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Continuous Temperature monitoring for Maintenance of Perioperative Thermoregulation (Co-TEMPT): a pilot study.

Continuous Temperature monitoring for Maintenance of Perioperative Thermoregulation (Co-TEMPT) in adult patients: a pilot study.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000438853
Acronym
Co-TEMPT
Enrollment
102
Registered
2021-04-16
Start date
2021-06-30
Completion date
2022-04-04
Last updated
2022-04-25

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

Conditions

None listed

Brief summary

Temperature imbalance during surgery results in adverse outcomes for patients, however temperature is rarely monitored in accordance with guidelines. One key barrier to regular, consistent and documented temperature monitoring during surgery is a lack of a non-invasive, but accurate temperature monitoring device. This pilot study will assess feasibility of recruitment, protocol fidelity, sample size and process evaluation for a future cluster randomised study testing the impact of a non-invasive, continuous temperature monitoring device upon clinical practice and patient outcomes.

Interventions

On arrival to the pre-operative holding area, and prior to the induction of anaesthesia, the zero heat flux monitoring Bair Hugger™ device will be attached to the forehead, above the orbital ridge. The placement of the device will be undertaken by the registered nurse working in the pre-operative holding area. The Research Nurse will be present for assistance. The device then requires a ramp-up time of three minutes for temperature readings to stabilise. The ZHF (Bair Hugger™) device will be uti

On arrival to the pre-operative holding area, and prior to the induction of anaesthesia, the zero heat flux monitoring Bair Hugger™ device will be attached to the forehead, above the orbital ridge. The placement of the device will be undertaken by the registered nurse working in the pre-operative holding area. The Research Nurse will be present for assistance. The device then requires a ramp-up time of three minutes for temperature readings to stabilise. The ZHF (Bair Hugger™) device will be utilized until patients are assessed as ‘ready for discharge’ from the Post Anaesthetic Care Unit (PACU). Treatment adherence and fidelity will be prospectively monitored and assessed via direct observation.

Sponsors

Queensland University of Technology
Lead SponsorUniversity

Study design

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

Eligibility

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

Inclusion criteria

The patient population will include consenting adults undergoing elective surgery (expected duration > 30 minutes), under general, or neuraxial anaesthesia, with an American Society of Anesthesiologists (ASA) score I-III. The health care professional population will include consenting perioperative nurses, technicians and anaesthetists caring for patient participants.

Exclusion criteria

Patients undergoing surgery with an expected procedural duration of less than 30 minutes, patients undergoing local anaesthesia only or local Anesthesia with sedation, or patients with known sensitivity to adhesives, or forehead rash on the day of admission, will be excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 11, 2026