Non Invasive Ventilation in Acute Asthma
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 asthma
Started Jul 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 2, 2007
CompletedFirst Posted
Study publicly available on registry
August 3, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedMarch 3, 2008
February 1, 2008
August 2, 2007
February 26, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 to discharge
Intensive care unit length of stay
Time to discharge
Hospital length of stay
Time to discharge
Secondary Outcomes (6)
Improvement in the clinical status
Time to discharge
Disappearance of pulsus paradoxus
Time to discharge
Improvement in arterial blood gases
Time to discharge
Improvement in oxygen saturation
Time to discharge
Requirements of FiO2 , medications.
Time to discharge
- +1 more secondary outcomes
Study Arms (1)
A
EXPERIMENTALNIPPV
Interventions
Eligibility Criteria
You may qualify if:
- History of asthma of at least 1 year
- FEV1 \< 50% of predicted (by age, height, and gender) or FEV1 \< 200 L/minute
- Respiratory rate \> 30 breaths/min
- 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) -
You may not qualify if:
- Smoking history of \> 10 years
- Chronic obstructive pulmonary disease
- Endotracheal intubation
- Room air saturation \< 88 % or arterial PaO2 \< 55 mm of Hg
- Hemodynamic instability defined as systolic BP \< 90 mm Hg
- Altered state of consciousness
- Congestive heart failure
- Ischemic heart disease
- Upper airway obstruction
- Facial deformity
- Pregnancy
- Pulmonary infiltrates consistent with pulmonary edema or pneumonia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PGIMER
Chandigarh, Chandigarh, 160012, India
Related Publications (1)
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.
PMID: 20420722DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alok Nath, MD
PGIMER, Chandigarh, India
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 2, 2007
First Posted
August 3, 2007
Study Start
July 1, 2006
Study Completion
February 1, 2008
Last Updated
March 3, 2008
Record last verified: 2008-02