Clinical trial NCT05850013: The Measurement of Vital Signs in Children by Lifelight® Software in Comparison to the Standard of Care
Official title: The Measurement of Vital Signs in Children by Lifelight® Software in Comparison to the Standard of Care The VISION-Junior Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Respiratory Disease
Febrile Illness
Pediatric ALL
Keywords: video
audio
vital signs
Lead sponsor: Xim Limited
Sponsor class: INDUSTRY
Collaborators: name: South Tyneside and Sunderland NHS Foundation Trust
name: Mind Over Matter Medtech Ltd
First posted: 2023-05-09
Enrollment: 504
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall outcome measure
timeFrame: 6 months
measure: Heart rate
timeFrame: 6 months
measure: Respiratory rate
timeFrame: 6 months
measure: Oxygen saturation level (percentage)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sunderland
country: United Kingdom
facility: South Tyneside and Sunderland NHS Foundation Trust
Study officials:
affiliation: South Tyneside and Sunderland Foundation Trust
name: Niall Mullen, MB BCh
role: PRINCIPAL_INVESTIGATOR
References: