Wireless Vital Sign Monitoring in Women After Cesarean Birth in Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Clinical Adequacy Score
研究概览
简要总结
With over 18.5 million procedures performed worldwide and increasing, Cesarean section (CS) is the commonest surgical procedure. Inpatient monitoring is typically intense due to high risk for hemorrhage and other complications in the immediate post-operative period. Vital signs, including heart rate, blood pressure, saturation and temperature are monitored every 10-15 minutes. Maintaining this level of monitoring requires a significant dedication of human resources which is unattainable in resource-limited settings (RLS). Advancements in wireless physiologic monitoring offer a novel strategy to improve current monitoring levels. Through our project, we will evaluate the clinical use of a wireless physiological monitoring system for immediate postpartum monitoring in women after CS.
Our primary aims are:
I) To explore the clinical adequacy of wireless physiologic monitoring vs standard of care (SOC) monitoring immediately after uncomplicated Cesarean section in a RLS II) To explore the usability of wireless physiologic monitoring vs SOC monitoring among healthcare staff in a RLS
详细描述
Basic study design:
This pilot study will take place at Sir Ganga Ram Hospital, Lahore Pakistan as a cluster randomized clinical trial. Pakistan is a developing country with limited resources and a high maternal mortality rate of 189/100,000 live births. The tertiary hospital is located in the heart of historic city of Lahore which has a population of 11 million and the hospital has approximately 24,000 births per year. A conservative estimate of approximately 30 CS occur each day at the hospital.
Intervention:
Units will be randomized to the intervention, use of wireless physiologic monitoring system (WIP), or to SOC. The WIP system will be provided by YHE® BP Doctor Pro Blood Pressure Smartwatch, which is a commericially available device. The device can monitor heart rate
Randomization:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years, 2) undergoing CS for singleton pregnancy, 3) willing to stay in postpartum unit for at least 24 hours, 4) willing to wear sensor during their time at the post-operative monitoring ward, 5) able to provide consent 6) ability to speak Urdu/Punjabi or English
排除标准
- •women with complicated CS (e.g. due to excessive perioperative bleeding), 2) women with immediate-emergency CS due to fetal or maternal disease, 3) no informed, written consent 4) unwilling to wear devices or participate in questionnaires, or 5) known infectious disease including but not limited to viral hepatitis, tuberculosis, or HIV.
结局指标
主要结局
Clinical Adequacy Score
时间窗: 4 months
Composite adequacy score (CAS), is a composite of registered measurements of HR, saturation and BP measured during the first 2 hours after birth. Each registered vital sign will give 1 point.
次要结局
- System Usuability Scale index(4 months)