Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001267842
Ethics application status
Approved
Date submitted
1/11/2012
Date registered
4/12/2012
Date last updated
4/12/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Agreement between arterial and venous pH and partial pressure of carbon dioxide (pCO2) in patients undergoing non-invasive ventilation in the emergency department
Scientific title
Agreement between arterial and venous pH and partial pressure of carbon dioxide (pCO2) in patients undergoing non-invasive ventilation in the emergency department
Secondary ID [1] 281616 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory distress requiring non-invasive ventilation 287749 0
Patient with respiratory disease requiring non-invasive ventilation in ED 287898 0
Condition category
Condition code
Respiratory 288090 288090 0 0
Other respiratory disorders / diseases
Respiratory 288277 288277 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparison of venous and arterial blood gas analysis values taken prospectivley from patients undergoing non-inavsive ventilation in ED of a teaching hospital. Patients will be observed for a maximum of 24 hours in ED before ward admission. Analysis using bias plot analyses.
Intervention code [1] 285991 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288295 0
Agreement between arterial and venous blood gas parameters pH and pCO2 (bias plot analyses)
Timepoint [1] 288295 0
Up to 3 time points at approx. 2 hourly intervals. Monitoring of progress of ventilatory function while on non-inavsive ventilation is important and serial blood gases are often required at 2-4 hourly intervals. Additional sample sets will be taken when additional blood gas tests are clinically indicated (as determined by the treating doctor).
Secondary outcome [1] 299776 0
NA
Timepoint [1] 299776 0
NA

Eligibility
Key inclusion criteria
Patients requiring non-invasive ventilation in emergency department
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286256 0
Hospital
Name [1] 286256 0
Western Hospital
Country [1] 286256 0
Australia
Primary sponsor type
Hospital
Name
Western Hospital
Address
Gordon Street
Footscray VIC 3011
Country
Australia
Secondary sponsor category [1] 285057 0
None
Name [1] 285057 0
Address [1] 285057 0
Country [1] 285057 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288334 0
Western Health low risk ethics panel
Ethics committee address [1] 288334 0
Ethics committee country [1] 288334 0
Australia
Date submitted for ethics approval [1] 288334 0
27/01/2011
Approval date [1] 288334 0
07/02/2011
Ethics approval number [1] 288334 0
HREC/11/WH/3

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34908 0
Address 34908 0
Country 34908 0
Phone 34908 0
Fax 34908 0
Email 34908 0
Contact person for public queries
Name 18155 0
Anne-Maree Kelly
Address 18155 0
JECEMR Sunhine Hospital, Furlong Road, St Albans VIC 3021
Country 18155 0
Australia
Phone 18155 0
+61383958070
Fax 18155 0
+61393184790
Email 18155 0
[email protected]
Contact person for scientific queries
Name 9083 0
Anne-Maree Kelly
Address 9083 0
JECEMR Sunhine Hospital, Furlong Road, St Albans VIC 3021
Country 9083 0
Australia
Phone 9083 0
+61383958070
Fax 9083 0
+61393184790
Email 9083 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.