NCT05850013

The Measurement of Vital Signs in Children by Lifelight® Software in Comparison to the Standard of Care

The Measurement of Vital Signs in Children by Lifelight® Software in Comparison to the Standard of Care The VISION-Junior Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 504 (actual)
• Sponsor: Xim Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective basic science study for collection of training and testing data for development of Lifelight® Junior

Detailed description

This study will be hospital-based, including paediatric emergency department (PED), inpatient wards and outpatient departments). The participants will have their vital signs (such as heart rate, respiratory rate, oxygen saturation, blood pressure and temperature) measured using standard-of-care methods. Concurrent with this, videos of the participants' face/torso, and audio of the sounds made by the participants (cry, wheeze, cough) will be recorded. These data will later be used to train the Lifelight® Junior algorithms so that the technology can help in detection of illness and deterioration in children. Primary Objective Collect the data needed to develop Lifelight® Junior so that it can measure the heart rate, respiratory rate and oxygen saturation of children. Secondary Objective 1. Assess the feasibility of developing other (direct or indirect) measurement functions in Lifelight® Junior, including temperature, blood pressure, heart rate variability and audio analysis (cry, wheeze, cough). 2. Evaluate the impact of subject-specific variables on the vital sign measurements e.g., medication, cosmetics, facial/body hair and skin tone. 3. Obtain data to understand patient and parent/guardian/carer vital sign measurement habits and preferences 4. Assess the usability of Lifelight® Junior for measuring vital signs in children To ensure the study collects data that can train Lifelight® Junior in an efficient way, the recruitment should be divided as follows: * At least 12% of study participants should fall into each of the following age bands: * Age 0-1 * Age 1-2 * Age 2-5 * Age 5-11 * Age 11-14 * Age 14-18 * At least 40% of the study participants shall be male and at least 40% shall be female. * At least 40% of the study participants shall be each of the following: * Febrile (≥ 38°C) measured how? * Afebrile * Ill (as judged by the clinical staff), of whom at most 50% shall have an acute respiratory illness e.g., bronchiolitis, asthma, viral induced wheeze, pneumonia, croup, etc. * Well, including children with a minor injury Ideally, 15% of participants should have a Fitzpatrick skin tone of 4, 5 or 6 First reference to this - need to bring it in earlier and to reference it. However, this is not a hard target as achieving this figure is dependent on the demographic diversity of the study region.

Conditions

• Cardiovascular Diseases
• Respiratory Disease
• Febrile Illness
• Pediatric ALL

Interventions

Type	Name	Description
DEVICE	Lifelight Junior	Lifelight® is an app developed by xim that measures VS including heart rate, respiratory rate and blood pressure. All you need to do to have these vital signs measured is look at your smartphone or tablet camera for 20-40 seconds. The app has used data from over 1 million heartbeats to learn how to measure these vital signs in adults. The technology is already available for doctors and nurses to use with adult patients in some specific scenarios

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-08-31
• Completion: 2024-04-01
• First posted: 2023-05-09
• Last updated: 2024-07-18

Locations

1 site across 1 country: United Kingdom