The Measurement of Vital Signs in Children by Lifelight® Software in Comparison to the Standard of Care (VISION-Jr)
The Measurement of Vital Signs in Children by Lifelight® Software in Comparison to the Standard of Care The VISION-Junior Study
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Sunderland, United Kingdom, SR4 7TP
- South Tyneside And Sunderland NHS Foundation Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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
|
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.
|
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall outcome measure
Time Frame: 6 months
|
Train Lifelight algorithms across more extensive paediatric clinical ranges in 500 subjects
|
6 months
|
|
Heart rate
Time Frame: 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 |
6 months
|
|
Respiratory rate
Time Frame: 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 |
6 months
|
|
Oxygen saturation level (percentage)
Time Frame: 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%. |
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Niall Mullen, MB BCh, South Tyneside and Sunderland Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRAS Reference: 321956
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.