Impact of Continuous Positive Airway Pressure on the Trea... | NCT01403467

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

NCT01403467

Sponsor

Ramathibodi Hospital

Status

Completed

Last Update Posted

Jul 27, 2011Estimated

Enrollment

86Actual

Phase

Phase 4

Conditions

Acute Asthma

Interventions

Continuous positive airway pressure

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MURA2009/1239	Other Identifier	Ramathibodi Hospital

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2011Actual

First Submitted Date

Jul 25, 2011

First Submission Date that Met QC Criteria

Jul 26, 2011

First Posted Date

Jul 27, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2011

Last Update Posted Date

Jul 27, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

86Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NIPPV	Experimental		Device: Continuous positive airway pressure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Continuous positive airway pressure	Device	CPAP 8 cmH2O	NIPPV	GoodKnight 420 G; Nellcor Puritan Bennett Inc.

Measure	Description	Time Frame
an improvement in PEFR, as % predicted		75 mins

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuda Sutherasan, M.D.	Ramathibodi Hospital, Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ramathibodi Hospital		Bangkok		10400	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D001982	Bronchial Diseases
D001249	Asthma

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D045422	Continuous Positive Airway Pressure

Ancestor Terms

ID	Term
D011175	Positive-Pressure Respiration
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided