ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626001113347

Ethics application status

Approved

Date submitted

28/07/2026

Date registered

8/09/2026

Date last updated

8/09/2026

Date data sharing statement initially provided

8/09/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

Non-invasive continuous temperature monitoring in major burns patients in the Alfred Emergency Department

Scientific title

Non-invasive continuous temperature monitoring in major burns patients in the Alfred Emergency Department

Additional trial identifiers [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Major Burn injury

Hypothermia

Condition category

Condition code

Emergency medicine

Resuscitation

Injuries and Accidents

Burns

Skin

Other skin conditions

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

Non-invasive continuous temperature measurement with the Cosinuss c-med° alpha ear sensor. The probe consists of a sensor head that is connected to a processing unit behind the ear (similar to a hearing aid). The sensor will be placed into the external auditory canal by a critical care nurse, an emergency physician or burns liaison nurse (BLN).. The participants will wear the sensor while they stay in the emergency department only. During this time their temperature will be monitored. The sensor will be removed when they are transferred to intensive care unit (ICU) or operating theatre (OT). After use the sensor is to be cleaned with an appropriate disinfection and can be reused.

All patients will have standard care and temperatures will be measured using a temporal arterial thermometer (TAT) or invasive probe as is routine clinical practice.

The TAT is a non-invasive device that measures body temperature by scanning the temporal artery on the forehead with infrared sensors. For invasive measurements there are two different probes available, an oesophageal probe inserted into the food-pipe or a bladder probe inserted through a urinary catheter.
The TAT is often used in the initial phase. During the busy resuscitation phase, TAT measurements are often not documented in close intervals. In patients with severe burns or intubated patients an invasive probe is inserted. From then on temperatures are measured continuously and recorded more regularly.

Intervention code [1]

Diagnosis / Prognosis

Intervention code [2]

Treatment: Devices

Description of the comparator or control

Comparison with our standard procedures. Discrete measurements of TAT and continuous data from bladder or oesophageal temperature probe.

The comparison is not used as a validation study. The temperature monitoring accuracy of the device has been validated previously.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome variable will be detection of temperatures (hypothermia) outside the optimal zone (< 36°C) The temperature will be measured continuously and non-invasive by the ear sensor. The temperature data will be compared with standard measurements from discrete TAT (temporal arterial thermometer) and continuous data from bladder or oesophageal invasive probe if inserted.

Timepoint [1]

Measurement during reception and resuscitation in the Emergency Department. Once the patient leaves the Emergency Department the ear probe will be removed.

Secondary outcome [1]

Mortality

Timepoint [1]

During current admission

Secondary outcome [2]

ICU admission

Timepoint [2]

During current admission

Secondary outcome [3]

ICU Length of Stay LOS

Timepoint [3]

During current admission

Secondary outcome [4]

Warming procedures used in the emergency department

Timepoint [4]

During time in the emergency department

Secondary outcome [5]

Hospital length of stay

Timepoint [5]

at completion of study

Eligibility

Key inclusion criteria

All patients presenting to the Alfred Emergency and Trauma Centre will be assessed for eligibility.
Inclusion criteria:
• Major burns to total body surface area (TBSA) equal to or greater than 20%
• Adult patients equal to or older than 18 years

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

- Burns less than 20% TBSA
- Presentation to the Burns Service Hospital) more than 12 hours after the burn
- Non-thermal injuries or other medical skin loss

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

This is a descriptive pilot study without sample size calculations. We will use a convenience sample of all eligible patients over a one-year period.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/11/2026

Actual

Date of last participant enrolment

Anticipated

30/10/2027

Actual

Date of last data collection

Anticipated

31/12/2027

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Alfred Hospital

Address [1]

Country [1]

Australia

Primary sponsor type

Individual

Name

Marc Schnekenburger, Bayside Health, Alfred Care Group

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Ethics Committee

Ethics committee address [1]

https://www.alfredhealth.org.au/research/ethics-research-governance

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/05/2024

Approval date [1]

30/04/2026

Ethics approval number [1]

Project 285/24

Summary

Brief summary

This study will test whether a non-invasive ear sensor can help track body temperature more closely in adults with major burns who come to the Alfred Emergency and Trauma Centre. 

Currently, temperature is checked at set points using a forehead thermometer, or continuously through invasive probes inserted into the food pipe or bladder. The researchers expect that using this wearable, easy-to-apply ear sensor for continuous monitoring will pick up more episodes of temperature outside the recommended range, including hypothermia (low body temperature). 

Hypothermia is common in patients with large burns and has been associated with poorer outcomes. The aim of this interventional study is to measure these temperature episodes and to look at whether detecting them affects how patients are treated and how they recover, including their time in intensive care and hospital.

Trial website

Trial related presentations / publications

Public notes

Risk assessment: 
The c-med° alpha telemetry and medical device software has been EU certified and complied with Regulation (EU) 2017/745 on medical devices (MDR). During the initial application and study set up it did not hold TGA approval. A comprehensive risk assessment was performed by Alfred Health. It identified a potential risk of infection transmission and risk mitigation strategies were developed. The sensor is only to be cleaned with a solution of no less than 70% isopropyl alcohol concentration and it should be used preferably on ear with intact skin. The approved residual risk rating has been deemed low risk. 
After the internal risk assessment had been finalised, the sensor also received TGA approval.

Contacts

Principal investigator

Name

Mr Marc Schnekenburger

Address

The Alfred Hospital, 55 Commercial Road, Melbourne 3004 VIC

Country

Australia

Phone

+61 3 9076 0575

Fax

[email protected]

Contact person for public queries

Name

Marc Schnekenburger

Address

The Alfred Hospital, 55 Commercial Road, Melbourne 3004 VIC

Country

Australia

Phone

+61 3 9076 0575

Fax

[email protected]

Contact person for scientific queries

Name

Marc Schnekenburger

Address

The Alfred Hospital, 55 Commercial Road, Melbourne 3004 VIC

Country

Australia

Phone

+61 3 9076 0575

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: There are no plans for sharing or data transfer.

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.

Trial Review

Documents added manually

Documents added automatically