Transitional Care Study 3

Study Overview
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Brief Summary
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In this study patients with elective surgery will wear two devices (HealthDot and Elan) after surgery in hospital and after discharge at home for up to 2 weeks (HealthDot) or 3 weeks (Elan). The HealthDot will measure heart rate, posture, activity and respiratory rate which are stored on the device as well as sent to Philips. The Elan device will measure PPG and accelerometer data which is transferred to Philips. The data collected will be used for algorithm development. Data will be analysed retrospectively and compared to readmission and adverse events to see if the events could have been predicted due to the collected data by the devices. No clinical decisions will be based on the measurements done during the study.

Official Title
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PJ-013483 FLAGSHIP Transitional Care Study 3

Conditions
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Surgery--Complications

Intervention / Treatment
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* Other: Elan and HealthDot


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Willing and able to sign informed consent form Willingness to abstain from visiting a sauna during the study period Willingness to dry area where the HealthDot is applied in a dipping fashion after washing Willingness to abstain from flying during the study period of time Elective surgery General anesthesia required for surgery Exclusion Criteria: General inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Any skin condition, for example prior rash, discoloration, scars or open wounds at the area of investigation of both devices Pregnant, or breastfeeding Known to be allergic for the tissue adhesive used in the HealthDot. Use of topical that is known to influence the skin at the test area (such as medical and non-medical creams or lotions) Patient with active implantables such as Implantable Cardioverter Defibrilator (ICD) and pacemaker Unable to understand instructions Expected participation less than 2 weeks Left lower rib (place where HealthDot will be applied) is involved in the area of surgery, area of disinfection or area where bandages are needed. Area on arm where the Elan device is applied is involved in the surgical procedure. Patients with antibiotic resitant infections (e.g. MRSA).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elan and HealthDot<br>Patients with elective surgery will wear two devices (HealthDot and Elan) after surgery in hospital and after discharge at home for up to 2 weeks (HealthDot) or 3 weeks (Elan). | Other: Elan and HealthDot<br>* Patients with elective surgery will wear two devices (HealthDot and Elan) after surgery in hospital and after discharge at home for up to 2 weeks (HealthDot) or 3 weeks (Elan).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity | Evaluate the sensitivity and specificity for the prediction of deterioration after surgery using the data from both devices. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy HealthDot | Evaluate if the calculated heart rate and respiratory rate data collected by HealthDot are accurate compared to a gold standard as used in the hospital | 2 weeks | 
| Comfort of wearing measured by questionnaire | Comfort of wearing the HealthDot will be assessed by VAS scale 1-10 while 1 beeing very comfortable, and 10 very uncomfortable | at week 2 | 
| Accuracy Elan | Evaluate if the calculated heart rate and respiratory rate data collected by Elan are accurate compared to a gold standard as used in the hospital | 3 weeks |