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Radioaerosol Pulmonary Deposition During Asthma Exacerbation Through Noninvasive Ventilation (NV)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
NV
NEB group
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, status asthmatics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of moderate to severe asthma (FEV1 < 60 % of predicted values)
  • Breathing rate > 25 bpm
  • History of asthma for at least 1 year
  • Duration of current asthma attack of < 7 days
  • Reversibility of FEV1 of at least ≤ 10% after the administration of bronchodilator drugs

Exclusion Criteria:

  • Current smoker
  • Presence of cardiopulmonary disease (COPD, pneumonia, heart failure, myocardial infarction, pneumothorax)
  • Hyperthermia
  • Indication of intubation and invasive mechanical ventilation;
  • Hemodynamic instability (heart rate > 150 bpm and systolic blood pressure < 90 mmHg)
  • Cardiac arrhythmia
  • Changes in consciousness
  • Pregnancy
  • Contraindications to use NV

Sites / Locations

  • Valdecir Castor Galindo Filho

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NV Group

NEB group

Arm Description

Performed nebulization coupled with noninvasive ventilation

Performed nebulization alone.

Outcomes

Primary Outcome Measures

Cardiopulmonary characteristics

Secondary Outcome Measures

Radioaerosol pulmonary index, radioaerosol penetration index and pulmonary clearance.

Full Information

First Posted
April 22, 2009
Last Updated
November 10, 2009
Sponsor
Universidade Federal de Pernambuco
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT01012050
Brief Title
Radioaerosol Pulmonary Deposition During Asthma Exacerbation Through Noninvasive Ventilation
Acronym
NV
Official Title
Analysing the Effects of Coupling Nebulization to Noninvasive Ventilation Through Pulmonary Scintigraphy on the Radioaerosol Deposition During Asthma Exacerbation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universidade Federal de Pernambuco
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Despite the physiologic and clinical effects provided by coupling nebulization with noninvasive ventilation in asthma exacerbation, there are few and controversial studies reported in the literature.
Detailed Description
Reduced work of breathing, increased oxygenation and increased in expiratory peak flow (EPF) and forced expiratory volume in the first second (FEV1) are benefits of noninvasive ventilation (NV) in the treatment of asthma. Despite these clinical improvements attributed to NV during asthma exacerbations and the well-established effects of nebulization, there are few studies in the literature coupling both therapeutic resources. In addition to this, no studies on scintigraphic analysis of radioaerosol deposition coupled with NV in asthmatics have published. A previous study was published by our group, but involved healthy subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, status asthmatics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NV Group
Arm Type
Experimental
Arm Description
Performed nebulization coupled with noninvasive ventilation
Arm Title
NEB group
Arm Type
Active Comparator
Arm Description
Performed nebulization alone.
Intervention Type
Device
Intervention Name(s)
NV
Other Intervention Name(s)
Interventional Group
Intervention Description
Noninvasive ventilation coupled with nebulization(Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm)
Intervention Type
Other
Intervention Name(s)
NEB group
Other Intervention Name(s)
Control group
Intervention Description
Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm
Primary Outcome Measure Information:
Title
Cardiopulmonary characteristics
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Radioaerosol pulmonary index, radioaerosol penetration index and pulmonary clearance.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of moderate to severe asthma (FEV1 < 60 % of predicted values) Breathing rate > 25 bpm History of asthma for at least 1 year Duration of current asthma attack of < 7 days Reversibility of FEV1 of at least ≤ 10% after the administration of bronchodilator drugs Exclusion Criteria: Current smoker Presence of cardiopulmonary disease (COPD, pneumonia, heart failure, myocardial infarction, pneumothorax) Hyperthermia Indication of intubation and invasive mechanical ventilation; Hemodynamic instability (heart rate > 150 bpm and systolic blood pressure < 90 mmHg) Cardiac arrhythmia Changes in consciousness Pregnancy Contraindications to use NV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valdecir C Galindo
Organizational Affiliation
Universidade Federal de Pernambuco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Valdecir Castor Galindo Filho
City
Recife
State/Province
Pernambuco
Country
Brazil

12. IPD Sharing Statement

Citations:
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
background
PubMed Identifier
16139491
Citation
Franca EE, Dornelas de Andrade AF, Cabral G, Almeida Filho P, Silva KC, Galindo Filho VC, Marinho PE, Lemos A, Parreira VF. Nebulization associated with bi-level noninvasive ventilation: analysis of pulmonary radioaerosol deposition. Respir Med. 2006 Apr;100(4):721-8. doi: 10.1016/j.rmed.2005.07.012. Epub 2005 Aug 31.
Results Reference
background
PubMed Identifier
18344635
Citation
Soma T, Hino M, Kida K, Kudoh S. A prospective and randomized study for improvement of acute asthma by non-invasive positive pressure ventilation (NPPV). Intern Med. 2008;47(6):493-501. doi: 10.2169/internalmedicine.47.0429. Epub 2008 Mar 17.
Results Reference
background
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
derived
Links:
URL
http://www.nlm.nih.gov/medlineplus/asthma.html
Description
Related Info
URL
http://www.asthma.org.uk/
Description
Related Info

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Radioaerosol Pulmonary Deposition During Asthma Exacerbation Through Noninvasive Ventilation

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