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Completed

NCT Number: NCT04589923

The VISION-Acute Study

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.

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Key information

Conditions

Hypertension COVID-19 Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Hypotension Hypoxia Infections Lung Diseases Nidovirales Infections Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Portsmouth Hospitals NHS Trust

Portsmouth, England, PO6 3LY, United Kingdom

About this study

Following informed consent, the study staff member will complete a very brief set of demographic and medical history questions, limited to the presence or absence of medical problems and treatment for them.

Participants will be recruited into either Group 1 or Group 2 depending on their previous clinical observations assessed during screening.

  • Group 1 participants will have oxygen saturation, heart rate and respiratory rate measured.
  • Group 2 participants will have blood pressure and respiratory rate measured.

For all participants, the study team will complete a set of pre-measurement observation questions. Background luminosity will be measured using a handheld lux meter. The staff member will then 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Primary Objective

    Time frame: 3 months

    Train Lifelight® oxygen saturation algorithms with hypoxic individuals.

Secondary outcomes

  1. Secondary Objective 1

    Time frame: 3 months

    Measure oxygen saturation using Lifelight® with accuracy closer to +/- 4%.

  2. Secondary Objective 2

    Time frame: 3 months

    Measure heart rate using Lifelight® with accuracy closer to RMSE of 3bpm.

  3. Secondary Objective 3

    Time frame: 3 months

    Measure respiratory rate using Lifelight® with tolerance accuracy closer to 100% of readings within 5 breaths per minute.

  4. Secondary Objective 4

    Time frame: 3 months

    Measure systolic and diastolic blood pressure using Lifelight® with accuracy closer to 5+/- 8mmHg.

Sponsors and collaborators

Lead sponsor

Xim Limited

Industry

Collaborators

  • Mind Over Matter Medtech Ltd
  • Portsmouth Hospitals NHS Trust

Registry information

Official study title

The Measurement of VItal SIgns by Lifelight® Data Collect Software in comparisON to the Standard of Care in Acutely Unwell Patients - The VISION-Acute Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 19, 2020
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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