Clinical Evaluation of the Vital Signs Monitoring System (VSMS)

Study Overview
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Brief Summary
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This is an observational, cohort-based, single-site, prospective study conducted in accordance with ISO 14155-1:2003 and ISO 14155-1:2011. The primary objectives are to evaluate the accuracy of the device's measurements/readings in comparison to a gold standard or standard of care patient monitor.

Detailed Description
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This is an observational, cohort-based, single-site, prospective clinical study enrolling up to 100 patients who are hospitalized in the internal ward. There is no control group. The primary objectives of the study are: Evaluate the body temperature measured by the ear unit and validate its accuracy. Evaluate the accuracy of SPO2 signals and results by comparing the readings to a gold standard device with a finger sensor. Evaluate the ECG and respiration signals recorded by the patch device by comparing them to the signals recorded by a patient monitor with standard leads. The secondary objectives of the study are: Usability - evaluate the ease of use of the device by medical staff and patients (e.g., positioning, activation, replacement of patch, understanding processes and requirements). Evaluate the signals quality and the patch adherence after 5 - 7 days on the chest. The study will assess the safety and effectiveness of the Vital Signs Monitoring System (VSMS) for its intended use/proposed indications. Data will be collected while the VSMS is adhered to each patient for the entire hospitalization period, up to 7 days. There is no follow-up required.

Official Title
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Clinical Evaluation of the Vital Signs Monitoring System (VSMS)

Conditions
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ECG, Body Temperature, Oxygen Saturation, Respiration

Intervention / Treatment
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* Device: Vital Signs Monitoring System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent Age above 18 years from both genders American Society of Anesthesiologists (ASA) physical status classification of 1-4 Hospitalized in internal ward Exclusion Criteria: Abuse of alcohol or illicit drugs History of mental retardation or any mental disease Skin irritation / Atopic dermatitis or any other skin condition in the area of patient's upper chest that might affect his/her ability to adhere the device appropriately

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VSMS with ear unit<br>application of Vital Signs Monitoring System with ear unit for 6-10 days during hospitalization (throughout their admission period) | Device: Vital Signs Monitoring System<br>* The VSMS will be adhered to each enrolled patient for the entire hospitalization period.<br>|
| VSMS without ear unit<br>application of Vital Signs Monitoring System without ear unit for 6-10 days during hospitalization (throughout their admission period) | Device: Vital Signs Monitoring System<br>* The VSMS will be adhered to each enrolled patient for the entire hospitalization period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Temperature measured in units of Celsius/Fahrenheit | Validation of measurement accuracy of skin temperature as compared to gold standard. | 6-10 days | 
| Oxygen Saturation measured in units of percentage peripheral saturated oxygen | Validation of measurement accuracy of peripheral oxygen saturation as compared to gold standard. | 6-10 days | 
| .ECG signal recording and Respiration measured in units heart beat per minute | Assess quality of device's recorded ECG and respiration signals as compared to patient monitor with standard leads | 6-10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of recorded signal | Evaluate the quality of recorded signals in time by comparing signal of day 1 with signal in last day of adherence of the patch | after 5-7 days of device usage |