The VISION-Acute Study

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04589923
• Other study ID #: PHT/2020/50
• Status: Completed
• Start date: September 14, 2020
• Est. completion date: May 7, 2022

Study information

• Verified date: July 2022
• Source: Xim Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: May 7, 2022
• Est. primary completion date: April 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypotension
• Hypoxia

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Portsmouth Hospitals NHS Trust	Portsmouth	England

Sponsors (3)

Lead Sponsor	Collaborator
Xim Limited	Mind Over Matter Medtech Ltd, Portsmouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Objective	Train Lifelight® oxygen saturation algorithms with hypoxic individuals.	3 months
Secondary	Secondary Objective 1	Measure oxygen saturation using Lifelight® with accuracy closer to +/- 4%.	3 months
Secondary	Secondary Objective 2	Measure heart rate using Lifelight® with accuracy closer to RMSE of 3bpm.	3 months
Secondary	Secondary Objective 3	Measure respiratory rate using Lifelight® with tolerance accuracy closer to 100% of readings within 5 breaths per minute.	3 months
Secondary	Secondary Objective 4	Measure systolic and diastolic blood pressure using Lifelight® with accuracy closer to 5+/- 8mmHg.	3 months