Accuracy of Non-contact Thermometry

Hypothermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477357
• Other study ID #: 214661
• Status: Completed
• Start date: April 17, 2018
• Est. completion date: July 31, 2018

Study information

• Verified date: January 2022
• Source: Brighton and Sussex University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia

Intervention

Device:
• Geratherm non Contact thermometer
Temperature taken from subject using non-contact device as per manufacturers instructions

Locations

Country	Name	City	State
United Kingdom	Brighton and Sussex University Hospitals NHS Trust	Brighton	East Sussex

Sponsors (1)

Lead Sponsor	Collaborator
Brighton and Sussex University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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