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Trial registered on ANZCTR


Registration number
ACTRN12613000144718
Ethics application status
Not yet submitted
Date submitted
5/02/2013
Date registered
6/02/2013
Date last updated
6/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study to assess an evidence-based anaesthesia monitoring system
Scientific title
A pilot study in patients undergoing anaesthesia for major surgery who will be monitored using an additional computer based system (EBMi); whether the EBMi system has any advantages over conventional monitoring will be assessed by the anaesthetist in charge of the patients care.
Secondary ID [1] 281899 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adverse events during anaesthesia 288301 0
Condition category
Condition code
Anaesthesiology 288645 288645 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of novel software to augment present anaesthesia monitoring.
The software includes the ability to detect / diagnose various adverse events during anaesthesia...including hypovolaemia, age and disease related hypotension, Cushing response, sympathetic response, low anaesthetic concentration, damped arterial trace. The alerts are presented visually and audibly in plain English. The software will run for the duration of the anaesthetic .
Intervention code [1] 286469 0
Early detection / Screening
Comparator / control treatment
This is a pilot study of an auxiliary monitoring system and as such it will be assessed for its 'usability' and ability to detect adverse events; for this pilot study it is not being compared with any other system
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288800 0
1. The software functions without failure / downtime

Failure or downtime – a simple observation that the software keeps running despite artefacts in the monitored data
Timepoint [1] 288800 0
End of surgery
Primary outcome [2] 288801 0
2. The degree of agreement between the clinician and the software using Kappa analysis
Timepoint [2] 288801 0
End of the pilot study
Primary outcome [3] 288802 0
3 Determination of specificity / sensitivity of diagnoses

Each alert will be assessed by the clinician(s) and will be classified as a True positive or False positive. This will be done using clinical acumen/experience
Timepoint [3] 288802 0
End of study period
Secondary outcome [1] 301028 0
Nil
Timepoint [1] 301028 0
Nil

Eligibility
Key inclusion criteria
Adult - aged over 16 years
Able to give consent
Major surgery involving the use of intra-arterial monitoring
Minimum age
16 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Younger than 16 years of age

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The patient’s that are potentially able to be audited will be noted at the time of the preoperative visit by the anaesthetist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
This is an observational interventional study. The intervention is the use of an additional monitoring system that may give the anaesthetist more information than normal. The anaesthetist is in sole charge of the management of the patient.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Kappa analysis and free text observational notes

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4851 0
New Zealand
State/province [1] 4851 0
South Island

Funding & Sponsors
Funding source category [1] 286692 0
Self funded/Unfunded
Name [1] 286692 0
N/A
Address [1] 286692 0
N/A
Country [1] 286692 0
New Zealand
Primary sponsor type
Individual
Name
Michael Harrison
Address
University Department of Surgery and Anaesthesia, Otago University (Wellington)
21 Mein St., Newtown, Wellington, 6242
North Island
Country
New Zealand
Secondary sponsor category [1] 285461 0
None
Name [1] 285461 0
None
Address [1] 285461 0
None
Country [1] 285461 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288755 0
HDEC New Zealand
Ethics committee address [1] 288755 0
HDEC
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington
Ethics committee country [1] 288755 0
New Zealand
Date submitted for ethics approval [1] 288755 0
14/02/2013
Approval date [1] 288755 0
Ethics approval number [1] 288755 0

Summary
Brief summary
The anaesthesia monitors we now use have not changed significantly over the last 25 years. We are still presented with simple trend displays of various parameters over time, digital values that are updated every 10s and waveforms of some variables. There is virtually no interpretation of these variables and it is very easy to miss significant changes that take place slowly over time.
The Evidence-Based monitor software follows trend in key variables and detects patterns of changes in these variable that are associated with 'organised' physiological responses and alerts the anaesthetist to the possibility of an adverse state.
This software has been tested off-line on two patient databases (both had ethical approval for data collection) but has never been tested in real-time in an operating theatre.
Objectives

1. To show that the software will run continuously without breakdowns
2. To assess its ease of use
3. To assess its usefulness

a) Did it highlight events that may have been missed because of other factors

b) Did it stimulate a change in patient management.

4. To determine the correctness of the advice
a) Did it suggest diagnoses that were incorrect (False positives)
b) Did it fail to suggest a diagnosis when the clinician expected a response (False negative)
c) Did it 'keep quiet' when nothing was happening (True negatives)
d) Did it correctly diagnose adverse events for which it is designed (True positive)

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37642 0
Dr Michael Harrison
Address 37642 0
Department of Surgery and Anaesthesia,
University of Otago (Wellington)
21 Mein St., Newtown, Wellington, 6242
North Island
Country 37642 0
New Zealand
Phone 37642 0
+64-21-640-618
Fax 37642 0
Email 37642 0
michael.harrison@otago.ac.nz
Contact person for public queries
Name 37643 0
Dr Michael Harrison
Address 37643 0
Department of Surgery and Anaesthesia,
University of Otago (Wellington)
21 Mein St., Newtown, Wellington, 6242
North Island
Country 37643 0
New Zealand
Phone 37643 0
+64-21-640-618
Fax 37643 0
Email 37643 0
michael.harrison@otago.ac.nz
Contact person for scientific queries
Name 37644 0
Dr Michael Harrison
Address 37644 0
Department of Surgery and Anaesthesia,
University of Otago (Wellington)
21 Mein St., Newtown, Wellington, 6242
North Island
Country 37644 0
New Zealand
Phone 37644 0
+64-21-640-618
Fax 37644 0
Email 37644 0
michael.harrison@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
No Results