Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000245392
Ethics application status
Approved
Date submitted
9/05/2008
Date registered
14/05/2008
Date last updated
14/05/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical implementation of a head-mounted display for anaesthesia patient monitoring
Scientific title
Effect of anaesthetists' use of head-mounted displays vs. standard monitoring on visual attention, latency of response to events, and rated non-technical skills.
Universal Trial Number (UTN)
Trial acronym
HMDClin1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effect of a head-mounted display on anaesthetist access to patient vital sign information when anaesthetistis is in constrained positions 3114 0
Condition category
Condition code
Anaesthesiology 3276 3276 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The clinical trial will test the effectiveness of a head-mounted display in supporting anaesthetist activity in the operating theatre. The head-mounted display will be the Microvision Nomad(tm) see-through monocular display.

Trial aims are to do the following:

1. Implement a clinical prototype of a monitoring display using an HMD connected to a Philips IntelliVue MP70 patient monitor.
2. Provide participants with enough exposure to the HMD that they can develop new scanning patterns that make specific use of the HMD.
3. Evaluate the HMD under clinical circumstances, as opposed to the simulated OR.
4. Compare the performance of participants across anaesthesia lists during which they do vs. do not wear the head-mounted display.

Each participant will be studied over six sessions, the sessions no less than a day apart and usually no more than a week apart. The study itself will be completed by 31 December 2008.
Intervention code [1] 2857 0
Behaviour
Comparator / control treatment
The effectiveness of the head-mounted display will be evaluated using a crossover design. Performance and behaviour will be compared across lists during which the anaesthetist does vs. does not wear the head-mounted display.
Control group
Active

Outcomes
Primary outcome [1] 4164 0
Rating of anaesthetist's effectiveness using objective scoring system (eg. the Anaesthetists' Non-Technical Skills or ANTS rating system)
Timepoint [1] 4164 0
Ratings will be made by subject-matter experts after the trial is completed on the basis of video collected during the trial.
Primary outcome [2] 4165 0
Frequency with which anaesthetists turn their heads to examine the standard patient monitoring system and pattern over time of head-turns.
Timepoint [2] 4165 0
Head-turns will be coded after completion of the trial on the basis of video collected during the trial.
Primary outcome [3] 4166 0
Latency for anaesthetists to respond to changes in patient vital signs or other significant events.
Timepoint [3] 4166 0
Latency to respond will be measured after completion of the trial on the basis of video collected during the trial.
Secondary outcome [1] 7022 0
Anaesthetists' subjective satisfaction with the head-mounted display.
Timepoint [1] 7022 0
Satisfaction will be measured after completion of the trial on the basis of questionnaire responses collected during the trial.

Eligibility
Key inclusion criteria
Participants must be anaesthesia consultants or senior registrars working at Royal Adelaide Hospital. Participants must be able to comfortably view the patient monitoring information on the head-mounted display as well as the outer field of view. Participants who have prior experience with the head-mounted display from previous simulator-based experiments are preferred.
Minimum age
26 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria are:
1. Inability to comfortably view patient vital signs on the head-mounted display.
2. Inability to wear the head-mounted display due to interference with glasses or discomfort caused by the headgear.

Study design
Purpose of the study
Treatment
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
Crossover
Other design features
Six participants will experience monitoring both with and without the head-mounted display. Participants will be allocated to one of two sequences of conditions in alternating order determined by order of starting the experiment, until there are three participants in each sequence.
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3356 0
Government body
Name [1] 3356 0
Australian Research Council
Country [1] 3356 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
St Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 3004 0
Hospital
Name [1] 3004 0
Royal Adelaide Hospital
Address [1] 3004 0
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country [1] 3004 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5382 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 5382 0
Ethics committee country [1] 5382 0
Australia
Date submitted for ethics approval [1] 5382 0
Approval date [1] 5382 0
04/03/2008
Ethics approval number [1] 5382 0
RAH Protocol No: 080301
Ethics committee name [2] 5396 0
The University of Queensland MREC
Ethics committee address [2] 5396 0
Ethics committee country [2] 5396 0
Australia
Date submitted for ethics approval [2] 5396 0
Approval date [2] 5396 0
20/03/2008
Ethics approval number [2] 5396 0
2008000475

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

Contacts
Principal investigator
Name 28568 0
Address 28568 0
Country 28568 0
Phone 28568 0
Fax 28568 0
Email 28568 0
Contact person for public queries
Name 11725 0
Professor Penelope Sanderson
Address 11725 0
Professor Penelope Sanderson
School of Psychology
The University of Queensland
St Lucia, QLD 4072
Country 11725 0
Australia
Phone 11725 0
+61 7 3365-7196
Fax 11725 0
+61 7 3365-4466
Email 11725 0
[email protected]
Contact person for scientific queries
Name 2653 0
Mr David Liu
Address 2653 0
School of ITEE
The University of Queensland
St Lucia, QLD 4072
Country 2653 0
Australia
Phone 2653 0
+61 7 3365-6737
Fax 2653 0
+61 7 3365-4466
Email 2653 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
SourceTitleYear of PublicationDOI
Dimensions AIMonitoring with Head-Mounted Displays in General Anesthesia2010https://doi.org/10.1213/ane.0b013e3181d3e647
N.B. These documents automatically identified may not have been verified by the study sponsor.