Bodytrak® Feasibility Study

NCT03139955 | Unknown

• 1 other identifier: BT01
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Monitoring, Physiologic; Vital Signs; Sepsis; Altered Level of Consciousness

Keywords

Feasibility Study; Pre/Post-Operative Patient Monitoring; Continuous Patient Monitoring; Patient Deterioration Identification; Bodytrak; National Early Warning System; Patient Safety

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2.5 days

Secondary Outcomes (1)

• Level of alertness/consciousness (LOC) algorithm.

  2.5 days

Other Outcomes (1)

• Feedback from use of Bodytrak® in post-operative setting

  Final study day (day 2.5)

Study Arms (1)

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

Interventions

Bodytrak DEVICE

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

Bodytrak

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Inova Design Solutions Ltd: lead
• Chelsea and Westminster NHS Foundation Trust: collaborator
• Innovate UK: collaborator

Study Sites (1)

Chelsea and Westminster Hospital NHS Foundation Trust

London, SW10 9NH, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 23843808 BACKGROUND

• Lin LI. A concordance correlation coefficient to evaluate reproducibility. Biometrics. 1989 Mar;45(1):255-68.

  PMID: 2720055 BACKGROUND

• Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.

  PMID: 2868172 BACKGROUND

• Gregoski 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.

  PMID: 22272197 BACKGROUND

• Sessler 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.

  PMID: 12421743 BACKGROUND

• McNarry 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.

  PMID: 14687096 BACKGROUND

Related Links

• Further information regarding Bodytrak
• J. Morrison, "Accessed 24 March 2017, Minimizing Bias in Experimental Design and Execution

MeSH Terms

Conditions

Sepsis; Consciousness Disorders

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Marcela Vizcaychipi, Dr

  Chelsea and Westminster NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcela Vizcaychipi, Dr

CONTACT

+44 (0)20 3315 8024; Marcela.Vizcaychipi@chelwest.nhs.uk

Ahmed Al-Hindawi, Dr

CONTACT

078753566668; ahmed.al-hindawi@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: May 4, 2017
• Study Start: August 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 19, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)