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Non Invasive Ventilation in Acute Asthma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Postgraduate Institute of Medical Education and Research.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT00510991
First received: August 2, 2007
Last updated: February 26, 2008
Last verified: February 2008
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non Invasive Ventilation in Acute Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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
Experimental: A
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

No publications provided by Postgraduate Institute of Medical Education and Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

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

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 May 23, 2013