Accuracy of Non-contact Thermometry

• Sponsor: Brighton and Sussex University Hospitals NHS Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT03477357
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Actual Duration (Months): 3.4
• Patients Per Site Per Month: 10.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hypothermia	Device: Geratherm non Contact thermometer

Study Design

• Study Type: Observational
• Actual Enrollment: 35 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: A Study to Determine the Accuracy of a Non-contact Thermometer in the Perioperative Setting
• Actual Study Start Date: Apr 17, 2018
• Actual Primary Completion Date: Jul 31, 2018
• Actual Study Completion Date: Jul 31, 2018

Outcome Measures

Primary Outcome Measures

1. Core body temperature measurement will be taken from 30 patients to compare non-contact infra-red thermometer to oesophageal temperature probes [12 months]

   Bland Altman analysis to compare the readings of 2 methods of temperature measurement

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brighton and Sussex University Hospitals NHS Trust	Brighton	East Sussex	United Kingdom	TN62DS

Sponsors and Collaborators

• Brighton and Sussex University Hospitals NHS Trust

Investigators

• Principal Investigator: Jack Reid, MBBS, BSUH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brighton and Sussex University Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT03477357
• Other Study ID Numbers: 214661
• First Posted: Mar 26, 2018
• Last Update Posted: Jan 19, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypothermia

Study Results

No Results Posted as of Jan 19, 2022