Accuracy of Zero-flux and Ingestible Thermometers

NCT02121574 | Completed

• 1 other identifier: WKR0-2013-0051
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Background When a patient is anesthetised and undergoes an operation, their body temperature falls. Managing a body temperature properly by keeping it within normal limits has been shown to improve recovery from surgery. A vital part of managing temperature is being able to measure it properly. There are several ways of doing so, which consist of invasive methods such as temperature probes in the oesophagus and bladder, and non invasive methods such as infrared scanners and ear canal probes. During an operation, temperature changes as small as 0.5 °C can affect outcomes but, currently, only invasive methods are reliable enough to detect this. Oesophageal probes can't be used in patients who are not anaesthetised during their operations, and it is inappropriate to insert a urinary catheter should it not be otherwise needed. The purpose of this study is to look at two new methods of measuring a patient's temperature which would help us in these situations. The first is called zero-flux thermometry and involves placing an adhesive pad to the forehead, which gives constant measurement of a patient's core temperature. The second involves swallowing an ingestible capsule that is no bigger than a normal pill. This technique has been very useful in research tracking a patient's core temperature as they are transferred through different areas over a longer period of time. Whilst these two methods are potentially very useful, they have never been tested on hospital patients. Aims: The investigators want to determine whether readings from these thermometers are accurate enough to be used in patients before, during and after surgery. Should they prove to be sufficiently accurate it will allow us to improve patient care through both clinical practice and research. Plan: During operations, temperature is routinely measured in line with NICE guidelines with a thermometer placed in the nose or oesophagous. The investigators will not be changing routine practice in any way, but checking measurements from the new devices against the proven, routine ones. The investigators plan to record measurements from each device every minute throughout the operation in 20 patients. The investigators will then perform statistical tests to check their accuracy. Study Hypothesis: Zero flux and ingestible thermometers are not significantly different at detecting patients body temperature than oesophageal temperature probes

Conditions

Surgery; Hypothermia; Anesthesia

Keywords

Surgery; thermometers; Hypothermia; anesthesia; temperature

Outcome Measures

Primary Outcomes (1)

• Comparing the accuracy of zero flux and ingestible thermometers to oesophageal temperature probes.

  6 months

Study Arms (1)

Zero-flux and ingestible thermometer

Ingestion of a capsule thermometer pre-operatively Attachment of a zero flux temperature electrode intraoperatively Standard oesophageal thermometer

Device: Zero flux and ingestible thermometers

Interventions

Zero flux and ingestible thermometers DEVICE

Zero-flux and ingestible thermometer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Brighton and Sussex University Hospitals NHS Trust: lead

Study Sites (2)

Royal Sussex County Hospital

Brighton, East Sussex, BN2 5BE, United Kingdom

Location

Royal Sussex County Hospital

Brighton, East Sussex, TN62DS, United Kingdom

Location

Related Publications (1)

• Jack JM, Ellicott H, Jones CI, Bremner SA, Densham I, Harper CM. Determining the accuracy of zero-flux and ingestible thermometers in the peri-operative setting. J Clin Monit Comput. 2019 Dec;33(6):1113-1118. doi: 10.1007/s10877-019-00252-9. Epub 2019 Jan 8.

  PMID: 30623279 DERIVED

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James M Jack, MBBS BSc

  BSUH NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr C. Mark Harper Consultant Anaesthetist

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 23, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

GB (2)