Monitoring, PhysiologicNCT03139955
Bodytrak® Feasibility Study
An observational study of Monitoring, Physiologic and Vital Signs, run by Inova Design Solutions Ltd at 1 site in United Kingdom.
Trial summary
Bodytrak® is a wireless earpiece which can monitor the user's vital signs such as tympanic (ear) temperature and heart rate. The earpiece is non-invasive and should fit comfortably within the right ear, similar to an earphone with an over-the-ear hook. Bodytrak is currently in a prototype stage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Monitoring, Physiologic, Vital Signs, Sepsis
- What is being tested?
- Bodytrak
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2019to 1 Dec 2019
- How long will I take part?
- 3 Days
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pre and post operative in-patients undergoing minor surgery and admitted for aftercare in the high dependency unit.
Who may be able to join
- In order to be able to participate in this study, an individual must meet all of the following criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female.
- Age of ≥ 18 years at screening.
- BMI between ≥19.0 and ≤30.0, inclusive.
Show all 9Show fewer
- An in-patient hospital stay in the high dependency unit of at least 2 days following elective general surgery at Chelsea and Westminster Hospital.
- American Society of Anaesthesiologist (ASA) Physical status classification System 1-2
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Who cannot join
- The participant may not enter the study if ANY of the following apply:
- Presence of a cardiac pacemaker.
- Current or history of clinically significant cardiovascular disease, condition or abnormality including coronary artery disease, myocardial infarction, abnormal heart rhythms or arrhythmias, heart failure, heart valve disease, congenital heart disease, cardiomyopathy as determined by the physical exam or medical history review.
- Use of the following cardiac drugs: beta blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers/inhibitors or digitalis preparations within 3 months of Screening.
- Current infection or condition of the right ear as determined by the Right Ear Exam or documented in medical history questionnaire, which may be exacerbated by the use of Bodytrak in the opinion of the investigator.
- Patients who are on the ventilator and are persistently unconscious throughout their stay in the HDU.
Show all 16Show fewer
- Hypersensitivity or allergy to any of the Bodytrak materials that are in contact with the skin - SLA, PLA (3D printer resins), black Pro Flex 50 (Rubber), clear vacuum cast 40/55 shore silicone, and black anodised aluminium.
- Patient known to have resistant organisms including Vancomycin-Resistant Enterococcus (VRE), Extended-Spectrum Beta-Lactamase (ESBL) \& Methicillin-Resistant Staphylococcus aureus (MRSA), meaning Bodytrak would be unable to be cleaned using the approved cleaning protocol.
- Any hearing impediment that, in the opinion of the investigator, would not be compatible with the use of Bodytrak.
- Bodytrak not compatible to fit securely and correctly in the patient's right ear.
- Participant unwilling to wear Bodytrak for the durations stated in the study protocol due to comfort and/or preference issues.
- Pain reported during Right Ear Pain Assessment at screening
- Currently participating in another clinical trial with an investigational or non-investigational drug or device, or has participated in another clinical trial within 3 months preceding Day 1.
- Any condition that, in the opinion of the investigator, compromises the participant's ability to meet protocol requirements or to complete the study.
- Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
- Patient refusal
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH
Marcela Vizcaychipi, Dr, +44 (0)20 3315 8024, Marcela.Vizcaychipi@chelwest.nhs.uk
Ahmed Al-Hindawi, Dr, 07875356668, ahmed.al-hindawi@nhs.net
About this study
Official title: A Single Group, Non-randomised, Feasibility Study Investigating the Use of Bodytrak® for Post Elective Surgery Patient Monitoring in the High Dependency Unit
Bodytrak® is a wireless earpiece which can monitor the user's vital signs such as tympanic (ear) temperature and heart rate. The earpiece is non-invasive and should fit comfortably within the right ear, similar to an earphone with an over-the-ear hook. Bodytrak is currently in a prototype stage.
The purpose of this study is to assess the feasibility of conducting a trial investigating the integration of Bodytrak in an NHS (National Health Service) environment at Chelsea and Westminster Hospital; to collect patient vital sign data for the development of Bodytrak algorithms to detect the transition point of recovery/deterioration of health, as well as the level of consciousness; and to obtain nurse and patient feedback regarding their user experience of Bodytrak.
