Clinical Evaluation of the Vital Signs Monitoring System (VSMS)

G Medical Innovations

Status: Unknown

Conditions: Oxygen Saturation; ECG; Respiration; Body Temperature

Treatments: Device: Vital Signs Monitoring System

Study type: Observational

Funder types: Industry

Identifiers

NCT03206528

CLN-7.4.7.10.20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

VSMS with ear unit

Description:

application of Vital Signs Monitoring System with ear unit for 6-10 days during hospitalization (throughout their admission period)

Treatment:

Device: Vital Signs Monitoring System

VSMS without ear unit

Description:

application of Vital Signs Monitoring System without ear unit for 6-10 days during hospitalization (throughout their admission period)

Treatment:

Device: Vital Signs Monitoring System