Clinical trial NCT02247856: COPD AND ASSESSMENT OF RADIOLABELED AEROSOL DURING NONINVASIVE VENTILATION
Official title: IN VIVO ASSESSMENT OF RADIOLABELED AEROSOL DURING NONINVASIVE VENTILATION IN STABLE COPD: A RANDOMIZED CROSSOVER CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: nebulizers,
noninvasive ventilation
COPD
scintigraphy,
aerosol
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
Collaborators: name: Universidade Federal de Pernambuco
First posted: 2014-09-25
Enrollment: 9
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: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: radioaerosol deposition index into the lungs
timeFrame: 10 months
Secondary outcomes:
measure: radioaerosol mass balance that reached pulmonary and extrapulmonary compartments.
timeFrame: 10 months
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, PhD
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.