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

NCT05850013 | Completed

• 1 other identifier: IRAS Reference: 321956
• Study Type: observational
• Target: 504
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Diseases; Respiratory Disease; Febrile Illness; Pediatric ALL

Keywords

video; audio; vital signs

Outcome Measures

Primary Outcomes (4)

• Overall outcome measure

  Train Lifelight algorithms across more extensive paediatric clinical ranges in 500 subjects

  6 months

• 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

• 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

• 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

Study Arms (3)

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

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

Interventions

Lifelight Junior DEVICE

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 1; Sub protocol 2; Sub protocol 3

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

We will be recruiting 500 child participants in the paediatric emergency department (PED) and hospital wards. The number will also include particiapnts for sub-protocols to measure blood pressure and record an electrocardiogram (ECG) in compliant and eligible participants and to conduct post-measurement questionnaires. A pilot project involving up to 10% (50) participants will run for 3 weeks in advance of the study with the aim of identifying the most efficient and effective way to deliver the study activities.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xim Limited: lead
• South Tyneside and Sunderland NHS Foundation Trust: collaborator
• Mind Over Matter Medtech Ltd: collaborator

Study Sites (1)

South Tyneside and Sunderland NHS Foundation Trust

Sunderland, SR4 7TP, United Kingdom

Location

Related Publications (1)

• Misra G, Wegerif S, Fairlie L, Kapoor M, Fok J, Salt G, Halbert J, Maconochie I, Mullen N. The Measurement of Vital Signs in Pediatric Patients by Lifelight Software in Comparison to the Standard of Care: Protocol for the VISION-Junior Observational Study. JMIR Res Protoc. 2025 Mar 14;14:e58334. doi: 10.2196/58334.

  PMID: 40085833 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Respiration Disorders; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Niall Mullen, MB BCh

  South Tyneside and Sunderland Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: May 9, 2023
• Study Start: May 1, 2023
• Primary Completion: August 31, 2023
• Study Completion: April 1, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)