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Non Invasive Ventilation in Acute Asthma

Non Invasive Ventilation in Acute Asthma

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00510991
Enrollment
100
Registered
2007-08-03
Start date
2006-07-31
Completion date
2008-02-29
Last updated
2008-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

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.

Interventions

DEVICEnippv

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 valueTime to discharge
Intensive care unit length of stayTime to discharge
Hospital length of stayTime to discharge

Secondary

MeasureTime frame
Improvement in oxygen saturationTime to discharge
Improvement in the clinical statusTime to discharge
Need for mechanical ventilationTime to discharge
Requirements of FiO2 , medications.Time to discharge
Disappearance of pulsus paradoxusTime to discharge
Improvement in arterial blood gasesTime to discharge

Countries

India

Contacts

Primary ContactDigamber Behera, MD
dbehera@indiachest.org00911722756822
Backup ContactRitesh Agarwal, MD, DM
riteshpgi@gmail.com0091722756825

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026