Continuous Ward Monitoring With the GE Portrait Mobile Monitoring Solution: the COSMOS Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 1
- 主要终点
- Hypoxemia
研究概览
简要总结
The investigators plan to determine whether unblinded continuous ward monitoring with the GE Portrait Mobile Monitoring Solution and nursing alerts reduces vital sign abnormalities in patients recovering from major noncardiac surgery.
详细描述
Primary Aim. Determine whether unblinded continuous ward monitoring with the GE Portrait Mobile Monitoring Solution and nursing alerts reduces vital sign abnormalities in patients recovering from major noncardiac surgery.
Primary hypothesis. Unblinded continuous ward monitoring and nurse alerts reduces vital sign abnormalities during the initial 48 postoperative hours after major non-cardiac surgery while patients remain hospitalized.
Secondary Aim. Determine whether continuous ward saturation, ventilation, and pulse rate monitoring reduces a composite of substantive respiratory and cardiovascular interventions.
Secondary hypothesis. Unblinded continuous ward monitoring increases a composite of clinical interventions for desaturation, hypoventilation, tachypnea, tachycardia, and bradycardia within 48 hours after major non-cardiac surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are expected to be admitted to one of the wards equipped with the GE Portrait Mobile Monitoring Solution;
- •Are ≥18 years old;
- •Are designated American Society of Anesthesiologists physical status 1-4;
- •Are scheduled for major noncardiac surgery lasting at least 1.5 hours;
- •Are expected to remain hospitalized at least one postoperative night;
- •Are expected to have general or neuraxial anesthesia.
排除标准
- •Have language, vision, or hearing impairments that might compromise continuous monitoring;
- •Are designated Do Not Resuscitate, hospice, or receiving end of life care;
- •Are expected to have telemetry monitoring;
- •Have previously participated in the study.
研究组 & 干预措施
Blinded monitoring
Continuous postoperative vital sign monitoring blinded to clinicians and investigators.
干预措施: Blinded postoperative vital sign monitoring (Device)
Unblinded monitoring
Continuous postoperative vital sign monitoring unblinded to clinicians and investigators.
干预措施: Unblinded postoperative vital sign monitoring (Device)
结局指标
主要结局
Hypoxemia
时间窗: 48 postoperative hours.
Area of oxygen saturation defined as SpO2 ≤85%.
Inadequate or excessive ventilation
时间窗: 48 postoperative hours.
Area of inadequate or excessive ventilation defined as respiratory rate ≤4/min or ≥30/min.
Bradycardia and tachycardia
时间窗: 48 postoperative hours.
Area of inadequate or excessive heart rate defined as ≤40/min or ≥130/min.
次要结局
- The fraction of patients who have a composite of interventions potentially related to postoperative vital sign abnormalities.(48 postoperative hours.)