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Non Invasive Ventilation in Acute Asthma

This study is currently recruiting participants.
Verified by Postgraduate Institute of Medical Education and Research, February 2008

Sponsored by: Postgraduate Institute of Medical Education and Research
Information provided by: Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT00510991
  Purpose

The aim of this study is to compare the efficacy of noninvasive positive pressure ventilation versus best medical therapy in patients with acute severe asthma


Condition Intervention Phase
Asthma
Device: nippv
Phase III

MedlinePlus related topics:   Asthma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:   Non Invasive Ventilation in Acute Asthma

Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Improvement in lung function defined as an increase of at least 50% in FEV1 as compared to baseline value on admission or an increase in FEV1 to > 60% of predicted value [ Time Frame: Time to discharge ]
  • Intensive care unit length of stay [ Time Frame: Time to discharge ]
  • Hospital length of stay [ Time Frame: Time to discharge ]

Secondary Outcome Measures:
  • Improvement in the clinical status [ Time Frame: Time to discharge ]
  • Disappearance of pulsus paradoxus [ Time Frame: Time to discharge ]
  • Improvement in arterial blood gases [ Time Frame: Time to discharge ]
  • Improvement in oxygen saturation [ Time Frame: Time to discharge ]
  • Requirements of FiO2 , medications. [ Time Frame: Time to discharge ]
  • Need for mechanical ventilation [ Time Frame: Time to discharge ]

Estimated Enrollment:   100
Study Start Date:   July 2006
Estimated Study Completion Date:   February 2008

Arms Assigned Interventions
A: Experimental
NIPPV
Device: nippv

Detailed Description:

In the past, the mainstay of treatment for patients progressing to respiratory failure from acute asthma was intubation and mechanical ventilation. Newer strategies to prevent these intubations to prevent the inherent complications are being explored in form of various pharmacological means like heliox, magnesium sulfate etc. Non pharmacological strategies among which non invasive positive pressure ventilation (NIPPV) is one of the most challenging after showing success in patients with chronic obstructive airway disease (COPD) and cardiogenic pulmonary edema.

Data on efficacy of NIPPV in the management of AA is sparse but has the potential to improve the management of acute severe asthma. Noninvasive ventilation merits further studies in patients with AA, and some consensus panels have suggested that its widespread application in patients with asthma await such trials.The role of NIPPV is not yet clear and needs further studies and keeping this in view we planned this study to study the role of NIPPV in the management of acute asthma.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. History of asthma of at least 1 year
  2. FEV1 < 50% of predicted (by age, height, and gender) or FEV1 < 200 L/minute
  3. Respiratory rate > 30 breaths/min
  4. All patients judged by the attending physician as having an acute attack of asthma ( Inability to speak in sentences in one breath, SaO2 < 92% ,pulsus paradoxus > 10 mm of Hg) -

Exclusion Criteria:

  1. Smoking history of > 10 years
  2. Chronic obstructive pulmonary disease
  3. Endotracheal intubation
  4. Room air saturation < 88 % or arterial PaO2 < 55 mm of Hg
  5. Hemodynamic instability defined as systolic BP < 90 mm Hg
  6. Altered state of consciousness
  7. Congestive heart failure
  8. Ischemic heart disease
  9. Upper airway obstruction
  10. Facial deformity
  11. Pregnancy
  12. Pulmonary infiltrates consistent with pulmonary edema or pneumonia
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00510991

Contacts
Contact: Digamber Behera, MD     00911722756822     dbehera@indiachest.org    
Contact: Ritesh Agarwal, MD, DM     0091722756825     riteshpgi@gmail.com    

Locations
India
PGIMER     Recruiting
      Chandigarh, India, 160012
      Contact: Digamber Behera, MD     00911722756822     dbehera@indiachest.org    

Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research

Investigators
Principal Investigator:     Alok Nath, MD     PGIMER, Chandigarh, India    
  More Information


Study ID Numbers:   0002
First Received:   August 2, 2007
Last Updated:   February 26, 2008
ClinicalTrials.gov Identifier:   NCT00510991
Health Authority:   India: Institutional Review Board

Keywords provided by Postgraduate Institute of Medical Education and Research:
ASTHMA  

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on October 17, 2008




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