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Trial record 5 of 5971 for:    zero

Accuracy of Zero-flux and Ingestible Thermometers

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ClinicalTrials.gov Identifier: NCT02121574
Recruitment Status : Completed
First Posted : April 23, 2014
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Dr C. Mark Harper, Brighton and Sussex University Hospitals NHS Trust

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


Condition or disease Intervention/treatment
Surgery Hypothermia Anesthesia Device: Zero flux and ingestible thermometers

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 30 participants
Time Perspective: Cross-Sectional
Official Title: A Study To Determine The Accuracy Of Zero-Flux And Ingestible Thermometers In The Perioperative Setting
Study Start Date : September 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Comparing the accuracy of zero flux and ingestible thermometers to oesophageal temperature probes. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121574


Locations
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United Kingdom
Royal Sussex County Hospital
Brighton, East Sussex, United Kingdom, BN2 5BE
Royal Sussex County Hospital
Brighton, East Sussex, United Kingdom, TN62DS
Sponsors and Collaborators
Brighton and Sussex University Hospitals NHS Trust
Investigators
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Principal Investigator: James M Jack, MBBS BSc BSUH NHS Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr C. Mark Harper, Dr C. Mark Harper Consultant Anaesthetist, Brighton and Sussex University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02121574     History of Changes
Other Study ID Numbers: WKR0-2013-0051
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

Keywords provided by Dr C. Mark Harper, Brighton and Sussex University Hospitals NHS Trust:
Surgery
thermometers
Hypothermia
anesthesia
temperature

Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes
Signs and Symptoms