Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001129471
Ethics application status
Approved
Date submitted
5/09/2025
Date registered
15/10/2025
Date last updated
15/10/2025
Date data sharing statement initially provided
15/10/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the accuracy of an expert monitoring system that detects early adverse changes during anaesthesia for routine surgery.
Scientific title
Evaluation of the precision of an expert system, EDDI (Early Detection of Diagnostic Information), used with anaesthesia monitors for patients undergoing routine surgery.
Secondary ID [1] 315306 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a follow up study to ACTRN12613000144718 with much advanced software

Health condition
Health condition(s) or problem(s) studied:
Patients with unstable physiology undergoing routine surgery. 338779 0
Condition category
Condition code
Anaesthesiology 335073 335073 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early Detection of Diagnostic Information (EDDI) software will be used; it is written in the C++ programming language. It uses existing equipment (oximeter, BP monitor) to monitor the patient and provide additional processed diagnostic data for the anaesthetist,
Patients enrolled with the study will receive additional monitoring of blood pressure, heart rate, temperature, breathing rate and oxygen and carbon dioxide levels. The software is on a laptop attached by a cable to the standard, routine monitor. The expert system is set up by an anaesthetic technician or the anaesthetist.
This additional monitoring occurs from the beginning to the end of anaesthesia, aligning with the standard clinical process. Preparations for monitoring, including attaching the expert system, are completed before anaesthesia begins.
No extra tests or medication is required and all anaesthetic procedures follow usual clinical practice.
Intervention code [1] 332029 0
Early detection / Screening
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342710 0
The accuracy of EDDI-generated alerts to detect hypovolaemia when compared with the clinician's assessment.
Timepoint [1] 342710 0
Anaesthesia will be carried out in a routine manner and the data collection will start at the beginning of the anaesthetic and finish at the end of surgery.
Primary outcome [2] 343039 0
The accuracy of EDDI-generated alerts to detect a fall in cardiac outputwhen compared with the clinician's assessment.
Timepoint [2] 343039 0
Anaesthesia will be carried out in a routine manner, and the data collection will start at the beginning of the anaesthetic and finish at the end of surgery.
Primary outcome [3] 343040 0
The accuracy of EDDI-generated alerts to detect a sympathetic response (normally in response to a noxious stimulus) when compared with the clinician's assessment.
Timepoint [3] 343040 0
Anaesthesia will be carried out in a routine manner, and the data collection will start at the beginning of the anaesthetic and finish at the end of surgery.
Secondary outcome [1] 451874 0
An assessment of the utility of the expert system will be made by a simple questionnaire, designed for this study, for the anaesthetist to complete, including free text comments.
Timepoint [1] 451874 0
The utility of the system will be assessed after each clinical session/day, and also at the end of the study.

Eligibility
Key inclusion criteria
Patients undergoing routine surgery who are over the age of 16 years.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Written consent is required, No consent - no participation

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Cohen's Kappa
Matthews correlation coefficient
Questionnaire - simple quantitative and qualitative statistics

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/01/2026
Actual
Date of last participant enrolment
Anticipated
10/01/2027
Actual
Date of last data collection
Anticipated
10/01/2027
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 27333 0
New Zealand
State/province [1] 27333 0
North Island

Funding & Sponsors
Funding source category [1] 319880 0
Self funded/Unfunded
Name [1] 319880 0
Unfunded
Country [1] 319880 0
Primary sponsor type
Individual
Name
Dr. Matt Kirk-Jones - North Shore Hospital
Address
Country
New Zealand
Secondary sponsor category [1] 322409 0
Individual
Name [1] 322409 0
Dr. Michael Harrison - University of Auckland
Address [1] 322409 0
Country [1] 322409 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318433 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 318433 0
Ethics committee country [1] 318433 0
New Zealand
Date submitted for ethics approval [1] 318433 0
05/09/2024
Approval date [1] 318433 0
02/09/2025
Ethics approval number [1] 318433 0
20849

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

Contacts
Principal investigator
Name 144174 0
Dr Matthew Kirk-Jones
Address 144174 0
Dept. Anaesthesia, North Shore Hospital, 124 Shakespeare Road, Takapuna, Auckland 0620
Country 144174 0
New Zealand
Phone 144174 0
+64 21 1766054
Fax 144174 0
Email 144174 0
[email protected]
Contact person for public queries
Name 144175 0
Matthew Kirk-Jones
Address 144175 0
Dept. Anaesthesia, North Shore Hospital, 124 Shakespeare Road, Takapuna, Auckland 0620
Country 144175 0
New Zealand
Phone 144175 0
+64 9 4868 9000
Fax 144175 0
Email 144175 0
[email protected]
Contact person for scientific queries
Name 144176 0
Matthew Kirk-Jones
Address 144176 0
Dept. Anaesthesia, North Shore Hospital, 124 Shakespeare Road, Takapuna, Auckland 0620
Country 144176 0
New Zealand
Phone 144176 0
+64 9 4868 9000
Fax 144176 0
Email 144176 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The data will be deidentified and the data would generally not be comprehensible without an anaesthetist's interpretation.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Notification of Ethics Approval.pdf
Informed consent form    participant-information-sheet-consent-form.doc
Study protocol    EDDI Assessment Protocol.docx
Statistical analysis plan    EDDI Study data analysis (1).docx


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.