Cardiovascular Diseases Clinical Trial
— VISION-JrOfficial title:
The Measurement of Vital Signs in Children by Lifelight® Software in Comparison to the Standard of Care The VISION-Junior Study
A prospective basic science study for collection of training and testing data for development of Lifelight® Junior
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | South Tyneside and Sunderland NHS Foundation Trust | Sunderland |
Lead Sponsor | Collaborator |
---|---|
Xim Limited | Mind Over Matter Medtech Ltd, South Tyneside and Sunderland NHS Foundation Trust |
United Kingdom,
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 |
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