NCT03477357

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2017

Completed
9 months until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

April 17, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

July 11, 2017

Last Update Submit

January 17, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Temperature taken from subject using non-contact device as per manufacturers instructions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brighton and Sussex University Hospitals NHS Trust

Brighton, East Sussex, TN62DS, United Kingdom

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jack Reid, MBBS

    BSUH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2017

First Posted

March 26, 2018

Study Start

April 17, 2018

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Data will be anonymised and analysed later.

Locations