Temperature Change, BodyT-CORE-PMCFNCT04489927
Validation of the Measurement Accuracy of the Tcore Thermometer
An observational study of Temperature Change, Body, run by Drägerwerk AG & Co. KGaA at 1 site in Germany.
Trial summary
The aim of the study conducted at the UKSH is to investigate the measuring accuracy of the body core temperature thermometer Tcore®. Therefore the bias of the measurements to the reference measurements of the bladder catheter thermometer is determined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temperature Change, Body
- What is being tested?
- Tcore
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2021to 17 Apr 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients in the ICU of the University Hospital Schleswig-Holstein
Who may be able to join
- Body temperature > 34 °C
- Signed consent
- Bladder catheter with temperature sensor
Who cannot join
- Inflammation of the frontal sinus or the measuring point of the reference measurement (bladder)
- Skin irritation to the adhesive or other materials used
- medication that locally affects the body temperature or the temperature of the reference body site (barbiturates, thyroid preparations, antipsychotics, new vaccines, aspirin, acetaminophen, ibuprofen, or similar)
- Taking antipyretics in the last 120 minutes before measurement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validierung Der Messgenauigkeit Des Tcore Thermometers in Der Anwendung Nicht-invasiver Temperaturmessung gegenüber herkömmlicher Invasiver Messung Auf Der Intensivstation Bei Wachen Patienten
The aim of the study conducted at the UKSH is to investigate the measuring accuracy of the body core temperature thermometer Tcore®. Therefore the bias of the measurements to the reference measurements of the bladder catheter thermometer is determined.
Read the detailed description
The aim of the study conducted at the UKSH is to investigate the measuring accuracy of the body core temperature thermometer Tcore®. Therefore the bias of the measurements to the reference measurements of the bladder catheter thermometer is determined.
Patients included are in the ICU of the UKSH and awake. They already have the reference thermometer in the catheter. The patient investigation time is limited to maximum 2 hours, SAEs will be recorded for 24 hours. The temperature of the two temperature sensors will be compared on three timepoints.
- Conditions
- Temperature Change, Body
- Being tested
- Tcore
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TcoreDevice
Temperature Measurement of standard care versus the Tcore measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature
Temperature measurements with reference thermometer Tcore®
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Oct 2021
- Primary completion11 Apr 2023
- Study completion17 Apr 2023
Why it stopped: Patients couldn't be recruited (no patients with fewer available)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temperature Change, BodyStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drägerwerk AG & Co. KGaA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tobias Graf, Dr., Principal investigator, University Schleswig-Holstein Lübeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489927
- Sponsor's protocol ID
- Tcore-PMCF
- Acronym
- T-CORE-PMCF
- Status last verified
- Aug 2023
- First submitted
- 24 Jul 2020
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validierung Der Messgenauigkeit Des Tcore Thermometers in Der Anwendung Nicht-invasiver Temperaturmessung gegenüber herkömmlicher Invasiver Messung Auf Der Intensivstation Bei Wachen Patienten
- ClinicalTrials.gov ID
- NCT04489927
- Acronym / sponsor ID
- T-CORE-PMCF / Tcore-PMCF
- Conditions
- Temperature Change, Body
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Patients couldn't be recruited (no patients with fewer available)
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Drägerwerk AG & Co. KGaAIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 17 Apr 2023 (actual)
- First posted
- 28 Jul 2020 (actual)
- 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.
The aim of the study conducted at the UKSH is to investigate the measuring accuracy of the body core temperature thermometer Tcore®. Therefore the bias of the measurements to the reference measurements of the bladder catheter thermometer is determined.
Detailed description
The aim of the study conducted at the UKSH is to investigate the measuring accuracy of the body core temperature thermometer Tcore®. Therefore the bias of the measurements to the reference measurements of the bladder catheter thermometer is determined.
Patients included are in the ICU of the UKSH and awake. They already have the reference thermometer in the catheter. The patient investigation time is limited to maximum 2 hours, SAEs will be recorded for 24 hours. The temperature of the two temperature sensors will be compared on three timepoints.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients in the ICU of the University Hospital Schleswig-Holstein
Key inclusion criteria (3 listed)
- Body temperature > 34 °C
- Signed consent
- Bladder catheter with temperature sensor
Key exclusion criteria (4 listed)
- Inflammation of the frontal sinus or the measuring point of the reference measurement (bladder)
- Skin irritation to the adhesive or other materials used
- medication that locally affects the body temperature or the temperature of the reference body site (barbiturates, thyroid preparations, antipsychotics, new vaccines, aspirin, acetaminophen, ibuprofen, or similar)
- Taking antipyretics in the last 120 minutes before measurement
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 |
|---|---|---|
| TcoreTemperature Measurement of standard care versus the Tcore measurement | Device | – |
Primary outcome
Temperature
Time frame: within 24 hours
Temperature measurements with reference thermometer Tcore®
Results and safety
The study was stopped early (reason given: Patients couldn't be recruited (no patients with fewer available)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Tobias Graf, Dr. principal investigator
University Schleswig-Holstein Lübeck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temperature Change, Body, run by Drägerwerk AG & Co. KGaA at 1 site in Germany.
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 3 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: stopped early, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 was stopped early (reason given: Patients couldn't be recruited (no patients with fewer available)). Results are not available in the source record.
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?
Temperature (time frame: within 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2023.