Vital Sign Comparison Between Lifelight and Standard of Care - Development

Vital Signs Clinical Trial

— VISION-D  

Official title:

Vital Sign Comparison Between Lifelight and Standard of Care - Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04003662
• Other study ID #: PHT/2018/25 IRAS ID 242581
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: May 1, 2021

Study information

• Verified date: July 2021
• Source: Xim Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients and volunteers both with and without medical problems will be recruited; vital sign measurements are taken twice with normal equipment and while recording video data at the same time. The data collected will allow the Artificial Intelligence to develop the LifeLight algorithm to to improve measurement accuracy of its video data based vital signs monitor.

Description:

Vital signs such as heart rate, blood pressure, breathing rate and oxygen levels currently need several pieces of equipment and trained staff in order to be measured properly. The LifeLight app measures the same vital signs using a camera in a phone, tablet, laptop or smart TV. By using very small changes in the colour of your skin, LifeLight's AI system can calculate these values without any extra equipment or training, and without contact.

The aim of this research study is to improve the accuracy of the LifeLight system with a view to a subsequent Validation study to prove the level of accuracy. The investigators will recruit patients, staff and visitors, both with and without medical problems, and take vital sign measurements twice with normal equipment and while recording video data at the same time. This will allow the AI which develops the LifeLight algorithm to make it more accurate, prior to a subsequent study which will validate the results.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9000
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Gender: All
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

• I1. Sufficiently conversant in the English language to satisfy I3.

• I2. Able and willing to comply with all study requirements.

• I3. Able and willing to provide written informed consent to participate (including by parent or legal guardian if under 16 years old).

Exclusion Criteria:

• There are no exclusion criteria.

Related Conditions & MeSH terms

• Vital Signs

Intervention

Device:
• Vital Signs Measurement
Vital signs are measured twice with standard of care equipment while recording digital video data at the same time.

Locations

Country	Name	City	State
United Kingdom	Portsmouth Hospitals NHS Trust	Portsmouth	England

Sponsors (1)

Lead Sponsor	Collaborator
Xim Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure Readings	Comparison of digital video data to standard of care measurement	Single Visit; up to one day
Primary	Oxygen Saturation Readings	Comparison of digital video data to standard of care measurement	Single Visit; up to one day
Primary	Heart Rate (pulse) Readings	Comparison of digital video data to standard of care measurement	Single Visit; up to one day
Primary	Respiratory Rate	Comparison of digital video data to standard of care measurement	Single Visit; up to one day