Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000319572
Ethics application status
Not yet submitted
Date submitted
3/07/2006
Date registered
24/07/2006
Date last updated
24/07/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Development and validation of a diagnostic alarm for monitoring anaesthesia related adverse events
Scientific title
Development and validation of a diagnostic alarm for monitoring anaesthesia related adverse events
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adverse events during anaesthesia 1289 0
Condition category
Condition code
Anaesthesiology 1379 1379 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation of hypovolaemia - for duration of operations
Intervention code [1] 1186 0
Early detection / Screening
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 1880 0
Detection of adverse events
Timepoint [1] 1880 0
Throughout the duration of anaesthesia
Secondary outcome [1] 3323 0
Agreement between computer and clinician, throughout the duration of the anaesthetic.
Timepoint [1] 3323 0

Eligibility
Key inclusion criteria
Patients having moderate to major surgery where blood loss is expected.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 373 0
New Zealand
State/province [1] 373 0

Funding & Sponsors
Funding source category [1] 1511 0
Hospital
Name [1] 1511 0
Auckland City Hospital
Country [1] 1511 0
New Zealand
Funding source category [2] 1512 0
University
Name [2] 1512 0
Auckland University of Technology
Country [2] 1512 0
New Zealand
Primary sponsor type
Individual
Name
Michael Harrison
Address
Country
Secondary sponsor category [1] 1328 0
None
Name [1] 1328 0
None
Address [1] 1328 0
Country [1] 1328 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 2936 0
Auckland City Hospital
Ethics committee address [1] 2936 0
Ethics committee country [1] 2936 0
New Zealand
Date submitted for ethics approval [1] 2936 0
Approval date [1] 2936 0
Ethics approval number [1] 2936 0

Summary
Brief summary
The primary purpose of the protocol is to detect adverse events during anaesthesia using a computer and verify the diagnosis by the clinicians's assessment (in real time)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35465 0
Address 35465 0
Country 35465 0
Phone 35465 0
Fax 35465 0
Email 35465 0
Contact person for public queries
Name 10375 0
Dr. Michael Harrison
Address 10375 0
Department of Anaesthesiology
University of Auckland
Mercy Hospital
Mountain Rd.
Auckland
Country 10375 0
New Zealand
Phone 10375 0
+64 93737599
Fax 10375 0
Email 10375 0
[email protected]
Contact person for scientific queries
Name 1303 0
Dr. Michael Harrison
Address 1303 0
Department of Anaesthesiology
University of Auckland
Mercy Hospital
Mountain Rd.
Auckland
Country 1303 0
New Zealand
Phone 1303 0
+64 93737599
Fax 1303 0
Email 1303 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.