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

Sponsor

Xim Limited (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05850013

Collaborator

South Tyneside and Sunderland NHS Foundation Trust (Other), Mind Over Matter Medtech Ltd (Other)

500

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Respiratory Disease Febrile Illness Pediatric ALL	Device: 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

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).
Evaluate the impact of subject-specific variables on the vital sign measurements e.g., medication, cosmetics, facial/body hair and skin tone.
Obtain data to understand patient and parent/guardian/carer vital sign measurement habits and preferences
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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Sub Protocol 1 Sub protocol 1 - Blood pressure measured in participants who are able to cooperate and are relatively still Within each study session, compliant participants will have their blood pressure measured using standard-of-care equipment and methods during the same 60 seconds that their other vital signs are measured	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
Sub protocol 2 OPTIONAL Sub protocol 2: Electrocardiogram (ECG) for measurement of Heart rate variability This sub-protocol is relevant for children who would benefit from having a 3-lead ECG to capture beat to beat variability. This will be done in a subset of the participants, and ideally on a subsequent that is representative of the full cohort of participants in terms of age profile, skin tone distribution and illness.	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
Sub protocol 3 The questionnaire will ask questions related to vital sign monitoring habits and preferences, or not, of Lifelight®-type technologies for measuring vital signs instead of standard-of-care methods.	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

Arm

Intervention/Treatment

Sub Protocol 1

Sub protocol 1 - Blood pressure measured in participants who are able to cooperate and are relatively still Within each study session, compliant participants will have their blood pressure measured using standard-of-care equipment and methods during the same 60 seconds that their other vital signs are measured

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

Sub protocol 2

OPTIONAL Sub protocol 2: Electrocardiogram (ECG) for measurement of Heart rate variability This sub-protocol is relevant for children who would benefit from having a 3-lead ECG to capture beat to beat variability. This will be done in a subset of the participants, and ideally on a subsequent that is representative of the full cohort of participants in terms of age profile, skin tone distribution and illness.

Device: Lifelight Junior

Sub protocol 3

The questionnaire will ask questions related to vital sign monitoring habits and preferences, or not, of Lifelight®-type technologies for measuring vital signs instead of standard-of-care methods.

Device: Lifelight Junior

Outcome Measures

Primary Outcome Measures

Overall outcome measure [6 months]
Train Lifelight algorithms across more extensive paediatric clinical ranges in 500 subjects
Heart rate [6 months]
The following accuracy metrics are indicative minimum performance requirements for Lifelight® Junior. VISION-Junior should progress the technology towards these performance targets: • Heart rate o Root mean square error of 5 bpm or lower
Respiratory rate [6 months]
The following accuracy metrics are indicative minimum performance requirements for Lifelight® Junior. VISION-Junior should progress the technology towards these performance targets: • Respiratory rate o Maximum error of 5 breaths per minute for 100% of the measurements
Oxygen saturation level (percentage) [6 months]
The following accuracy metrics are indicative minimum performance requirements for Lifelight® Junior. VISION-Junior should progress the technology towards these performance targets: • Oxygen saturation o Maximum error tolerance of 4%.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children (0-18 years old) attending the paediatric ED or who are inpatients on the paediatric wards at STSFT

Exclusion Criteria:

Critically ill children (judged so by treating physicians), including unconscious children
Children who are non-compliant in terms of excessive movement during the measurement
Children of parents/guardians/carers who are non-English speakers