Read the detailed description
BACKGROUND Sepsis claims many lives annually, and poses a substantial drain on NHS (National Health System) resources. The use of a 'track-and-trigger' monitoring system, or the National Early Warning System (NEWS) has reduced mortality rates in recent years, by detecting the early onset of Sepsis. However, the acquisition of vital signs, required as part of NEWS, is a manual, error-prone, and time consuming process. Therefore, scope exists for improvement in the care pathway by automation and subsequent improvements in reliability, staff productivity, and patient treatment outcomes.
Post-operative patients are typically monitored for a period of time before they are discharged. Potentially, patient safety can be further improved, and earlier discharge can be enabled by means of a continuous vital signs monitoring device, with algorithms that can track deterioration/recovery rate. This complementary information, together with the NEWS score, can then provide objective metrics to aid the attending physician. The primary objectives of this study are to assess the effectiveness of Bodytrak in monitoring patient health.
In addition, within the set of vital signs monitored by NEWS, it is most difficult to automate the measurement of the Level of Consciousness/Alertness (LOC). Therefore, one objective of the proposed project is to investigate the feasibility of developing an unobtrusive method for automatically measuring LOC, of patients who are not under the influence of general anesthesia, which leads to the introduction of Bodytrak. Bodytrak® is a non-invasive, wireless ear-based device which can continuously monitor physiological parameters including tympanic temperature, photoplethysmography (PPG) derived heart rate and heart rate variability and accelerometer based motion metrics. The earpiece should fit comfortably within the right ear, similar to a earphone.
To this end, the physiological and biomechanical signals required for LOC algorithm development will be acquired using Bodytrak®. Automating the measurements of two other vital signs - Tympanic temperature and heart rate, will be carried out using Bodytrak® as well. Since these vitals are important predictors of Sepsis, and because they are currently part of the NEWS framework, providing reliable means of measurement, and automating the acquisition process is consistent with the goal of improving patient safety and staff productivity. As an important part of the study, these primary vital signs will be evaluated against validated medical devices.
Further, critical to eventual improvement of the care pathway by means of Bodytrak® is the feedback that can be gathered from both patients and clinical staff, since they are the end users of the system. If this application is approved, Inova intends to work closely with its partner, Chelsea and Westminster Hospital, in order to gather information necessary for the integration of Bodytrak® into the NEWS framework.
TRIAL DESIGN The trial is a non-blind, non-randomised single group feasibility study. 8 participants will be recruited who have scheduled elective surgery and aftercare in the HDU (high dependency unit). Patient participation will include 2 visits: a screening visit during a pre-clinic visit; and an intervention visit which will last approximately 2.5 days during their elective surgery in-patient stay in the high dependency unit. During their in-patient stay, participants will wear a Bodytrak earpiece during the day (for approximately 8 hours per day during the working hours of the research nurse), alongside continuous vital sign monitoring from hospital standard equipment (Philips Intellivue MP50 Monitor). The research nurse will carry out hourly checks on the patient to ensure the earpiece is not causing any discomfort. Patients will be asked to complete a feedback questionnaire regarding their experience of wearing Bodytrak. Research nurse's will also complete a feedback questionnaire regarding their use of Bodytrak.
While the sample size is admittedly small, note that the purpose of this study is NOT to validate Bodytrak® as a medical device, but rather to determine if it is feasible to devise reliable algorithms for reliably detecting the LOC and patient status, as well as to carry out a preliminary evaluation of the vital signs derived from Bodytrak®. A power analysis test will be carried out after the data collection has completed, in order to ascertain the validity of the statistical tests used and to determine if the sample size is sufficiently large. This would provide useful information for further studies that need to be carried out.
