The VISION-Acute Study

NCT04589923 | Completed DMC

• 1 other identifier: PHT/2020/50
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

AIM: We propose an innovative approach using Lifelight® smart technology that will enable the continued provision of high level patient care at the same time as reducing pressure on nursing and equipment resources. METHOD : Lifelight® is a computer program ("app") which can be used on smart devices that contain a camera. It is able to measure all of the vital signs by measuring very small changes in skin colour that occur each time the heart beats. This means that it does not need to touch the patient. We believe this could be an effective way of measuring vital signs, especially during the COVID-19 pandemic when prevention of cross-contamination between patients is essential. Patients are also likely to be reassured by a contactless approach. During this study, we will recruit two groups of people who are hospitalised with an acute illness. The first group will be people expected to have abnormal blood oxygen levels such as those with acute respiratory problems including those with COVID-19. The second group will be people expected to have abnormal blood pressure. These Lifelight vital signs will be compared to measurements from standard clinical equipment. The exact number of participants recruited will depend on how quickly the app "learns" and how many of the vital signs collected are outside of the normal range. For the first group of participants, we will use a camera to collect data about the changes in their face and use this to teach the app how to measure blood oxygen level and also to check how well the app measures blood oxygen level, heart rate and respiratory rate. For the second group of participants, we will use a camera to collect data about the changes in their face to check how well the app measures blood pressure and respiratory rate. All of the data will be kept secure and participants will not be able to be identified.

Conditions

Hypertension; Hypoxia; Hypotension

Keywords

vital signs; innovation; lifelight; blood pressure; oxygen saturation; contactless; COVID-19; rPPG

Outcome Measures

Primary Outcomes (1)

• Primary Objective

  Train Lifelight® oxygen saturation algorithms with hypoxic individuals.

  3 months

Secondary Outcomes (4)

• Secondary Objective 1

  3 months

• Secondary Objective 2

  3 months

• Secondary Objective 3

  3 months

• Secondary Objective 4

  3 months

Study Arms (2)

Group 1 - participants expected to have abnormal oxygen saturation

Within each study session, participants will have their oxygen saturation, heart rate and respiratory rate measured three times using standard of care equipment and methods. At the same time, video of the participant's face will be captured using the Lifelight® Data Collect app running on a tablet positioned opposite them. The app will upload the RGB data extracted from this video to the cloud for subsequent analysis and processing aligned to the study's primary and secondary objectives only. The app does not return any measurements to the user or participant.

Device: Lifelight® Data Collect Oxygen Saturation Group

Group 2 - participants expected to have abnormal blood pressure

Within each study session, participants will have their blood pressure and respiratory rate measured three times using standard of care equipment. At the same time, video of the participant's face will be captured using the Lifelight® Data Collect app running on a tablet positioned opposite them. The app will upload the RGB data extracted from this video to the cloud for subsequent analysis and processing aligned to the study's secondary objectives only. The app does not return any measurements to the user or participant.

Device: Lifelight® Data Collect Blood Pressure Group

Interventions

Lifelight® Data Collect Blood Pressure Group DEVICE

The staff member will prepare for and take the participant's routine observations using standard clinical equipment during the same 60-second period that video is captured of the participant's face using Lifelight® Data Collect (from which only the RGB data will be uploaded to the cloud). These measurements and RGB data capture will be repeated two times following the initial observations. Once measurements are concluded, the study staff member will complete the post-measurement observation questions.

Group 2 - participants expected to have abnormal blood pressure

Lifelight® Data Collect Oxygen Saturation Group DEVICE

The staff member will prepare for and take the participant's routine observations using standard clinical equipment during the same 60-second period that video is captured of the participant's face using Lifelight® Data Collect (from which only the RGB data will be uploaded to the cloud). These measurements and RGB data capture will be repeated two times following the initial observations. Once measurements are concluded, the study staff member will complete the post-measurement observation questions.

Group 1 - participants expected to have abnormal oxygen saturation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients - adults

You may qualify if:

• Adults ≥18 years old
• Requiring hospital admission with an acute illness
• Potential for vital signs to be outside of the normal ranges on the basis of their clinical status

You may not qualify if:

• Participants unable to undertake simultaneous blood pressure monitoring in both arms will be excluded from Group 2, for example participants with an arterio-venous fistula for dialysis or in cases of lymphoedema following breast cancer surgery
• Participants admitted to Intensive Care

Sponsors & Collaborators

• Xim Limited: lead
• Portsmouth Hospitals NHS Trust: collaborator
• Mind Over Matter Medtech Ltd: collaborator

Study Sites (1)

Portsmouth Hospitals NHS Trust

Portsmouth, England, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Hypertension; Hypoxia; Hypotension; COVID-19

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Laura Wiffen

  Portsmouth Hospitals University NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 19, 2020
• Study Start: September 14, 2020
• Primary Completion: April 29, 2021
• Study Completion: May 7, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)