NCT04003662

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

3 years

First QC Date

June 28, 2019

Last Update Submit

July 23, 2021

Conditions

Vital Signs

Outcome Measures

Primary Outcomes (4)

  • Blood Pressure Readings

    Comparison of digital video data to standard of care measurement

    Single Visit; up to one day

  • Oxygen Saturation Readings

    Comparison of digital video data to standard of care measurement

    Single Visit; up to one day

  • Heart Rate (pulse) Readings

    Comparison of digital video data to standard of care measurement

    Single Visit; up to one day

  • Respiratory Rate

    Comparison of digital video data to standard of care measurement

    Single Visit; up to one day

Study Arms (3)

inpatients

Vital signs measurement - standard of care and prototype

Device: Vital Signs Measurement

outpatients

Vital signs measurement - standard of care and prototype

Device: Vital Signs Measurement

Healthy controls

Vital signs measurement - standard of care and prototype

Device: Vital Signs Measurement

Interventions

Vital Signs MeasurementDEVICE

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

Healthy controlsinpatientsoutpatients

Eligibility Criteria

Age3 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The inclusion/exclusion criteria is limited to the proposed intended use of the device, therefore only individuals, of any sex, over the age of 3 will be included in the study.

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portsmouth Hospitals NHS Trust

Portsmouth, England, PO6 3LY, United Kingdom

Location

MeSH Terms

Interventions

Vital Signs

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosis

Study Design

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

Study Record Dates

First Submitted

June 28, 2019

First Posted

July 1, 2019

Study Start

May 1, 2018

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

July 26, 2021

Record last verified: 2021-07

Locations

GB(1)