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The VISION-Acute Study

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ClinicalTrials.gov Identifier: NCT04589923
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : February 15, 2021
Sponsor:
Collaborators:
Portsmouth Hospitals NHS Trust
Mind Over Matter Medtech Ltd
Information provided by (Responsible Party):
Xim Limited

Tracking Information
First Submitted Date October 2, 2020
First Posted Date October 19, 2020
Last Update Posted Date February 15, 2021
Actual Study Start Date September 14, 2020
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 9, 2020)
Primary Objective [ Time Frame: 3 months ]
Train Lifelight® oxygen saturation algorithms with hypoxic individuals.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 9, 2020)
  • Secondary Objective 1 [ Time Frame: 3 months ]
    Measure oxygen saturation using Lifelight® with accuracy closer to +/- 4%.
  • Secondary Objective 2 [ Time Frame: 3 months ]
    Measure heart rate using Lifelight® with accuracy closer to RMSE of 3bpm.
  • 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.
  • Secondary Objective 4 [ Time Frame: 3 months ]
    Measure systolic and diastolic blood pressure using Lifelight® with accuracy closer to 5+/- 8mmHg.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The VISION-Acute Study
Official 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
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.

Detailed Description

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Inpatients - adults
Condition
  • Hypertension
  • Hypoxia
  • Hypotension
Intervention
  • Device: Lifelight® Data Collect Blood Pressure Group
    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.
  • Device: Lifelight® Data Collect Oxygen Saturation Group
    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.
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Device: Lifelight® Data Collect Blood Pressure Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 9, 2020)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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
  2. Participants admitted to Intensive Care
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Laura Wiffen +44(0)239228600 ext 5153 laura.wiffen@porthosp.nhs.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04589923
Other Study ID Numbers PHT/2020/50
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Xim Limited
Study Sponsor Xim Limited
Collaborators
  • Portsmouth Hospitals NHS Trust
  • Mind Over Matter Medtech Ltd
Investigators
Principal Investigator: Laura Wiffen Portsmouth Hospitals University NHS Trust
PRS Account Xim Limited
Verification Date February 2021