Ignite Creation Date:
2024-05-06 @ 1:59 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04182945
Status:
TERMINATED
Last Update Posted:
2021-08-16
First Post:
2019-11-21
Brief Title:
Fever Algorithm Development of a Non-invasive Wearable Core Body Temperature Sensor System in Intensive Care Unit Patients
Sponsor:
greenTEG AG
Organization:
greenTEG AG
Study Overview
Official Title:
Fever Algorithm Development of a Non-invasive Wearable Core Body Temperature Sensor System in Intensive Care Unit Patients
Status:
TERMINATED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not enough patients having fever symptoms
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 CBTfever 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
Objectives
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
Endpoints
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 eg 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 eg 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
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 CBTfever 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
Objectives
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
Endpoints
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 eg 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 eg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None