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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626001113347
Enrollment
35
Registered
2026-09-08
Start date
2026-11-01
Completion date
2027-10-30
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Marc Schnekenburger, Bayside Health, Alfred Care Group
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026