Sepsis Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 8 |
Est. completion date | December 1, 2019 |
Est. primary completion date | November 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Chelsea and Westminster Hospital NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Inova Design Solutions Ltd | Chelsea and Westminster NHS Foundation Trust, Innovate UK |
United Kingdom,
Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10. — View Citation
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. — View Citation
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. — View Citation
Lin LI. A concordance correlation coefficient to evaluate reproducibility. Biometrics. 1989 Mar;45(1):255-68. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Feedback from use of Bodytrak® in post-operative setting | 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. | Final study day (day 2.5) | |
Primary | 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 | |
Primary | 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 | 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. | 2.5 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05095324 -
The Biomarker Prediction Model of Septic Risk in Infected Patients
|
||
Completed |
NCT02714595 -
Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
|
Phase 3 | |
Completed |
NCT03644030 -
Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
|
||
Completed |
NCT02867267 -
The Efficacy and Safety of Ta1 for Sepsis
|
Phase 3 | |
Completed |
NCT04804306 -
Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
|
||
Recruiting |
NCT05578196 -
Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.
|
N/A | |
Terminated |
NCT04117568 -
The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
|
||
Completed |
NCT03550794 -
Thiamine as a Renal Protective Agent in Septic Shock
|
Phase 2 | |
Completed |
NCT04332861 -
Evaluation of Infection in Obstructing Urolithiasis
|
||
Completed |
NCT04227652 -
Control of Fever in Septic Patients
|
N/A | |
Enrolling by invitation |
NCT05052203 -
Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
|
||
Terminated |
NCT03335124 -
The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
|
Phase 4 | |
Recruiting |
NCT04005001 -
Machine Learning Sepsis Alert Notification Using Clinical Data
|
Phase 2 | |
Completed |
NCT03258684 -
Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock
|
N/A | |
Recruiting |
NCT05217836 -
Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
|
||
Completed |
NCT05018546 -
Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery
|
N/A | |
Completed |
NCT03295825 -
Heparin Binding Protein in Early Sepsis Diagnosis
|
N/A | |
Not yet recruiting |
NCT06045130 -
PUFAs in Preterm Infants
|
||
Not yet recruiting |
NCT05361135 -
18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia
|
N/A | |
Not yet recruiting |
NCT05443854 -
Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)
|
Phase 3 |