The Measurement of VItal SIgns by Lifelight® Software in comparisON to the Standard of Care - Multi-site Development

Summary

Participation Requirements

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...

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.

Tracking Information