V-Sensors for Vitals: Assessment of the Accuracy of a Vital Sign Sensor Mounted on a Smartphone

Clinical Accuracy of Vital Sign Pressure Sensor Clinical Trial

Official title:

An Open Label, Interventional, Clinical Performance and Validation Study to Demonstrate the Clinical Accuracy of of the V-Sensor in the Healthy Adult Population; Single Site in Switzerland

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03321851
• Other study ID #: LMD-CT-002
• Status: Not yet recruiting
• Phase: N/A
• First received: October 12, 2017
• Last updated: March 5, 2018
• Start date: April 2018
• Est. completion date: September 2018

Study information

• Verified date: October 2017
• Source: Léman Micro Devices SA
• Contact: Kelly A McClary, RN
• Phone: +41 (0)797764954
• Email: km[@]leman-micro.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial seeks to demonstrate clinical accuracy and safety of the integrated V-Sensor when used by the general, healthy adult population interested in measuring their vital signs outside of the clinical setting.

Description:

The five vital signs are blood pressure, pulse, respiration, SpO2, and temperature. The user tests two devices mounted on two smartphones.

• Temperature: Each user will use the V-sensor mounted on a smartphone to obtain his/her temperature interfaced with a temperature specific 'app'. Before and after the the temperature is obtained using the V-Sensor, the temperature will be obtained using an equivalent thermometer.

• Blood Pressure: Each user will test his/her blood pressure using the two sensors mounted on the two phones interfaced with a blood pressure specific 'app'. Before and after each measurement, a reference measurement using a mercury sphygmomanometer will be taken.

• Pulse, Respiration, SpO2: Each user will test his/her pulse, respiration, and SpO2 using 2 V-sensors mounted on two separate smartphones interfaced with a Pulse, Respiration, and SpO2 'app'. Before and after each measurement, a reference measurement using equivalent reference devices will be taken.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 95
• Est. completion date: September 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Informed Consent

• 18 and 80 years old

• no history or risk for developing lymphedema

• no arteriovenous fistula in the right arm

• no right limb amputation up to and including the right index finger

• ability to obtain 3 readings from the device during the screening/training session.

Exclusion Criteria:

• history of arrhythmia

• arteriovenous fistula in the right arm

• lymphedema or high risk for developing lymphedema in the right arm

• inability to follow the procedures of the study

• inability to hold the study device as instructed

• inability to obtain 3 readings from the study device during the screening session

• previous enrolment into the current study

• enrolment of the Investigator or Sponsor, his/her family members, employees and other dependent persons.

Related Conditions & MeSH terms

• Clinical Accuracy of Vital Sign Pressure Sensor

Intervention

Device:
• V-sensor device user
Participants use device to detect the 5 vital signs (Blood Pressure, Pulse, Respiration, SpO2, Temperature).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Léman Micro Devices SA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure accuracy to the reference device within the ranges specified by the ISO standard 81060-2	For systolic and diastolic blood pressures, the mean error of determination of the individual paired determinations of the sphygmomanometer-under-test and the reference sphygmomanometer (Standby Baumanometer) for all participants shall not be greater than 8.0mmHg.	4 months
Primary	Pulse Rate accuracy to the reference device within the ranges specified by the ISO 80601-2-61	Pulse rate accuracy shall be stated as the root-mean-square (rms) difference between paired pulse rate data recorded with the pulse oximeter equipment and with the Nellcor N-PA reference device.	4 months
Primary	Blood Oxygen accuracy to the reference device within the ranges specified by the ISO 80601-2-61.	The SpO2 accuracy shall be stated as a root-mean-square (rms) difference of less than or equal to 4.0% SpO2 over the range of 70% to 100% SaO2	4 months
Primary	Respiration rate accuracy	Respiration rate accuracy shall be stated as the root-mean-square (rms) difference between paired respiratory rate data with the Passport Respiration Rate Sensor PS-2133 reference method; target range +/- 10% of participant's respiratory rate	4 months
Primary	Temperature accuracy to the reference device with the ranges specified by the ISO 80601-2-56 & ATSM 1965 Standard.	Temperature accuracy shall be stated as the root-mean-square (rms) difference between paired temperatures data recorded with the Exergen Temporal Scanner thermometer. LMD's target is a clinical bias <= 3.0°C and a clinical repeatability <= 3.0°C.	4 months
Secondary	No serious adverse device effects are reported.	Zero serious adverse device effects are reported.	4 months