Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The VISION-Acute Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04589923
Recruitment Status : Not yet recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Portsmouth Hospitals NHS Trust
Mind Over Matter Medtech Ltd
Information provided by (Responsible Party):
Xim Limited

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.


Condition or disease Intervention/treatment
Hypertension Hypoxia Hypotension Device: Lifelight® Data Collect Blood Pressure Group Device: Lifelight® Data Collect Oxygen Saturation Group

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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
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
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 Outcome Measures :
  1. Primary Objective [ Time Frame: 3 months ]
    Train Lifelight® oxygen saturation algorithms with hypoxic individuals.


Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inpatients - adults
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04589923


Contacts
Layout table for location contacts
Contact: Laura Wiffen +44(0)239228600 ext 5153 laura.wiffen@porthosp.nhs.uk

Locations
Layout table for location information
United Kingdom
Portsmouth Hospitals NHS Trust
Portsmouth, England, United Kingdom, PO6 3LY
Sponsors and Collaborators
Xim Limited
Portsmouth Hospitals NHS Trust
Mind Over Matter Medtech Ltd
Investigators
Layout table for investigator information
Principal Investigator: Laura Wiffen Portsmouth Hospitals University NHS Trust
Layout table for additonal information
Responsible Party: Xim Limited
ClinicalTrials.gov Identifier: NCT04589923    
Other Study ID Numbers: PHT/2020/50
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xim Limited:
vital signs
innovation
lifelight
blood pressure
oxygen saturation
contactless
COVID-19
rPPG
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypotension
Hypoxia
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms, Respiratory