- Being tested
- Bodytrak
- Keywords
- Feasibility Study, Pre/Post-Operative Patient Monitoring, Continuous Patient Monitoring, Patient Deterioration Identification, Bodytrak, National Early Warning System, Patient Safety
- Medical subject headings
- Sepsis, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BodytrakDevice
Bodytrak is a wireless earpiece which can monitor the user's vital signs such as tympanic (ear) temperature and heart rate. The earpiece is non-invasive and should fit comfortably within the right ear, similar to an earphone with an over-the-ear hook. Bodytrak is currently in a prototype stage. For further information please visit http://www.bodytrak.co
| Study group | Role | What they receive |
|---|---|---|
| Bodytrak | This is a single group study. 8 participants will be recruited and will receive the same intervention of physiological data collection using Bodytrak. Receives: Device: Bodytrak |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Bodytrak tympanic temperature data compared to gold standard hospital monitoring equipment
Establish if there are in-situ statistical and clinical significant differences between Bodytrak tympanic temperature and gold reference equipment used as part of standard care (tympanic thermometer). The extent of these differences will be measured using statistical tools such as 95% prediction interval, Bland-Altman plots, and correlation coefficients.
Measured: 2.5 days
Accuracy of Bodytrak heart rate data compared to gold standard hospital monitoring equipment
Establish if there are in-situ statistical and clinical significant differences between Bodytrak heart rate and gold reference equipment used as part of standard care (3-lead ECG). The extent of these differences will be measured using statistical tools such as 95% prediction interval, Bland-Altman plots, and correlation coefficients.
Measured: 2.5 days
Secondary outcomes (1)
Level of alertness/consciousness (LOC) algorithm.
The efficacy of the LOC algorithm, as compared to the RASS consciousness scale will be measured using positive predictivity, sensitivity, and classification accuracy.
Measured: 2.5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start1 Aug 2019 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Monitoring, PhysiologicStudies 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
- 8 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Inova Design Solutions Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chelsea and Westminster NHS Foundation Trust, Innovate UK
- Responsible party
- Sponsor
- Investigators
- Marcela Vizcaychipi, Dr, Principal investigator, Chelsea and Westminster NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139955
- Sponsor's protocol ID
- BT01
- Status last verified
- Apr 2019
- First submitted
- 21 Apr 2017
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghasemi A, Zahediasl S. Normality tests for statistical analysis: a guide for non-statisticians. Int J Endocrinol Metab. 2012 Spring;10(2):486-9. doi: 10.5812/ijem.3505. Epub 2012 Apr 20.
PubMed 23843808Lin LI. A concordance correlation coefficient to evaluate reproducibility. Biometrics. 1989 Mar;45(1):255-68.
PubMed 2720055Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
PubMed 2868172Gregoski MJ, Mueller M, Vertegel A, Shaporev A, Jackson BB, Frenzel RM, Sprehn SM, Treiber FA. Development and validation of a smartphone heart rate acquisition application for health promotion and wellness telehealth applications. Int J Telemed Appl. 2012;2012:696324. doi: 10.1155/2012/696324. Epub 2012 Jan 5.
PubMed 22272197Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
PubMed 12421743McNarry AF, Goldhill DR. Simple bedside assessment of level of consciousness: comparison of two simple assessment scales with the Glasgow Coma scale. Anaesthesia. 2004 Jan;59(1):34-7. doi: 10.1111/j.1365-2044.2004.03526.x.
PubMed 14687096
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Group, Non-randomised, Feasibility Study Investigating the Use of Bodytrak® for Post Elective Surgery Patient Monitoring in the High Dependency Unit
- ClinicalTrials.gov ID
- NCT03139955
- Acronym / sponsor ID
- BT01
- Keywords
- Feasibility Study, Pre/Post-Operative Patient Monitoring, Continuous Patient Monitoring, Patient Deterioration Identification, Bodytrak, National Early Warning System, Patient Safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Inova Design Solutions LtdIndustry (pharma, biotech, devices)
- Collaborators
- Chelsea and Westminster NHS Foundation Trust, Innovate UK
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 4 May 2017 (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.
Bodytrak® is a wireless earpiece which can monitor the user's vital signs such as tympanic (ear) temperature and heart rate. The earpiece is non-invasive and should fit comfortably within the right ear, similar to an earphone with an over-the-ear hook. Bodytrak is currently in a prototype stage.
