Accuracy of Non-contact Thermometry

A Study to Determine the Accuracy of a Non-contact Thermometer in the Perioperative Setting

Subjects will be admitted to hospital the evening prior, or the morning of surgery, whereupon they will undergo standard admission processes, including pre-operative assessment by the anaesthetist assigned to that list (One of the two study authors). The anaesthetist will then explain the study again, reiterating the potential risks and benefits of the study to the patient themselves, and to the population as a whole. Consent will be sought at this point.

Patients will be transferred to theatre, anaesthetised and operated on as per normal practice. Inclusive of this, in accordance with NICE guidelines, patients will have a nasal or oesophageal Doppler probe inserted to accurately measure core temperature. At this point, patients enrolled in the study will have temperature measurements taken every minute from the oesophageal probe and non-contact thermometers.

If the patients requested it previously, they will be informed of the results of the study at a later date.

Statistics will then be carried out on the data to compare accuracy of the two novel methods to the oesophageal probe.

Study Overview

• Status: Completed
• Conditions: Hypothermia
• Intervention / Treatment: Device: Geratherm non Contact thermometer

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United Kingdom
  • East Sussex
    • Brighton, East Sussex, United Kingdom, TN62DS
      • Brighton and Sussex University Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be patients undergoing elective gynaecological, vascular or urological surgery at the Royal Sussex County Hospital, and as such will be seen at a pre-operative assesment clinic as part of their normal work up for theatre

Description

Inclusion Criteria:

• Participants will be patients undergoing elective gynaecological, vascular or urological surgery at the Royal Sussex County Hospital, and as such will be seen at a pre-operative assessment clinic as part of their normal work up for theatre.

Exclusion Criteria:

- Lacking mental capacity Not speaking English Malignancy in medical history Undergoing open abdominal surgery

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Core body temperature measurement will be taken from 30 patients to compare non-contact infra-red thermometer to oesophageal temperature probes	Bland Altman analysis to compare the readings of 2 methods of temperature measurement	12 months

Collaborators and Investigators

• Sponsor: Brighton and Sussex University Hospitals NHS Trust
• Investigators: Principal Investigator: Jack Reid, MBBS, BSUH

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 17, 2018
• Primary Completion (ACTUAL): July 31, 2018
• Study Completion (ACTUAL): July 31, 2018

Study Registration Dates

• First Submitted: July 11, 2017
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (ACTUAL): March 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: 214661

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be anonymised and analysed later.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No