Clinical Evaluation of the Vital Signs Monitoring System (VSMS)

NCT03206528 | Unknown FDA Device

• 1 other identifier: CLN-7.4.7.10.20
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Temperature; Oxygen Saturation; Respiration; ECG

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Quality of recorded signal

  after 5-7 days of device usage

Study Arms (2)

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

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

Interventions

Vital Signs Monitoring System DEVICE

The VSMS will be adhered to each enrolled patient for the entire hospitalization period.

VSMS with ear unit; VSMS without ear unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• G Medical Innovations Ltd.: lead

Study Sites (1)

Internal Ward B, Aliza Begin Building, Assaf Harofe Hospital (2nd Floor)

P.O. Beer Ya'akov, Zerifin, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Moshe Tishler, Professor

  Assaf Harofeh Hospital/Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anat Alon

CONTACT

972 8-977-9999; alona@asaf.health.gov.il

Peter Spiegel

CONTACT

psiegel@asaf.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: July 2, 2017
• Study Start: April 25, 2017
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)