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COPD AND ASSESSMENT OF RADIOLABELED AEROSOL DURING NONINVASIVE VENTILATION

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ClinicalTrials.gov Identifier: NCT02247856
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Collaborator:
Universidade Federal de Pernambuco
Information provided by (Responsible Party):
Daniella Cunha Brandao, Universidade Federal de Pernambuco

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.

Condition or disease Intervention/treatment Phase
COPD Other: Noninvasive ventilation Device: Jet Nebulizer Device: Vibrating Mesh Nebulizer (VMN) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IN VIVO ASSESSMENT OF RADIOLABELED AEROSOL DURING NONINVASIVE VENTILATION IN STABLE COPD: A RANDOMIZED CROSSOVER CLINICAL TRIAL
Study Start Date : January 2013
Actual Primary Completion Date : January 2013
Actual Study Completion Date : March 2013

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.




Primary Outcome Measures :
  1. radioaerosol deposition index into the lungs [ Time Frame: 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 :
  1. radioaerosol mass balance that reached pulmonary and extrapulmonary compartments. [ Time Frame: 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.




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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247856


Locations
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Brazil
Hospital das Clínicas de Pernambuco
Recife, Pernambuco, Brazil, 50670-901
Sponsors and Collaborators
Daniella Cunha Brandao
Universidade Federal de Pernambuco
Investigators
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Principal Investigator: Valdecir G Filho, PhD Universidade Federal de Pernambuco

Publications of Results:
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Responsible Party: Daniella Cunha Brandao, PhD, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02247856    
Other Study ID Numbers: Valdecir_COPD
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Keywords provided by Daniella Cunha Brandao, Universidade Federal de Pernambuco:
nebulizers,
noninvasive ventilation
COPD
scintigraphy,
aerosol