Non Invasive Ventilation in Acute Asthma

NCT ID: NCT00510991

Last Updated: 2008-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-02-29

Brief Summary

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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

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

NIPPV

Group Type EXPERIMENTAL

nippv

Intervention Type DEVICE

Interventions

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nippv

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Principal Investigators

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Alok Nath, MD

Role: PRINCIPAL_INVESTIGATOR

PGIMER, Chandigarh, India

Locations

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PGIMER

Chandigarh, Chandigarh, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Digamber Behera, MD

Role: CONTACT

00911722756822

Ritesh Agarwal, MD, DM

Role: CONTACT

0091722756825

Facility Contacts

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Digamber Behera, MD

Role: primary

00911722756822

References

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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.

Reference Type DERIVED
PMID: 20420722 (View on PubMed)

Other Identifiers

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0002

Identifier Type: -

Identifier Source: org_study_id

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