COPD AND ASSESSMENT OF RADIOLABELED AEROSOL DURING NONINVASIVE VENTILATION

IN VIVO ASSESSMENT OF RADIOLABELED AEROSOL DURING NONINVASIVE VENTILATION IN STABLE COPD: A RANDOMIZED CROSSOVER CLINICAL TRIAL

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: Noninvasive ventilation; Device: Jet Nebulizer; Device: Vibrating Mesh Nebulizer (VMN)

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50670-901
      • Hospital das Clínicas de Pernambuco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control Group; Noninvasive ventilation+ jet nebulizer	Other: 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 after a period of adaptation before beginning the procedure to avoid ventilator-patient asynchrony; Device: 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
EXPERIMENTAL: Experimental Group; Noninvasive ventilation+ Vibrating Mesh Nebulizer (VMN)	Other: 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 after a period of adaptation before beginning the procedure to avoid ventilator-patient asynchrony; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radioaerosol deposition index into the lungs	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	10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radioaerosol mass balance that reached pulmonary and extrapulmonary compartments.	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.	10 months

Collaborators and Investigators

• Sponsor: Daniella Cunha Brandao
• Collaborators: Universidade Federal de Pernambuco
• Investigators: Principal Investigator: Valdecir G Filho, PhD, Universidade Federal de Pernambuco

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: September 21, 2014
• First Submitted That Met QC Criteria: September 23, 2014
• First Posted (ESTIMATE): September 25, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): September 25, 2014
• Last Update Submitted That Met QC Criteria: September 23, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: COPD; noninvasive ventilation; aerosol; nebulizers,; scintigraphy,
• Other Study ID Numbers: Valdecir_COPD