SurgeryNCT02121574
Accuracy of Zero-flux and Ingestible Thermometers
An observational study of Surgery and Hypothermia, run by Brighton and Sussex University Hospitals NHS Trust at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery, Hypothermia, Anesthesia
- What is being tested?
- Zero flux and ingestible thermometers
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2014to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Lacking mental capacity
- Not speaking English
- Malignancy in medical history
- Undergoing open abdominal surgery
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Sussex County Hospital
Brighton, East Sussex, BN2 5BE
Royal Sussex County Hospital
Brighton, East Sussex, TN62DS
About this study
Official title: A Study To Determine The Accuracy Of Zero-Flux And Ingestible Thermometers In The Perioperative Setting
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.
Read more
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
Read the detailed description
Summary:
The study has been designed to provide information on the suitability and accuracy of two methods of temperature measurement in the perioperative period.
Background:
Good perioperative temperature management is an important means of improving patient outcome [1].
An essential part of optimal management is accurate temperature measurement. The gold standard is pulmonary artery catheter (PAC) measurement. However, these are used infrequently in British practice due to the high rates of associated complications. Urinary bladder and oesophageal temperatures are sufficiently accurate but are unsuitable for many patients [2]. For example it is not possible to use oesophageal probes in awake patients and many patients are not catheterised.
Although non-invasive and relatively cheap means of measuring temperature (such as aural canal probes and infrared scanners) exist, they are neither accurate nor consistent enough to distinguish the 0.5˚C differences which have a significant effect on patient outcomes [2].
In this study, the investigators plan to look at two methods of temperature measurement which potentially offer significant improvements to surgical care.
The first is a new method known as zero-flux thermometry. This is completely non-invasive, involving no more than placing an adhesive pad to the forehead. Connected up to a monitor, this will equilibrate with the patient's core temperature and give a constant read-out.
The second is an ingestible capsule. These have become an important tool for measuring both hypothermia and hyperthermia in other settings. Their accuracy has not, however, been tested in hospital patients. This technology, although too expensive for routine use, offers significant advantages for research as they can provide a constant record of temperature throughout the patient's stay in hospital. For example, the investigators' audit data show that if patients admitted with fractured neck of femur become hypothermic at any time, their mortality increases. Subsequent to this we showed that patient temperatures drop significantly between ambulance, A\&E and admission to the ward. These parts of the patient journey are possible targets for the prevention of hypothermia and the continuous monitoring offered by these devices will allow us to accurately test the efficacy of the interventions.
Aims and objectives:
The aim of this study is to determine the accuracy in the perioperative period of zero-flux and ingestible temperature readings.
Previous studies have shown that oesophageal and nasopharyngeal measurements can be taken as an accurate reflection of core temperature [2]. The consistency and accuracy of the other two will be compared to this.
Plan of investigation:
This study will be purely observational. There will be no interference with current practice. Nasopharyngeal/oesophageal probes are routinely placed, according to NICE guidelines, in these patients. The zero-flux thermometer is non-invasive and the ingestible capsule no bigger than a pill, so neither provide any additional risk to the patient.
Temperature readings will be downloaded from each of the three devices with a maximum interval of 1 minute. The investigators have calculated that readings from 15 subjects will provide sufficient power. The investigators plan to recruit 20 patients. Analysis of agreement between the methods will be performed as suggested by Bland and Altman[3].
