Infant Pulse Oximetry in Pakistan (iPOP) Study: Utility and Feasibility of Integrating Pulse Oximetry Into the Routine Assessment of Young Infants at First-level Clinics in Karachi, Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,149
- 试验地点
- 2
- 主要终点
- Prevalence of hypoxemia
研究概览
简要总结
Hypoxemia is an abnormally low concentration of oxygen in the blood, and is an important sign of cardio-respiratory compromise in acutely ill patients. Pulse oximetry (PO) is a rapid, portable, non-invasive and accurate method of measuring arterial hemoglobin oxygenation (Sp02), and can therefore be readily implemented to detect hypoxemia in the clinical setting. In this research study, we propose to test the hypothesis that the use of pulse oximetry to detect hypoxemia by first-level health workers' in Karachi, Pakistan is useful and feasible for the identification of the infants most urgently in need of medical care. We will enroll 1,400 infants 0-59 days of age who present to one of two primary health centers in Karachi. Infants will undergo brief clinical assessment by a community health worker (CHW) based on the WHO/UNICEF Integrated Management of Neonatal and Child Illness (IMNCI) algorithm, assessment by two pulse oximetry devices, and examination by a physician. The primary outcomes include prevalence of hypoxemia, feasibility of PO (e.g., time to obtain measurement, number of infants for who repeat measurements are required), and concordance between paired measurements on separate devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 59 Days(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant presenting to the Bilal or Bhains PHC in Karachi, Pakistan
- •Age 0 - 59 days
排除标准
- •Clinic visit is for scheduled injectable antibiotic administration (e.g., SAT trial)
结局指标
主要结局
Prevalence of hypoxemia
时间窗: Over the duration of hopsital stay, on average 24 hours
次要结局
- Validity of PO(Baseline, +2 hours)
- Operational Feasibility(Baseline, +2 hours)
- Comparison of PO Measurements(Baseline, +2 hours)
研究者
Daniel Roth
Staff Physician, Paediatric Medicine
The Hospital for Sick Children
