Clinical trial NCT00510991: Non Invasive Ventilation in Acute Asthma
Official title: Non Invasive Ventilation in Acute Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Asthma
Keywords: ASTHMA
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2007-08-03
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Time to discharge
measure: Intensive care unit length of stay
timeFrame: Time to discharge
measure: Hospital length of stay
timeFrame: Time to discharge
Secondary outcomes:
measure: Improvement in the clinical status
timeFrame: Time to discharge
measure: Disappearance of pulsus paradoxus
timeFrame: Time to discharge
measure: Improvement in arterial blood gases
timeFrame: Time to discharge
measure: Improvement in oxygen saturation
timeFrame: Time to discharge
measure: Requirements of FiO2 , medications.
timeFrame: Time to discharge
measure: Need for mechanical ventilation
timeFrame: Time to discharge
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
Study officials:
affiliation: PGIMER, Chandigarh, India
name: Alok Nath, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.