Accuracy of zero-flux and ingestible thermometry

  • Research type

    Research Study

  • Full title

    A study to determine the accuracy of zero-flux and ingestible thermometers in the perioperative setting

  • IRAS ID

    150071

  • Contact name

    C Mark Harper

  • Contact email

    mark.harper@doctors.org.uk

  • Sponsor organisation

    Brighton Health Care NHS Trust

  • Clinicaltrials.gov Identifier

    NCT02121574

  • Clinicaltrials.gov Identifier

    14/EE/1016, NRES COMMITTEE EAST OF ENGLAND - NORFOLK

  • Research summary

    When a patient is anaesthetised for an operation, their body temperature falls. Managing body temperature properly by keeping it within normal limits has been shown to improve recovery from surgery.

    A vital part of managing temperature is accurate measurement. Several methods exist, which consist of invasive and non invasive methods. 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 awake during their operations, and it is inappropriate to insert a urinary catheter should it not be otherwise needed.

    This study will compare 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.

    We will 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.

    During operations, temperature is routinely measured according to NICE guidelines with thermometers placed in the nose or oesophagus. We will be comparing the two new devices accuracy against these methods.

    We will record measurements from each device every minute throughout the operation in 20 patients. We will then perform statistical tests to check their accuracy.

  • REC name

    East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

  • REC reference

    14/EE/1016

  • Date of REC Opinion

    18 Jun 2014

  • REC opinion

    Further Information Favourable Opinion