Validation of Lifelight First - a non-contact vital signs monitor
Research type
Research Study
Full title
A SINGLE-CENTRE STUDY TO DEMONSTRATE THE SAFETY AND PERFORMANCE OF LIFELIGHT® FIRST SOFTWARE APPLICATION - A NON-INVASIVE VITAL SIGNS MONITORING DEVICE
IRAS ID
258187
Contact name
Mitch Lomax
Contact email
Sponsor organisation
xim Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
Assessing the performance of Lifelight® First in the measurement of vital signs (pulse, blood pressure, respiration rate and oxygen saturation).
This research is being conducted to validate the performance of a medical device that is undergoing CE marking so it can be sold throughout the European Union. The results of the device will be compared to another device that is already approved for medical use.
Measurement of vital signs is an essential part of any clinical assessment and is undertaken regularly on patients accessing healthcare services. The accuracy of these measurements is of vital importance as decisions regarding the urgency of medical review and subsequent management are often influenced by these measures.
Lifelight® First is software which allows non-invasive, non-contact measurement of these observations. It can be used on a tablet (e.g. Apple® iPad®) that possesses an integral camera. Lifelight® First has potential application within various areas of the health care system and could also be used in settings where direct access to health care is limited or as a part of a telemedicine service.
A minimum of 85 adults aged 18 or over of either sex will participate in the study. Subjects will undergo a number of physical stress tests (Cycling in a modified atmosphere chamber with variable oxygen levels) to alter their vital signs. Those vital signs will be measured by Lifelight® First and a reference vital signs monitor. The results will be compared to validate the accuracy of Lifelight® First.
The site being utilised is an academic (university) research site which has great experience and suitable facilities within the area being investigated.
Enrollment will take approximately one month.
Testing time for the SpO2, heart rate and respiratory rate will take approximately 60 minutes per person and 45 minutes approximately for the blood pressure.
It is expected the study will take 2 months of solid testing.REC name
London - Dulwich Research Ethics Committee
REC reference
19/LO/0427
Date of REC Opinion
8 Apr 2019
REC opinion
Further Information Favourable Opinion