Clinical trial NCT03206528: Clinical Evaluation of the Vital Signs Monitoring System (VSMS)
Official title: Clinical Evaluation of the Vital Signs Monitoring System (VSMS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Body Temperature
Oxygen Saturation
Respiration
ECG
Lead sponsor: G Medical Innovations Ltd.
Sponsor class: INDUSTRY
First posted: 2017-07-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Skin Temperature measured in units of Celsius/Fahrenheit
timeFrame: 6-10 days
measure: Oxygen Saturation measured in units of percentage peripheral saturated oxygen
timeFrame: 6-10 days
measure: .ECG signal recording and Respiration measured in units heart beat per minute
timeFrame: 6-10 days
Secondary outcomes:
measure: Quality of recorded signal
timeFrame: after 5-7 days of device usage
Other outcomes:
Locations:
city: P.O. Beer Ya'akov, Zerifin
country: Israel
facility: Internal Ward B, Aliza Begin Building, Assaf Harofe Hospital (2nd Floor)
Study officials:
affiliation: Assaf Harofeh Hospital/Medical Center
name: Moshe Tishler, Professor
role: PRINCIPAL_INVESTIGATOR
References: