Clinical Evaluation of the Vital Signs Monitoring System (VSMS)

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.

Study Overview

• Status: Unknown
• Conditions: Respiration; Oxygen Saturation; Body Temperature; ECG
• Intervention / Treatment: Device: Vital Signs Monitoring System

Detailed Description

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:

1. Evaluate the body temperature measured by the ear unit and validate its accuracy.
2. Evaluate the accuracy of SPO2 signals and results by comparing the readings to a gold standard device with a finger sensor.

3. 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:

4. 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).
5. 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Israel
  • P.O. Beer Ya'akov, Zerifin, Israel, 70300
    • Recruiting
    • Internal Ward B, Aliza Begin Building, Assaf Harofe Hospital (2nd Floor)
    • Contact: Anat Alon; Phone Number: 972 8-977-9999; Email: alona@asaf.health.gov.il
    • Contact: Peter Spiegel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients of both genders, above 18 years of age, with ASA physical status classified as 1-4. In order to obtain the necessary results, the following shall also define the patient population:

Temperature: 30-50% of subjects shall be febrile, i.e., having:

• An elevated core or rectal temperature of 38.0°C or higher as measured by a clinical thermometer.
• An elevated sublingual temperature of 37.5°C or higher as measured by a clinical thermometer.
• An elevated Axillary temperature of 37.2°C or higher as measured by a clinical thermometer.

SPO2: 10-20% of patients shall have a blood oxygen saturation level of 70-90%.

ECG / Respiration: At least 20% of patients shall have some type of arrhythmia.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: G Medical Innovations Ltd.
• Investigators: Principal Investigator: Moshe Tishler, Professor, Assaf Harofeh Hospital/Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 25, 2017
• Primary Completion (ANTICIPATED): July 31, 2017
• Study Completion (ANTICIPATED): July 31, 2017

Study Registration Dates

• First Submitted: June 15, 2017
• First Submitted That Met QC Criteria: June 29, 2017
• First Posted (ACTUAL): July 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 29, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CLN-7.4.7.10.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No