Non Invasive Ventilation in Acute Asthma

P

Postgraduate Institute of Medical Education and Research

Status and phase

Unknown
Phase 3

Conditions

Asthma

Treatments

Device: nippv

Study type

Interventional

Funder types

Other

Identifiers

NCT00510991
0002

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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) -

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

100 participants in 1 patient group

A
Experimental group
Description:
NIPPV
Treatment:
Device: nippv

Trial contacts and locations

0

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Central trial contact

Digamber Behera, MD; Ritesh Agarwal, MD, DM

Data sourced from clinicaltrials.gov

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