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

This study has been completed.
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier:
NCT01012050
First received: April 22, 2009
Last updated: November 10, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention
Asthma
Device: NV
Other: NEB group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Analysing the Effects of Coupling Nebulization to Noninvasive Ventilation Through Pulmonary Scintigraphy on the Radioaerosol Deposition During Asthma Exacerbation

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Pernambuco:

Primary Outcome Measures:
  • Cardiopulmonary characteristics [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Radioaerosol pulmonary index, radioaerosol penetration index and pulmonary clearance. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 39
Study Start Date: June 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NV Group
Performed nebulization coupled with noninvasive ventilation
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
Active Comparator: NEB group
Performed nebulization alone.
Other: NEB group
Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm
Other Name: Control group

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01012050

Locations
Brazil
Valdecir Castor Galindo Filho
Recife, Pernambuco, Brazil
Sponsors and Collaborators
Universidade Federal de Pernambuco
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Principal Investigator: Valdecir C Galindo Universidade Federal de Pernambuco
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Valdecir Castor Galindo Filho, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT01012050     History of Changes
Other Study ID Numbers: VNI1972NEB
Study First Received: April 22, 2009
Last Updated: November 10, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Federal de Pernambuco:
Asthma
status asthmatics

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2014