
• Status Verified: 2014-09
• Study First Submitted: 2014-09-21
• Study First Submitted QC: 2014-09-23
• Last Update Submitted: 2014-09-23
• Study First Posted: 2014-09-25
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Inclusion criteria were considered as follows: moderate to severe stable COPD (50% ≤ FEV1 < 80% from predicted values or 30% ≤ FEV1 < 50% from predicted values)(4); none exacerbation in the last six months; age between 18 - 60 years; both sexes; no smoking history; able to understand verbal commands, and consent to participate in this protocol.

Exclusion Criteria

Presence of dyspnea; 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; and contraindications for use of NIV (29).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control Group	Jet Nebulizer	Noninvasive ventilation+ jet nebulizer
Experimental Group	Noninvasive ventilation	Noninvasive ventilation+ Vibrating Mesh Nebulizer (VMN)
Control Group	Noninvasive ventilation	Noninvasive ventilation+ jet nebulizer
Experimental Group	Vibrating Mesh Nebulizer (VMN)	Noninvasive ventilation+ Vibrating Mesh Nebulizer (VMN)

Primary Outcome Measures

Name	Time	Method
radioaerosol deposition index into the lungs	10 months	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 radioactivity counts from the posterior thorax during a period of 300 seconds on a matrix of 256 X 256. 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

Name	Time	Method
radioaerosol mass balance that reached pulmonary and extrapulmonary compartments.	10 months	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.; Regions of interest were delimited based on a previous protocol and RDI was expressed as absolute values and was calculated according to the counts generated from each regions of interest.

Trial Locations

Locations (1)

Hospital das Clínicas de Pernambuco; 🇧🇷 Recife, Pernambuco, Brazil