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

Completed

• Conditions: Cardiovascular Diseases; Respiratory Disease; Febrile Illness; Pediatric ALL

• Registration Number: NCT05850013
• Lead Sponsor: Xim Limited

Brief 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.

Study Timeline

• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-04-27
• Study Start: 2023-05-01
• Study First Posted: 2023-05-09
• Primary Completion: 2023-08-31
• Study Completion: 2024-04-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 504

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Overall outcome measure	6 months	Train Lifelight algorithms across more extensive paediatric clinical ranges in 500 subjects
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%.
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

Trial Locations

Locations (1)

South Tyneside and Sunderland NHS Foundation Trust; 🇬🇧 Sunderland, United Kingdom