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

Cardiovascular Diseases Clinical Trial

— VISION-Jr  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05850013
• Other study ID #: IRAS Reference: 321956
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: April 2023
• Source: Xim Limited
• Contact: Niall Mullen, MB BCh MRCPCH
• Phone: (0191) 5656256
• Email: niall.mullen[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 1, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Febrile Illness
• Pediatric ALL
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

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

Locations

Country	Name	City	State
United Kingdom	South Tyneside and Sunderland NHS Foundation Trust	Sunderland

Sponsors (3)

Lead Sponsor	Collaborator
Xim Limited	Mind Over Matter Medtech Ltd, South Tyneside and Sunderland NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall outcome measure	Train Lifelight algorithms across more extensive paediatric clinical ranges in 500 subjects	6 months
Primary	Heart rate	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	6 months
Primary	Respiratory rate	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	6 months
Primary	Oxygen saturation level (percentage)	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%.	6 months