- Conditions
- Surgery, Hypothermia, Anesthesia
- Being tested
- Zero flux and ingestible thermometers
- Keywords
- Surgery, thermometers, Hypothermia, anesthesia, temperature
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zero flux and ingestible thermometersDevice
| Study group | Role | What they receive |
|---|---|---|
| Zero-flux and ingestible thermometer | Ingestion of a capsule thermometer pre-operatively Attachment of a zero flux temperature electrode intraoperatively Standard oesophageal thermometer Receives: Device: Zero flux and ingestible thermometers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the accuracy of zero flux and ingestible thermometers to oesophageal temperature probes.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brighton and Sussex University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr C. Mark Harper, Brighton and Sussex University Hospitals NHS Trust
- Investigators
- James M Jack, MBBS BSc, Principal investigator, BSUH NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121574
- Sponsor's protocol ID
- WKR0-2013-0051
- Status last verified
- Jan 2016
- First submitted
- 22 Apr 2014
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30623279
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study To Determine The Accuracy Of Zero-Flux And Ingestible Thermometers In The Perioperative Setting
- ClinicalTrials.gov ID
- NCT02121574
- Acronym / sponsor ID
- WKR0-2013-0051
- Conditions
- Surgery, Hypothermia, Anesthesia
- Keywords
- Surgery, thermometers, Hypothermia, anesthesia, temperature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Brighton and Sussex University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Summary:
The study has been designed to provide information on the suitability and accuracy of two methods of temperature measurement in the perioperative period.
Background:
Good perioperative temperature management is an important means of improving patient outcome [1].
An essential part of optimal management is accurate temperature measurement. The gold standard is pulmonary artery catheter (PAC) measurement. However, these are used infrequently in British practice due to the high rates of associated complications. Urinary bladder and oesophageal temperatures are sufficiently accurate but are unsuitable for many patients [2]. For example it is not possible to use oesophageal probes in awake patients and many patients are not catheterised.
Although non-invasive and relatively cheap means of measuring temperature (such as aural canal probes and infrared scanners) exist, they are neither accurate nor consistent enough to distinguish the 0.5˚C differences which have a significant effect on patient outcomes [2].
In this study, the investigators plan to look at two methods of temperature measurement which potentially offer significant improvements to surgical care.
The first is a new method known as zero-flux thermometry. This is completely non-invasive, involving no more than placing an adhesive pad to the forehead. Connected up to a monitor, this will equilibrate with the patient's core temperature and give a constant read-out.
The second is an ingestible capsule. These have become an important tool for measuring both hypothermia and hyperthermia in other settings. Their accuracy has not, however, been tested in hospital patients. This technology, although too expensive for routine use, offers significant advantages for research as they can provide a constant record of temperature throughout the patient's stay in hospital. For example, the investigators' audit data show that if patients admitted with fractured neck of femur become hypothermic at any time, their mortality increases. Subsequent to this we showed that patient temperatures drop significantly between ambulance, A\&E and admission to the ward. These parts of the patient journey are possible targets for the prevention of hypothermia and the continuous monitoring offered by these devices will allow us to accurately test the efficacy of the interventions.
Aims and objectives:
The aim of this study is to determine the accuracy in the perioperative period of zero-flux and ingestible temperature readings.
Previous studies have shown that oesophageal and nasopharyngeal measurements can be taken as an accurate reflection of core temperature [2]. The consistency and accuracy of the other two will be compared to this.
Plan of investigation:
This study will be purely observational. There will be no interference with current practice. Nasopharyngeal/oesophageal probes are routinely placed, according to NICE guidelines, in these patients. The zero-flux thermometer is non-invasive and the ingestible capsule no bigger than a pill, so neither provide any additional risk to the patient.
Temperature readings will be downloaded from each of the three devices with a maximum interval of 1 minute. The investigators have calculated that readings from 15 subjects will provide sufficient power. The investigators plan to recruit 20 patients. Analysis of agreement between the methods will be performed as suggested by Bland and Altman[3].
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zero-flux and ingestible thermometer | – | Device: Zero flux and ingestible thermometersIngestion of a capsule thermometer pre-operatively Attachment of a zero flux temperature electrode intraoperatively Standard oesophageal thermometer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Lacking mental capacity
- Not speaking English
- Malignancy in medical history
- Undergoing open abdominal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zero flux and ingestible thermometers | Device | Zero-flux and ingestible thermometer |
Primary outcome
Comparing the accuracy of zero flux and ingestible thermometers to oesophageal temperature probes.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- Derived from this study: PubMed 30623279Jack 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James M Jack, MBBS BSc principal investigator
BSUH NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Hypothermia, run by Brighton and Sussex University Hospitals NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the accuracy of zero flux and ingestible thermometers to oesophageal temperature probes. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02121574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.