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Non Invasive Ventilation in Acute Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00510991
Recruitment Status : Unknown
Verified February 2008 by Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Recruiting
First Posted : August 3, 2007
Last Update Posted : March 3, 2008
Sponsor:
Information provided by:
Postgraduate Institute of Medical Education and Research

Tracking Information
First Submitted Date  ICMJE August 2, 2007
First Posted Date  ICMJE August 3, 2007
Last Update Posted Date March 3, 2008
Study Start Date  ICMJE July 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2007)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non Invasive Ventilation in Acute Asthma
Official Title  ICMJE Non Invasive Ventilation in Acute Asthma
Brief Summary 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE Device: nippv
Study Arms  ICMJE Experimental: A
NIPPV
Intervention: Device: nippv
Publications * Gupta D, Nath A, Agarwal R, Behera D. A prospective randomized controlled trial on the efficacy of noninvasive ventilation in severe acute asthma. Respir Care. 2010 May;55(5):536-43.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 2, 2007)		 100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00510991
Other Study ID Numbers  ICMJE 0002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Postgraduate Institute of Medical Education and Research
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alok Nath, MD PGIMER, Chandigarh, India
PRS Account Postgraduate Institute of Medical Education and Research
Verification Date February 2008

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