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Bodytrak® Feasibility Study

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ClinicalTrials.gov Identifier: NCT03139955
Recruitment Status : Not yet recruiting
First Posted : May 4, 2017
Last Update Posted : January 5, 2018
Sponsor:
Collaborators:
Chelsea and Westminster NHS Foundation Trust
Innovate UK
Information provided by (Responsible Party):
Inova Design Solutions Ltd

Brief 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.

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.


Condition or disease Intervention/treatment
Monitoring, Physiologic Vital Signs Sepsis Altered Level of Consciousness Device: Bodytrak

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Days
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
Estimated Study Start Date : February 20, 2018
Estimated Primary Completion Date : April 20, 2018
Estimated Study Completion Date : April 20, 2018

Group/Cohort Intervention/treatment
Bodytrak
This is a single group study. 8 participants will be recruited and will receive the same intervention of physiological data collection using Bodytrak.
Device: Bodytrak
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Level of alertness/consciousness (LOC) algorithm. [ Time Frame: 2.5 days ]
    The efficacy of the LOC algorithm, as compared to the RASS consciousness scale will be measured using positive predictivity, sensitivity, and classification accuracy.


Other Outcome Measures:
  1. Feedback from use of Bodytrak® in post-operative setting [ Time Frame: Final study day (day 2.5) ]
    Questionnaires will be filled out by clinical staff operating the device, and patients who will be wearing it, in order to assess the usability of the device and find out desired features in the clinical setting.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pre and post operative in-patients undergoing minor surgery and admitted for aftercare in the high dependency unit.
Criteria

Inclusion Criteria

In order to be able to participate in this study, an individual must meet all of the following criteria:

  1. Participant is willing and able to give informed consent for participation in the study.
  2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. Male or female.
  4. Age of ≥ 18 years at screening.
  5. BMI between ≥19.0 and ≤30.0, inclusive.
  6. An in-patient hospital stay in the high dependency unit of at least 2 days following elective general surgery at Chelsea and Westminster Hospital.
  7. American Society of Anaesthesiologist (ASA) Physical status classification System 1-2
  8. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion Criteria

The participant may not enter the study if ANY of the following apply:

  1. Presence of a cardiac pacemaker.
  2. 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.
  3. 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.
  4. 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.
  5. Patients who are on the ventilator and are persistently unconscious throughout their stay in the HDU.
  6. 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.
  7. 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.
  8. Any hearing impediment that, in the opinion of the investigator, would not be compatible with the use of Bodytrak.
  9. Bodytrak not compatible to fit securely and correctly in the patient's right ear.
  10. Participant unwilling to wear Bodytrak for the durations stated in the study protocol due to comfort and/or preference issues.
  11. Pain reported during Right Ear Pain Assessment at screening
  12. 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.
  13. Any condition that, in the opinion of the investigator, compromises the participant's ability to meet protocol requirements or to complete the study.
  14. Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
  15. Patient refusal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03139955


Contacts
Contact: Marcela Vizcaychipi, Dr +44 (0)20 3315 8024 Marcela.Vizcaychipi@chelwest.nhs.uk
Contact: Ahmed Al-Hindawi, Dr 078753566668 ahmed.al-hindawi@nhs.net

Locations
United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust Not yet recruiting
London, United Kingdom, SW10 9NH
Contact: Marcela Vizcaychipi, Dr    +44 (0)20 3315 8024    Marcela.Vizcaychipi@chelwest.nhs.uk   
Contact: Ahmed Al-Hindawi, Dr    07875356668    ahmed.al-hindawi@nhs.net   
Sponsors and Collaborators
Inova Design Solutions Ltd
Chelsea and Westminster NHS Foundation Trust
Innovate UK
Investigators
Principal Investigator: Marcela Vizcaychipi, Dr Chelsea and Westminster Hospital NHS Foundation Trust

Additional Information:
Publications:
Responsible Party: Inova Design Solutions Ltd
ClinicalTrials.gov Identifier: NCT03139955     History of Changes
Other Study ID Numbers: BT01
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Inova Design Solutions Ltd:
Feasibility Study
Pre/Post-Operative Patient Monitoring
Continuous Patient Monitoring
Patient Deterioration Identification
Bodytrak
National Early Warning System
Patient Safety

Additional relevant MeSH terms:
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders