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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Asthma Device: nippv Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non Invasive Ventilation in Acute Asthma
Study Start Date : July 2006
Estimated Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: A
NIPPV
 Device: nippv


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Intensive care unit length of stay [ Time Frame: Time to discharge ]
  3. Hospital length of stay [ Time Frame: Time to discharge ]

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

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00510991


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

Locations
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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
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Principal Investigator: Alok Nath, MD PGIMER, Chandigarh, India
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00510991    
Other Study ID Numbers: 0002
First Posted: August 3, 2007    Key Record Dates
Last Update Posted: March 3, 2008
Last Verified: February 2008
Keywords provided by Postgraduate Institute of Medical Education and Research:
ASTHMA
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases