Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04763746 |
| Other study ID # |
IRAS: 289242 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
April 1, 2023 |
Study information
| Verified date |
January 2023 |
| Source |
Xim Limited |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
AIM: To advance the development and accuracy of the Lifelight® app for the measurement of
vital signs, therefore developing a non-invasive and easy-to-perform means of measuring vital
signs which can be implemented across a wide range of settings, both within hospitals and out
in the community.
METHOD: Lifelight® is a computer program ("app") for measuring vital signs 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. The investigators 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. The app uses data from looking at a person's face to
calculate the vital signs. This is possible because there are tiny changes in facial skin
that occur each time the heart beats.
The investigators believe Lifelight® could be an effective way of measuring vital signs. The
app is still under development, which means that it is still "learning" the best match
between the information it collects from the face and the values of vital signs measured
using the standard equipment. The app should become more accurate in calculating the vital
signs as it sees more and more information from patients.
So far, the app has seen data from inpatients, outpatients, patients attending GP surgeries
and healthy people. This has improved its accuracy in measuring vital signs. However, the app
needs to see more information so that it can be sufficiently accurate for specific clinical
applications such as long-term monitoring of hypertension. To do this, it particularly needs
to see information from people with abnormal blood pressures and blood oxygen levels. In
order to capture the full range of observations, the app will need to be trialled with some
of the most critically ill patients - some of these will not have capacity to consent to
participation in the study. It also needs to see more data from people with different skin
tones so the investigators can be sure it is accurate for all patients.
To do this, the investigators will recruit people who are attending one of two hospitals,
either as an inpatient, an outpatient, a friend/relative of a patient, or a member of
hospital staff. The exact number will depend on how quickly the app "learns" and how many of
the vital signs are outside of the normal range. The investigators will take the
participant's vital signs using standard clinical equipment whilst recording a video of their
face. The investigators will use most of these measurements and video to teach the app how to
become more accurate at measuring vital signs. The investigators will keep the remaining data
separate and use it to test how accurate the app is. All of the data will be kept securely.
The investigators will also collect feedback from participants and healthcare staff on their
experiences using the app and information that allows us to assess whether there are any
savings to the healthcare economy through use of this technology.
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 with capacity to consent will be recruited into either Sub-protocol 1, 2 or 3 on
the basis of which vital signs are expected to be abnormal. Participants who lack capacity to
consent to take part in the study will be recruited into Sub-protocol 4.
- Sub-protocol 1 participants will have blood pressure, oxygen saturation and heart rate
measured.
- Sub-protocol 2 participants will have respiratory rate and oxygen saturation measured.
- Sub-protocol 3 participants will have oxygen saturation measured.
- Sub-protocol 4 participants will have blood pressure, heart rate, respiratory rate and
oxygen saturation measured.
Participants may also be recruited to a sub-protocol on the basis of their skin tone. This is
because there are targets within Sub-protocols 1, 2 and 3 related to skin tone.
Not all vital signs are collected in all participants to focus study nurse attention on fewer
tasks and to avoid collection of data that is not subsequently used to meet the study
objectives. This approach should help to keep all aspects of data collection as high quality
as possible and is consistent with the GDPR requirement of data minimisation.
For all Sub-protocol 1, 2, 3 and 4 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 the Data Collect app. Best efforts will be made to
adhere to the Lifelight® measurement conditions listed in Appendix B. These measurements and
video capture will be repeated once more in the case of Sub-protocols 2 and 3, and twice more
in the case of Sub-protocols 1 and 4. Once measurements are concluded, the study staff member
will complete the post-measurement observation questions. In all cases, the cleaning protocol
outlined in Appendix D will be adhered to after each study session.
A selection of Sub-protocol 1, 2 and 3 participants will be asked to complete a questionnaire
related to vital sign monitoring and their preference of Lifelight® or other technologies for
measuring vital signs.
