Non Invasive Ventilation in Acute Asthma

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

Study Overview

• Status: Unknown
• Conditions: Asthma
• Intervention / Treatment: Device: nippv

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Recruiting
    • PGIMER
    • Contact: Digamber Behera, MD; Phone Number: 00911722756822; Email: dbehera@indiachest.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; NIPPV	Device: nippv

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 value	Time to discharge
Intensive care unit length of stay	Time to discharge
Hospital length of stay	Time to discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Need for mechanical ventilation	Time to discharge

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Principal Investigator: Alok Nath, MD, PGIMER, Chandigarh, India

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Study Completion (Anticipated): February 1, 2008

Study Registration Dates

• First Submitted: August 2, 2007
• First Submitted That Met QC Criteria: August 2, 2007
• First Posted (Estimate): August 3, 2007

Study Record Updates

• Last Update Posted (Estimate): March 3, 2008
• Last Update Submitted That Met QC Criteria: February 26, 2008
• Last Verified: February 1, 2008

More Information

Terms related to this study

• Keywords: ASTHMA
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 0002