The purpose of this study is to assess the feasibility of conducting a trial investigating the integration of Bodytrak in an NHS (National Health Service) environment at Chelsea and Westminster Hospital; to collect patient vital sign data for the development of Bodytrak algorithms to detect the transition point of recovery/deterioration of health, as well as the level of consciousness; and to obtain nurse and patient feedback regarding their user experience of Bodytrak.
Detailed description
BACKGROUND Sepsis claims many lives annually, and poses a substantial drain on NHS (National Health System) resources. The use of a 'track-and-trigger' monitoring system, or the National Early Warning System (NEWS) has reduced mortality rates in recent years, by detecting the early onset of Sepsis. However, the acquisition of vital signs, required as part of NEWS, is a manual, error-prone, and time consuming process. Therefore, scope exists for improvement in the care pathway by automation and subsequent improvements in reliability, staff productivity, and patient treatment outcomes.
Post-operative patients are typically monitored for a period of time before they are discharged. Potentially, patient safety can be further improved, and earlier discharge can be enabled by means of a continuous vital signs monitoring device, with algorithms that can track deterioration/recovery rate. This complementary information, together with the NEWS score, can then provide objective metrics to aid the attending physician. The primary objectives of this study are to assess the effectiveness of Bodytrak in monitoring patient health.
In addition, within the set of vital signs monitored by NEWS, it is most difficult to automate the measurement of the Level of Consciousness/Alertness (LOC). Therefore, one objective of the proposed project is to investigate the feasibility of developing an unobtrusive method for automatically measuring LOC, of patients who are not under the influence of general anesthesia, which leads to the introduction of Bodytrak. Bodytrak® is a non-invasive, wireless ear-based device which can continuously monitor physiological parameters including tympanic temperature, photoplethysmography (PPG) derived heart rate and heart rate variability and accelerometer based motion metrics. The earpiece should fit comfortably within the right ear, similar to a earphone.
To this end, the physiological and biomechanical signals required for LOC algorithm development will be acquired using Bodytrak®. Automating the measurements of two other vital signs - Tympanic temperature and heart rate, will be carried out using Bodytrak® as well. Since these vitals are important predictors of Sepsis, and because they are currently part of the NEWS framework, providing reliable means of measurement, and automating the acquisition process is consistent with the goal of improving patient safety and staff productivity. As an important part of the study, these primary vital signs will be evaluated against validated medical devices.
Further, critical to eventual improvement of the care pathway by means of Bodytrak® is the feedback that can be gathered from both patients and clinical staff, since they are the end users of the system. If this application is approved, Inova intends to work closely with its partner, Chelsea and Westminster Hospital, in order to gather information necessary for the integration of Bodytrak® into the NEWS framework.
TRIAL DESIGN The trial is a non-blind, non-randomised single group feasibility study. 8 participants will be recruited who have scheduled elective surgery and aftercare in the HDU (high dependency unit). Patient participation will include 2 visits: a screening visit during a pre-clinic visit; and an intervention visit which will last approximately 2.5 days during their elective surgery in-patient stay in the high dependency unit. During their in-patient stay, participants will wear a Bodytrak earpiece during the day (for approximately 8 hours per day during the working hours of the research nurse), alongside continuous vital sign monitoring from hospital standard equipment (Philips Intellivue MP50 Monitor). The research nurse will carry out hourly checks on the patient to ensure the earpiece is not causing any discomfort. Patients will be asked to complete a feedback questionnaire regarding their experience of wearing Bodytrak. Research nurse's will also complete a feedback questionnaire regarding their use of Bodytrak.
While the sample size is admittedly small, note that the purpose of this study is NOT to validate Bodytrak® as a medical device, but rather to determine if it is feasible to devise reliable algorithms for reliably detecting the LOC and patient status, as well as to carry out a preliminary evaluation of the vital signs derived from Bodytrak®. A power analysis test will be carried out after the data collection has completed, in order to ascertain the validity of the statistical tests used and to determine if the sample size is sufficiently large. This would provide useful information for further studies that need to be carried out.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bodytrak | – | Device: BodytrakThis is a single group study. 8 participants will be recruited and will receive the same intervention of physiological data collection using Bodytrak. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pre and post operative in-patients undergoing minor surgery and admitted for aftercare in the high dependency unit.
