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
BackgroundMeasuring vital signs (VS) is important in potentially unwell children, as a change in VS may indicate a more serious infection than is clinically apparent or herald clinical deterioration. However, currently available methods are not suitable for regular measuremen...
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JMIR Publications
2025-03-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2025/1/e58334 |
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| author | Gauri Misra Simon Wegerif Louise Fairlie Melissa Kapoor James Fok Gemma Salt Jay Halbert Ian Maconochie Niall Mullen |
| author_facet | Gauri Misra Simon Wegerif Louise Fairlie Melissa Kapoor James Fok Gemma Salt Jay Halbert Ian Maconochie Niall Mullen |
| author_sort | Gauri Misra |
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BackgroundMeasuring vital signs (VS) is important in potentially unwell children, as a change in VS may indicate a more serious infection than is clinically apparent or herald clinical deterioration. However, currently available methods are not suitable for regular measurement of VS in the home or community setting, and adherence can be poor. The COVID-19 pandemic highlighted a need for the contactless measurement of VS by nonclinical personnel, reinforced by the growing use of telemedicine. The Lifelight app is being developed as a medical device for the contactless measurement of VS using remote photoplethysmography via the camera on smart devices. The VISION-D (Measurement of Vital Signs by Lifelight Software in Comparison to the Standard of Care—Development) and -V (Validation) studies demonstrated the accuracy of the app compared with standard of care (SOC) measurement of blood pressure, pulse rate (PR), and respiratory rate (RR) in adults, supporting certification of Lifelight as a class I Conformité Européenne medical device.
ObjectiveTo support the development of the Lifelight app for pediatric patients, the VISION-Junior study is collecting high-quality data that will be used to develop algorithms for the measurement of VS (PR, RR, and oxygen saturation) in pediatric patients. The accuracy of the app will be assessed against SOC measurements made simultaneously with app measurements.
MethodsThe study is recruiting pediatric patients (younger than 18 years of age) attending the Sunderland Royal Hospital pediatric emergency department of the South Tyneside and Sunderland National Health Service Foundation Trust. High-resolution videos of the face (and torso in children younger than 5 years of age) and audio recordings (to explore the value of crying, wheezing, coughing, and other sounds in predicting illness) are made using the Lifelight Data Collect app. VS are measured simultaneously using SOC methods (finger clip sensor for PR and oxygen saturation; manual counting of RR). Feedback from patients, parents, carers, and nurses who use Lifelight is collected via questionnaires. Anticipated recruitment is 500 participants, with subtargets for age, sex, and skin tone distribution (Fitzpatrick 6-point scale). Early data will be used to refine the algorithms. A separate dataset will be retained to test the performance of the app against predefined targets.
ResultsThe study started on June 12, 2023, and reached its recruitment target (n=532) in April 2024 after extending the deadline. Algorithm refinement is in progress, after which the performance of Lifelight will be compared with the SOC measurement of VS. The analyses are expected to be completed by mid-August 2024.
ConclusionsData collected in this study will be used to develop and assess the accuracy of the app for the measurement of VS in pediatric patients of all ages.
Trial RegistrationClinicalTrials.gov NCT05850013; https://clinicaltrials.gov/study/NCT05850013
International Registered Report Identifier (IRRID)DERR1-10.2196/58334 |
| format | Article |
| id | doaj-art-3b95c57504e049f59c466791dd78dcbc |
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| issn | 1929-0748 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | JMIR Publications |
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| spelling | doaj-art-3b95c57504e049f59c466791dd78dcbc2025-08-20T02:57:07ZengJMIR PublicationsJMIR Research Protocols1929-07482025-03-0114e5833410.2196/58334The Measurement of Vital Signs in Pediatric Patients by Lifelight Software in Comparison to the Standard of Care: Protocol for the VISION-Junior Observational StudyGauri Misrahttps://orcid.org/0009-0002-5075-1323Simon Wegerifhttps://orcid.org/0000-0002-3363-6908Louise Fairliehttps://orcid.org/0009-0000-9326-5750Melissa Kapoorhttps://orcid.org/0000-0002-1811-2401James Fokhttps://orcid.org/0009-0007-6750-2872Gemma Salthttps://orcid.org/0009-0003-2021-4321Jay Halberthttps://orcid.org/0000-0003-1048-5876Ian Maconochiehttps://orcid.org/0000-0001-6319-8550Niall Mullenhttps://orcid.org/0000-0003-2035-7050 BackgroundMeasuring vital signs (VS) is important in potentially unwell children, as a change in VS may indicate a more serious infection than is clinically apparent or herald clinical deterioration. However, currently available methods are not suitable for regular measurement of VS in the home or community setting, and adherence can be poor. The COVID-19 pandemic highlighted a need for the contactless measurement of VS by nonclinical personnel, reinforced by the growing use of telemedicine. The Lifelight app is being developed as a medical device for the contactless measurement of VS using remote photoplethysmography via the camera on smart devices. The VISION-D (Measurement of Vital Signs by Lifelight Software in Comparison to the Standard of Care—Development) and -V (Validation) studies demonstrated the accuracy of the app compared with standard of care (SOC) measurement of blood pressure, pulse rate (PR), and respiratory rate (RR) in adults, supporting certification of Lifelight as a class I Conformité Européenne medical device. ObjectiveTo support the development of the Lifelight app for pediatric patients, the VISION-Junior study is collecting high-quality data that will be used to develop algorithms for the measurement of VS (PR, RR, and oxygen saturation) in pediatric patients. The accuracy of the app will be assessed against SOC measurements made simultaneously with app measurements. MethodsThe study is recruiting pediatric patients (younger than 18 years of age) attending the Sunderland Royal Hospital pediatric emergency department of the South Tyneside and Sunderland National Health Service Foundation Trust. High-resolution videos of the face (and torso in children younger than 5 years of age) and audio recordings (to explore the value of crying, wheezing, coughing, and other sounds in predicting illness) are made using the Lifelight Data Collect app. VS are measured simultaneously using SOC methods (finger clip sensor for PR and oxygen saturation; manual counting of RR). Feedback from patients, parents, carers, and nurses who use Lifelight is collected via questionnaires. Anticipated recruitment is 500 participants, with subtargets for age, sex, and skin tone distribution (Fitzpatrick 6-point scale). Early data will be used to refine the algorithms. A separate dataset will be retained to test the performance of the app against predefined targets. ResultsThe study started on June 12, 2023, and reached its recruitment target (n=532) in April 2024 after extending the deadline. Algorithm refinement is in progress, after which the performance of Lifelight will be compared with the SOC measurement of VS. The analyses are expected to be completed by mid-August 2024. ConclusionsData collected in this study will be used to develop and assess the accuracy of the app for the measurement of VS in pediatric patients of all ages. Trial RegistrationClinicalTrials.gov NCT05850013; https://clinicaltrials.gov/study/NCT05850013 International Registered Report Identifier (IRRID)DERR1-10.2196/58334https://www.researchprotocols.org/2025/1/e58334 |
| spellingShingle | Gauri Misra Simon Wegerif Louise Fairlie Melissa Kapoor James Fok Gemma Salt Jay Halbert Ian Maconochie Niall Mullen 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 Research Protocols |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | measurement of vital signs in pediatric patients by lifelight software in comparison to the standard of care protocol for the vision junior observational study |
| url | https://www.researchprotocols.org/2025/1/e58334 |
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