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Non Invasive Ventilation in Acute Asthma

Primary Purpose

Asthma

Status
Unknown status
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
nippv
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring ASTHMA

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PGIMERRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

NIPPV

Outcomes

Primary Outcome Measures

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
Intensive care unit length of stay
Hospital length of stay

Secondary Outcome Measures

Improvement in the clinical status
Disappearance of pulsus paradoxus
Improvement in arterial blood gases
Improvement in oxygen saturation
Requirements of FiO2 , medications.
Need for mechanical ventilation

Full Information

First Posted
August 2, 2007
Last Updated
February 26, 2008
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT00510991
Brief Title
Non Invasive Ventilation in Acute Asthma
Official Title
Non Invasive Ventilation in Acute Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
ASTHMA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
NIPPV
Intervention Type
Device
Intervention Name(s)
nippv
Primary Outcome Measure Information:
Title
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 Frame
Time to discharge
Title
Intensive care unit length of stay
Time Frame
Time to discharge
Title
Hospital length of stay
Time Frame
Time to discharge
Secondary Outcome Measure Information:
Title
Improvement in the clinical status
Time Frame
Time to discharge
Title
Disappearance of pulsus paradoxus
Time Frame
Time to discharge
Title
Improvement in arterial blood gases
Time Frame
Time to discharge
Title
Improvement in oxygen saturation
Time Frame
Time to discharge
Title
Requirements of FiO2 , medications.
Time Frame
Time to discharge
Title
Need for mechanical ventilation
Time Frame
Time to discharge

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Digamber Behera, MD
Phone
00911722756822
Email
dbehera@indiachest.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ritesh Agarwal, MD, DM
Phone
0091722756825
Email
riteshpgi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alok Nath, MD
Organizational Affiliation
PGIMER, Chandigarh, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
PGIMER
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Digamber Behera, MD
Phone
00911722756822
Email
dbehera@indiachest.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
20420722
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.
Results Reference
derived

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Non Invasive Ventilation in Acute Asthma

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