Key inclusion criteria (9 listed)
- In order to be able to participate in this study, an individual must meet all of the following criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female.
- Age of ≥ 18 years at screening.
Key exclusion criteria (16 listed)
- Presence of a cardiac pacemaker.
- Current or history of clinically significant cardiovascular disease, condition or abnormality including coronary artery disease, myocardial infarction, abnormal heart rhythms or arrhythmias, heart failure, heart valve disease, congenital heart disease, cardiomyopathy as determined by the physical exam or medical history review.
- Use of the following cardiac drugs: beta blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers/inhibitors or digitalis preparations within 3 months of Screening.
- Current infection or condition of the right ear as determined by the Right Ear Exam or documented in medical history questionnaire, which may be exacerbated by the use of Bodytrak in the opinion of the investigator.
- Patients who are on the ventilator and are persistently unconscious throughout their stay in the HDU.
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 |
|---|---|---|
| BodytrakBodytrak is a wireless earpiece which can monitor the user's vital signs such as tympanic (ear) temperature and heart rate. The earpiece is non-invasive and should fit comfortably within the right ear, similar to an earphone with an over-the-ear hook. Bodytrak is currently in a prototype stage. For further information please visit http://www.bodytrak.co | Device | Bodytrak |
Primary outcome
Accuracy of Bodytrak tympanic temperature data compared to gold standard hospital monitoring equipment
Time frame: 2.5 days
Establish if there are in-situ statistical and clinical significant differences between Bodytrak tympanic temperature and gold reference equipment used as part of standard care (tympanic thermometer). The extent of these differences will be measured using statistical tools such as 95% prediction interval, Bland-Altman plots, and correlation coefficients.
Accuracy of Bodytrak heart rate data compared to gold standard hospital monitoring equipment
Time frame: 2.5 days
Establish if there are in-situ statistical and clinical significant differences between Bodytrak heart rate and gold reference equipment used as part of standard care (3-lead ECG). The extent of these differences will be measured using statistical tools such as 95% prediction interval, Bland-Altman plots, and correlation coefficients.
1 secondary outcome
Level of alertness/consciousness (LOC) algorithm.
Time frame: 2.5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Background: PubMed 23843808Ghasemi A, Zahediasl S. Normality tests for statistical analysis: a guide for non-statisticians. Int J Endocrinol Metab. 2012 Spring;10(2):486-9. doi: 10.5812/ijem.3505. Epub 2012 Apr 20.
- Background: PubMed 2720055Lin LI. A concordance correlation coefficient to evaluate reproducibility. Biometrics. 1989 Mar;45(1):255-68.
- Background: PubMed 2868172Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
- Background: PubMed 22272197Gregoski MJ, Mueller M, Vertegel A, Shaporev A, Jackson BB, Frenzel RM, Sprehn SM, Treiber FA. Development and validation of a smartphone heart rate acquisition application for health promotion and wellness telehealth applications. Int J Telemed Appl. 2012;2012:696324. doi: 10.1155/2012/696324. Epub 2012 Jan 5.
- Background: PubMed 12421743Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
- Background: PubMed 14687096McNarry AF, Goldhill DR. Simple bedside assessment of level of consciousness: comparison of two simple assessment scales with the Glasgow Coma scale. Anaesthesia. 2004 Jan;59(1):34-7. doi: 10.1111/j.1365-2044.2004.03526.x.
- Further information regarding BodytrakLink provided by the sponsor.
- J. Morrison, "Accessed 24 March 2017, Minimizing Bias in Experimental Design and ExecutionLink provided by the sponsor.
- 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.
Marcela Vizcaychipi, Dr principal investigator
Chelsea and Westminster NHS Foundation Trust
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 Monitoring, Physiologic and Vital Signs, run by Inova Design Solutions Ltd at 1 site 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 9 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 19 Apr 2019. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcela Vizcaychipi, Dr (+44 (0)20 3315 8024, Marcela.Vizcaychipi@chelwest.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Bodytrak tympanic temperature data compared to gold standard hospital monitoring equipment (time frame: 2.5 days). 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?
On the ClinicalTrials.gov record for NCT03139955, which also lists 6 linked publications.
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 19 Apr 2019.