A pilot study comparing the zero-heat-flux temperature monitoring device to oesophageal temperature monitoring in orthopaedic surgery.

Phase 4

Completed

• Conditions: Orthopaedic surgery; Temperature monitoring; Surgery - Other surgery

• Registration Number: ACTRN12619000842167
• Lead Sponsor: Queensland University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-12
• Study Completion: 2019-07-03
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients undergoing elective orthopaedic surgery
Endotracheal tube placement with oesophageal temperature monitoring
General anaesthesia

Exclusion Criteria

Forehead/neck rash or infection
Unexpected blood loss
Oesophageal varices
American Society of Anaesthesiologists (ASA) score >III
Patients not expected to receive endotracheal tube placement
Surgery under neuraxial anaesthesia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement accuracy of core temperature: assessed by comparing readings from zero heat flux monitoring device and oesophageal monitoring device. Agreement between monitoring routes will be analysed using a repeated measures Bland Altman random effects method (via MedCalc™). The acceptable limit of agreement between measurements will be +/- 0.5°C, which is the conventional acceptable limit of agreement for temperature monitoring devices. The mean difference between devices, the variability of the individual differences, and the intra-class correlation coefficient (ICC) will be reported,<br>[Intraoperative temperature monitoring to first recorded temperature in Post Anaesthetic Care Unit. ]