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临床试验/NCT05850013
NCT05850013已完成不适用

The Measurement of Vital Signs in Children by Lifelight® Software in Comparison to the Standard of Care The VISION-Junior Study

Xim Limited1 个研究点 分布在 1 个国家目标入组 504 人开始时间: 2023年5月1日最近更新:
适应症

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

  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

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

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

研究者

发起方
Xim Limited
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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