Development of a Robust and Reliable Pulse Oximeter for Use by Frontline Healthcare Providers Caring for Children With Pneumonia in Low-income Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 572
- 试验地点
- 4
- 主要终点
- Time to obtain SpO2 reading
研究概览
简要总结
This study is to test the usability of a new pulse oximeter probe designed for children 0-5 years.
详细描述
Pneumonia is the leading infectious cause of death in children under five. World Health Organization guidelines recommend measurement of peripheral oxygen saturation (SpO2) in children with pneumonia to guide treatment. This project focuses on the design of a new 'Lifebox' pulse oximeter probe for use in children 0-5 years of age.
A new oximeter probe compatible with the Lifebox oximeter has been designed to be used for children 0-5 years in all settings.
The aims of the study are to:
- to evaluate the usability of the redesigned Lifebox oximeter probe by an expert user
- to evaluate the usability of the redesigned oximeter probe by trained healthcare workers, against defined product specifications.
- to compare the usability of the redesigned oximeter probe to a market leading probe
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient participants:
- •Inpatients (or child awaiting surgery on pre-operative ward) in Great Ormond Street Hospital, or government facilities in Malawi and Bangladesh
- •Aged 0 - 59 months
- •Clinically stable (as judged by the ward sister and medical team)
- •Parent (or adult with parental responsibility) present
- •Informed consent from the parent (or adult with parental responsibility)
- •Healthcare worker participants:
- •Nursing staff employed at Great Ormond Street Hospital who are trained in the use of pulse oximetry or government healthcare providers working in Malawi and Bangladesh
- •Written informed consent from the healthcare worker
排除标准
- •Patient participants:
- •Unstable or critically unwell patients (as judged by their medical team)
- •Parents (or adult with parental responsibility) who are not able or willing to give informed consent
- •Parents (or adult with parental responsibility) unable to speak English well enough to understand study methods or consent form (UK only)
- •For part of the study assessing usability of the probe by healthcare workers, patients with oxygen saturation 95% or below will be excluded
- •Healthcare worker participants:
- •Healthcare providers who are not trained to use a pulse oximeter
- •Healthcare providers who have not given written informed consent
结局指标
主要结局
Time to obtain SpO2 reading
时间窗: Through completion of study, average one hour
The time to obtain a stable reading will be declared by the healthcare worker or expert and noted by the independent observer, to give a proportion fulfilling the Target Product Profile (TPP).
次要结局
未报告次要终点
研究者
Isabeau Walker
Consultant Paediatric Anaesthetist, Honorary Senior Lecturer Great Ormond Street Hospital NHS Foundation Trust
The Lifebox Foundation