Clinical Evaluation of the Vital Signs Monitoring System (VSMS)

Oxygen Saturation Clinical Trial

Official title:

Clinical Evaluation of the Vital Signs Monitoring System (VSMS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03206528
• Other study ID #: CLN-7.4.7.10.20
• Status: Recruiting
• Phase: N/A
• First received: June 15, 2017
• Last updated: June 29, 2017
• Start date: April 25, 2017
• Est. completion date: July 31, 2017

Study information

• Verified date: June 2017
• Source: G Medical Innovations Ltd.
• Contact: Anat Alon
• Phone: 972 8-977-9999
• Email: alona[@]asaf.health.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Temperature
• ECG
• Oxygen Saturation
• Respiration

Intervention

Device:
• Vital Signs Monitoring System
The VSMS will be adhered to each enrolled patient for the entire hospitalization period.

Locations

Country	Name	City	State
Israel	Internal Ward B, Aliza Begin Building, Assaf Harofe Hospital (2nd Floor)	P.O. Beer Ya'akov, Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
G Medical Innovations Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin Temperature measured in units of Celsius/Fahrenheit	Validation of measurement accuracy of skin temperature as compared to gold standard.	6-10 days
Primary	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
Primary	.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	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