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

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ClinicalTrials.gov Identifier: NCT01012050
Recruitment Status : Completed
First Posted : November 11, 2009
Last Update Posted : November 11, 2009
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
Universidade Federal de Pernambuco

April 22, 2009
November 11, 2009
November 11, 2009
June 2007
January 2008   (Final data collection date for primary outcome measure)
Cardiopulmonary characteristics [ Time Frame: 6 months ]
Same as current
No Changes Posted
Radioaerosol pulmonary index, radioaerosol penetration index and pulmonary clearance. [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
Radioaerosol Pulmonary Deposition During Asthma Exacerbation Through Noninvasive Ventilation
Analysing the Effects of Coupling Nebulization to Noninvasive Ventilation Through Pulmonary Scintigraphy on the Radioaerosol Deposition During Asthma Exacerbation
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Asthma
  • Device: NV
    Noninvasive ventilation coupled with nebulization(Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm)
    Other Name: Interventional Group
  • Other: NEB group
    Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm
    Other Name: Control group
  • Experimental: NV Group
    Performed nebulization coupled with noninvasive ventilation
    Intervention: Device: NV
  • Active Comparator: NEB group
    Performed nebulization alone.
    Intervention: Other: NEB group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
Same as current
January 2008
January 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01012050
VNI1972NEB
Yes
Not Provided
Not Provided
Valdecir Castor Galindo Filho, Universidade Federal de Pernambuco
Universidade Federal de Pernambuco
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Principal Investigator: Valdecir C Galindo Universidade Federal de Pernambuco
Universidade Federal de Pernambuco
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP