FeverNCT04182945
Fever Algorithm Development of a Non-invasive Wearable Core Body Temperature Sensor System in Intensive Care Unit Patients
A study testing Data collection for algorithm development in people with Fever, run by greenTEG AG at 1 site in Switzerland.
Trial summary
Background and Rationale: The gold standard to assess fever, is to conduct invasive intravascular, esophageal or bladder thermistor core body temperature (CBT) measurements. Since these methods are time consuming for the medical staff and more importantly displeasing to the patients, alternative CBT/fever assessments… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fever
- What is being tested?
- Data collection for algorithm development
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Dec 2019to 31 Mar 2021
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥18 years old.
- Patients which are treated at the cardiosurgical and vascular intensive care unit of the University Hospital Zurich.
- Expected length of stay in the intensive care unit at least 24 hours
- Clinical standard monitoring including an invasive CBT measurement (e.g. blood temperature from a pulmonary catheter if present or from a vesical catheter routinely placed)
- Informed consent signed by the patient
Who cannot join
- Acute medical contraindications against the measurement of the non-invasive wearable device (e.g. skin diseases) and band-aid allergies.
- Implanted pacemakers or other implanted life sustaining devices
- Comatose state of the patient
- Pregnant Women
Trial locations and contacts
1 site in 1 country.
About this study
Background and Rationale:
The gold standard to assess fever, is to conduct invasive intravascular, esophageal or bladder thermistor core body temperature (CBT) measurements. Since these methods are time consuming for the medical staff and more importantly displeasing to the patients, alternative CBT/fever assessments is needed. greenTEG is developing a CBT algorithm that will be able to reliably calculate CBT continuously form skin temperature (ST) and the corresponding heat flux (HF). This can be achieved from subjects developing fever in intensive care unit, since the prevalence of fever is high and optimally assessed.
Read more
Objective(s):
The aim of this study is to develop and validation of an algorithm that allows the detection of fever in patients through a non-invasive wearable prototype sensor, which calculates CBT from ST, HF and heart rate (HR) data streams, allowing a more effective patient management
Endpoint(s):
ST, HF, HR and CBT data are collected for at least 24hrs until 3 day, depending on the ICU length of stay of the patient. ST, HF, HR and CBT values from different measurement positions (subclavicular, lateral ribcage, upper arm and wrist) of the non-invasive wearable research prototypes will be compared with each other and compared to clinical invasive method particularly CBT measured by blood temperature from a pulmonary catheter if present or vesical temperature
Study Design:
Interventional-Single Group Assignment, monocentric, open label.
Statistical Considerations:
The measure of quality will be the mean absolute difference (MAD) between the CBT prediction and the reference signal where the mean is taken over the whole measurement of a single candidate. An aggregate performance measure over a group of candidates is defined by averaging the MAD values of each candidate in the group. When a group of candidates for algorithm validation is defined, the total improvement will be defined by comparing aggregate performances of old and new algorithm for the validation group. Balancing the probability of occurrence of the factors in the population and the overall size of the study, a final size of 50 candidates is reasonable.
Inclusion- / Exclusion Criteria:
Inclusion criteria:
- Age ≥18 years old.
- Patients which are treated at the cardiosurgical and vascular intensive care unit of the University Hospital Zurich.
- Expected length of stay in the intensive care unit at least 24 hours
- Clinical standard monitoring including an invasive CBT measurement (e.g. blood temperature from a pulmonary catheter if present or from a vesical catheter routinely placed)
- Informed consent signed by the patient
Exclusion criteria:
- Acute medical contraindications against the measurement of the non-invasive wearable device (e.g. skin diseases) and band-aid allergies.
- Implanted pacemakers or other implanted life sustaining devices
- Comatose state of the patient
- Pregnant Women
Number of Participants with Rationale:
Number of participants in the study :50 candidates. The study will be divided in two parts. In the first part data are collected from 38 patients. In the second part, data form 12 patients will be collected. The reason for the first part is to collect data in order to develop the algorithm. The reason to collect additional data from 12 candidates in the second part is to validate and adjust the algorithm that is develop in the first part of the study.
Study Intervention:
50% of the research prototypes (4 pieces) will be mounted to the patient on left side of the body (sub clavicula, lateral ribcage, upper arm and wrist), after being admitted to the ICU and having signed the informed consent. As soon as a patient gets fever, the other 50% of the research prototypes (4 pieces) will be applied on the right side of the body (sub clavicula, lateral ribcage, upper arm and wrist).
Control Intervention:
Not applicable
Study procedures:
Patients will be recruited and screened 1-3 days before the measurements starts. 50% of the research prototypes (4 pieces) will be applied to the patient on the left side of the body (sub clavicula, lateral ribcage, upper arm and wrist), after being admitted to the ICU and having signed the informed consent. After the development of the fever, the other 50% of the research prototypes (4 pieces) will be applied on the right side of the body (sub clavicula, lateral ribcage, upper arm and wrist). At the end of intervention all prototypes will be removed from the patient. A greenTEG employee will collect all the prototypes.
- Conditions
- Fever
- Being tested
- Data collection for algorithm development
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection for algorithm developmentOther
50% of the research prototypes (4 pieces) will be mounted to the patient on left side of the body (sub clavicula, lateral ribcage, upper arm and wrist), after being admitted to the ICU and having signed the informed consent. As soon as a patient gets fever, the other 50% of the research prototypes (4 pieces) will be applied on the right side of the body (sub clavicula, lateral ribcage, upper arm and wrist). Data will be collected unobtrusively (no diagnosis will be made) and used for fever detection algorithm development.
| Study group | Role | What they receive |
|---|---|---|
| Unobtrusive data collection | Other | Unobtrusive data collection using noninvasive sensor systems. Receives: Other: Data collection for algorithm development |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous and non-invasive skin temperature and heat flux
Skin temperature and heat flux data collected continuously and non-invasively using research prototypes at different measurement positions (subclavicular, lateral ribcage, upper arm and wrist).
Measured: Participants will be monitored continuously and unobtrusively with the research prototypes over a 1-3 day time period, depending on the stationary stay in the ICU of the hospital.
Continuous and invasive core body temperature
Core body temperature data will be collected using the clinical standard method, which will be used to monitor patients on the ICU (pulmonary catheter or vesicular temperature).
Measured: Data used will be limited to the time frame, where non-invasive CBT methods are applied (research prototype). This will be 1-3 days, depending on the stationary stay of the patient.
Secondary outcomes (9)
Heart rate
Heart rate [beats per minute] will be collected using the clinical standard method (ECG and pulse oximetry) used to monitor intensive care unit patients, which will be applied anyway (clinical standard procedure).
Measured: Data used will be limited to the time frame, where non-invasive CBT methods are applied (research prototype). This will be 1-3 days, depending on the stationary stay of the patient.
Administration and dose of medication
Administration and dose of medications will be tracked: norepinephrine, epinephrine, adrenaline, vasopressin, Levosimendan, Milrinone, analgesic and antipyretic drugs such as paracetamol.
Measured: Data used will be limited to the time frame, where non-invasive CBT methods are applied (research prototype). This will be 1-3 days, depending on the stationary stay of the patient.
Blood pressure
Blood pressure [mmHg] will be collected using the clinical standard method (Intra-arterial measurements or clinical non-invasive BP monitor) used to monitor intensive care unit patients, which will be applied anyway (clinical standard procedure).
Measured: Data used will be limited to the time frame, where non-invasive methods are applied (research prototype). This will be 1-3 days, depending on the stationary stay of the patient.
ECG
ECG (graphic record of the voltage versus time) will be collected using the clinical standard method, which will be applied anyway (clinical standard procedure)
Measured: Data used will be limited to the time frame, where non-invasive CBT methods are applied (research prototype). This will be 1-3 days, depending on the stationary stay of the patient.
Blood oxygen saturation
Mixed venous oxygen saturation (SvO2) and peripheral capillary oxygen saturation (SpO2) will be collected using the clinical standard method (pulmonary artery catheter for SvO2 and pulse oximetry for SpO2) used to monitor intensive care unit patients, which will be applied anyway (clinical standard procedure).
Measured: Data used will be limited to the time frame, where non-invasive CBT methods are applied (research prototype). This will be 1-3 days, depending on the stationary stay of the patient.
Blood lactate concentration
Blood lactate concentration will be collected using the clinical standard method used to monitor intensive care unit patients, which will be applied anyway (clinical standard procedure).
Measured: Data used will be limited to the time frame, where non-invasive CBT methods are applied (research prototype). This will be 1-3 days, depending on the stationary stay of the patient.
Cardiac Index
Cardiac Index (L/min/m2) will be collected using the clinical standard method (Intra-arterial measurements) used to monitor intensive care unit patients, which will be applied anyway (clinical standard procedure).
Measured: Data used will be limited to the time frame, where non-invasive CBT methods are applied (research prototype). This will be 1-3 days, depending on the stationary stay of the patient.
Fluid balance
Fluid balance will be collected using the clinical standard method used to monitor intensive care unit patients, which will be applied anyway (clinical standard procedure).
Measured: Will be avaluated every 24 hours for every day, where non-invasive CBT methods are applied (research prototype). 1-3 days depending on the stationary stay of the patient.
Central venous pressure
Central venous pressure [mmHg] will be collected using the clinical standard method (central venous catheter) used to monitor intensive care unit patients, which will be applied anyway (clinical standard procedure).
Measured: Data used will be limited to the time frame, where non-invasive CBT methods are applied (research prototype). This will be 1-3 days, depending on the stationary stay of the patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start11 Dec 2019
- Primary completion31 Jan 2021
- Study completion31 Mar 2021
Why it stopped: Not enough patients having fever symptoms
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- greenTEG AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
- Investigators
- Dominique Bettex, Prof. Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182945
- Sponsor's protocol ID
- 6059_Fever_Study_1
- Status last verified
- Aug 2021
- First submitted
- 21 Nov 2019
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The results of this study will be published in a suited journal. Publication strategy is still in discussion.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fever Algorithm Development of a Non-invasive Wearable Core Body Temperature Sensor System in Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT04182945
- Acronym / sponsor ID
- 6059_Fever_Study_1
- Conditions
- Fever
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patients having fever symptoms
- Enrolment
- 20 participants (actual)
- Lead sponsor
- greenTEG AGIndustry (pharma, biotech, devices)
- Collaborators
- University of Zurich
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 2 Dec 2019 (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.
Background and Rationale:
The gold standard to assess fever, is to conduct invasive intravascular, esophageal or bladder thermistor core body temperature (CBT) measurements. Since these methods are time consuming for the medical staff and more importantly displeasing to the patients, alternative CBT/fever assessments is needed. greenTEG is developing a CBT algorithm that will be able to reliably calculate CBT continuously form skin temperature (ST) and the corresponding heat flux (HF). This can be achieved from subjects developing fever in intensive care unit, since the prevalence of fever is high and optimally assessed.
Objective(s):
The aim of this study is to develop and validation of an algorithm that allows the detection of fever in patients through a non-invasive wearable prototype sensor, which calculates CBT from ST, HF and heart rate (HR) data streams, allowing a more effective patient management
Endpoint(s):
ST, HF, HR and CBT data are collected for at least 24hrs until 3 day, depending on the ICU length of stay of the patient. ST, HF, HR and CBT values from different measurement positions (subclavicular, lateral ribcage, upper arm and wrist) of the non-invasive wearable research prototypes will be compared with each other and compared to clinical invasive method particularly CBT measured by blood temperature from a pulmonary catheter if present or vesical temperature
Study Design:
Interventional-Single Group Assignment, monocentric, open label.
Statistical Considerations:
The measure of quality will be the mean absolute difference (MAD) between the CBT prediction and the reference signal where the mean is taken over the whole measurement of a single candidate. An aggregate performance measure over a group of candidates is defined by averaging the MAD values of each candidate in the group. When a group of candidates for algorithm validation is defined, the total improvement will be defined by comparing aggregate performances of old and new algorithm for the validation group. Balancing the probability of occurrence of the factors in the population and the overall size of the study, a final size of 50 candidates is reasonable.
Inclusion- / Exclusion Criteria:
Inclusion criteria:
- Age ≥18 years old.
- Patients which are treated at the cardiosurgical and vascular intensive care unit of the University Hospital Zurich.
- Expected length of stay in the intensive care unit at least 24 hours
- Clinical standard monitoring including an invasive CBT measurement (e.g. blood temperature from a pulmonary catheter if present or from a vesical catheter routinely placed)
- Informed consent signed by the patient
Exclusion criteria:
- Acute medical contraindications against the measurement of the non-invasive wearable device (e.g. skin diseases) and band-aid allergies.
- Implanted pacemakers or other implanted life sustaining devices
- Comatose state of the patient
- Pregnant Women
Number of Participants with Rationale:
Number of participants in the study :50 candidates. The study will be divided in two parts. In the first part data are collected from 38 patients. In the second part, data form 12 patients will be collected. The reason for the first part is to collect data in order to develop the algorithm. The reason to collect additional data from 12 candidates in the second part is to validate and adjust the algorithm that is develop in the first part of the study.
Study Intervention:
50% of the research prototypes (4 pieces) will be mounted to the patient on left side of the body (sub clavicula, lateral ribcage, upper arm and wrist), after being admitted to the ICU and having signed the informed consent. As soon as a patient gets fever, the other 50% of the research prototypes (4 pieces) will be applied on the right side of the body (sub clavicula, lateral ribcage, upper arm and wrist).
Control Intervention:
Not applicable
Study procedures:
Patients will be recruited and screened 1-3 days before the measurements starts. 50% of the research prototypes (4 pieces) will be applied to the patient on the left side of the body (sub clavicula, lateral ribcage, upper arm and wrist), after being admitted to the ICU and having signed the informed consent. After the development of the fever, the other 50% of the research prototypes (4 pieces) will be applied on the right side of the body (sub clavicula, lateral ribcage, upper arm and wrist). At the end of intervention all prototypes will be removed from the patient. A greenTEG employee will collect all the prototypes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unobtrusive data collection | Other | Other: Data collection for algorithm developmentUnobtrusive data collection using noninvasive sensor systems. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years old.
- Patients which are treated at the cardiosurgical and vascular intensive care unit of the University Hospital Zurich.
- Expected length of stay in the intensive care unit at least 24 hours
- Clinical standard monitoring including an invasive CBT measurement (e.g. blood temperature from a pulmonary catheter if present or from a vesical catheter routinely placed)
- Informed consent signed by the patient
Key exclusion criteria (4 listed)
- Acute medical contraindications against the measurement of the non-invasive wearable device (e.g. skin diseases) and band-aid allergies.
- Implanted pacemakers or other implanted life sustaining devices
- Comatose state of the patient
- Pregnant Women
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 |
|---|---|---|
| Data collection for algorithm development50% of the research prototypes (4 pieces) will be mounted to the patient on left side of the body (sub clavicula, lateral ribcage, upper arm and wrist), after being admitted to the ICU and having signed the informed consent. As soon as a patient gets fever, the other 50% of the research prototypes (4 pieces) will be applied on the right side of the body (sub clavicula, lateral ribcage, upper arm and wrist). Data will be collected unobtrusively (no diagnosis will be made) and used for fever detection algorithm development. | Other | Unobtrusive data collection |
Primary outcome
Continuous and non-invasive skin temperature and heat flux
Time frame: Participants will be monitored continuously and unobtrusively with the research prototypes over a 1-3 day time period, depending on the stationary stay in the ICU of the hospital.
Skin temperature and heat flux data collected continuously and non-invasively using research prototypes at different measurement positions (subclavicular, lateral ribcage, upper arm and wrist).
Continuous and invasive core body temperature
Time frame: Data used will be limited to the time frame, where non-invasive CBT methods are applied (research prototype). This will be 1-3 days, depending on the stationary stay of the patient.
Core body temperature data will be collected using the clinical standard method, which will be used to monitor patients on the ICU (pulmonary catheter or vesicular temperature).
9 secondary outcomes
Heart rate
Time frame: Data used will be limited to the time frame, where non-invasive CBT methods are applied (research prototype). This will be 1-3 days, depending on the stationary stay of the patient.
Administration and dose of medication
Time frame: Data used will be limited to the time frame, where non-invasive CBT methods are applied (research prototype). This will be 1-3 days, depending on the stationary stay of the patient.
Blood pressure
Time frame: Data used will be limited to the time frame, where non-invasive methods are applied (research prototype). This will be 1-3 days, depending on the stationary stay of the patient.
ECG
Time frame: Data used will be limited to the time frame, where non-invasive CBT methods are applied (research prototype). This will be 1-3 days, depending on the stationary stay of the patient.
Blood oxygen saturation
Time frame: Data used will be limited to the time frame, where non-invasive CBT methods are applied (research prototype). This will be 1-3 days, depending on the stationary stay of the patient.
Blood lactate concentration
Time frame: Data used will be limited to the time frame, where non-invasive CBT methods are applied (research prototype). This will be 1-3 days, depending on the stationary stay of the patient.
Cardiac Index
Time frame: Data used will be limited to the time frame, where non-invasive CBT methods are applied (research prototype). This will be 1-3 days, depending on the stationary stay of the patient.
Fluid balance
Time frame: Will be avaluated every 24 hours for every day, where non-invasive CBT methods are applied (research prototype). 1-3 days depending on the stationary stay of the patient.
Central venous pressure
Time frame: Data used will be limited to the time frame, where non-invasive CBT methods are applied (research prototype). This will be 1-3 days, depending on the stationary stay of the patient.
Results and safety
The study was stopped early (reason given: Not enough patients having fever symptoms). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Individual participant dataSharing planned: Undecided. The results of this study will be published in a suited journal. Publication strategy is still in discussion.
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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.
Dominique Bettex, Prof. Dr. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data collection for algorithm development in people with Fever, run by greenTEG AG at 1 site in Switzerland.
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 5 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 16 Aug 2021. 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 Switzerland. 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: Not enough patients having fever symptoms). 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?
Continuous and non-invasive skin temperature and heat flux (time frame: Participants will be monitored continuously and unobtrusively with the research prototypes over a 1-3 day time period, depending on the stationary stay in the ICU of the hospital.). The study lists 2 primary outcomes in all. 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 16 Aug 2021.