The Measurement of Vital Signs in Children by Lifelight® Software in Comparison to the Standard of Care The VISION-Junior Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 504
- 试验地点
- 1
- 主要终点
- Respiratory rate
研究概览
简要总结
A prospective basic science study for collection of training and testing data for development of Lifelight® Junior
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (0-18 years old) attending the paediatric ED or who are inpatients on the paediatric wards at STSFT
排除标准
- •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
结局指标
主要结局
Respiratory rate
时间窗: 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
Overall outcome measure
时间窗: 6 months
Train Lifelight algorithms across more extensive paediatric clinical ranges in 500 subjects
Oxygen saturation level (percentage)
时间窗: 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%.
Heart rate
时间窗: 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
次要结局
未报告次要终点
