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Impact of Continuous Positive Airway Pressure on the Treatment of Acute Asthma Exacerbation

Primary Purpose

Acute Asthma

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Continuous positive airway pressure
Sponsored by
Ramathibodi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Asthma focused on measuring Bronchial disease, asthma, continuous positive airway pressure (CPAP), Bronchoconstriction

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aged over 18 years
  • known asthmatic patients visiting ED with acute exacerbation
  • had given their written informed consent.

Exclusion Criteria:

  • smoking history
  • chronic obstructive pulmonary disease
  • required intubation
  • instability of hemodynamic or arrhythmia
  • unable to perform PEFR
  • facial abnormality
  • pulmonary infiltration
  • pregnancy.

Sites / Locations

  • Ramathibodi Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NIPPV

Arm Description

Outcomes

Primary Outcome Measures

an improvement in PEFR, as % predicted

Secondary Outcome Measures

Full Information

First Posted
July 25, 2011
Last Updated
July 26, 2011
Sponsor
Ramathibodi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01403467
Brief Title
Impact of Continuous Positive Airway Pressure on the Treatment of Acute Asthma Exacerbation
Official Title
Impact of Continuous Positive Airway Pressure on the Treatment of Acute Asthma Exacerbation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ramathibodi Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This current study aimed to demonstrate the effectiveness of the addition of CPAP to the current conventional therapy in terms of airway obstruction improvement in acute asthma patients.
Detailed Description
Continuous positive airway pressure (CPAP) is widely used in providing ventilator support. However, its role in an acute asthmatic attack is uncertain. The purpose of this study was to compare the efficacy of CPAP when used in addition to conventional therapy with conventional therapy alone in the management of acute asthma exacerbation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Asthma
Keywords
Bronchial disease, asthma, continuous positive airway pressure (CPAP), Bronchoconstriction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NIPPV
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure
Other Intervention Name(s)
GoodKnight 420 G; Nellcor Puritan Bennett Inc.
Intervention Description
CPAP 8 cmH2O
Primary Outcome Measure Information:
Title
an improvement in PEFR, as % predicted
Time Frame
75 mins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged over 18 years known asthmatic patients visiting ED with acute exacerbation had given their written informed consent. Exclusion Criteria: smoking history chronic obstructive pulmonary disease required intubation instability of hemodynamic or arrhythmia unable to perform PEFR facial abnormality pulmonary infiltration pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuda Sutherasan, M.D.
Organizational Affiliation
Ramathibodi Hospital, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

Impact of Continuous Positive Airway Pressure on the Treatment of Acute Asthma Exacerbation

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