A Pilot Trial of Continuous Portable Postoperative Hemodynamic And Saturation Monitoring On Hospital Wards
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 879
- 试验地点
- 2
- 主要终点
- Duration of Hypoxemia (SpO2 < 90%) in Minutes
研究概览
简要总结
The study team will collect data for this study from participants who are having surgery and recovering postoperatively on 2 pre-designated hospital units. The study team will use vital signs data from a portable device that participants wear on their wrists as well as conventional vital signs data that is collected when a health care provider comes into their room and collect this information.
A substudy is also being performed with the distribution of surveys to the nursing staff on the floors who are utilizing the ViSi hemodynamic monitors within our institution.
详细描述
This proposed study will provide the necessary preliminary data for a National Institutes of Health Research Grant Project (NIH R01) application that will test the utility of continuous portable hemodynamic monitoring in a large-scale randomized trial. Two separate post surgical hospital units will be randomized to utilize the Sotera ViSi monitoring system or to not utilize the Sotera ViSi monitoring system for a 4 week period of time alternating over the period of 1 year. The study team will assess the effect of unblinded continuous monitoring and the associated alerts on the cumulative duration (min/hour) of each of hypotension, tachycardia, and desaturation. The study team will assess the effect of continuous monitoring and associated alerts on the ordinal clinical intervention outcome which measures the single most extreme/elevated clinical intervention incurred by a patient for any of the 3 outcome variables of interest (hypotension, tachycardia, hypoxia) during the study period with response by staff. The study team will assess the treatment effect on myocardial injury after non-cardiac surgery (MINS) during the study period.
A substudy involving the the medical center nursing staffs' impressions of the device as well as their confidence in its utilization in keeping their assigned patient's safe will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The 2 wards will alternate every 4 weeks as to blinded/unblinded allocations. Blinded will be continuous ward monitoring with alarms silenced and screens covered; unblinded will be continuous monitoring accessible to clinicians with pre-specified alerts at MAP <65 mmHg, heart rate >110 b/m, and SpO2 <90%. Of note, to ensure patient safety and no risk in either arm, factory alarm limits (see table under human subjects protection) at extremes of physiological vital signs will stay on in the blinded/silenced arm, and both arms will have every 4 hourly checks by nursing teams.
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
- •>/= 65 years of age
- •>/= 45 years of age with at least 1 cardiovascular risk (hypertension, diabetes)
- •Requiring a general or regional anesthetic as part of their surgical procedure.
- •Requiring (or anticipated to require) at least a 48 hour hospital stay after surgery.
- •All subjects aged 18 and older who are patients receiving ViSi monitoring on the 2 nursing units involved.
排除标准
- •< 48 hour hospital stay
- •Receiving local anesthetic for their surgical procedure
- •troponins not ordered if <65 years of age without a single cardiovascular risk factor or <45 years of age
结局指标
主要结局
Duration of Hypoxemia (SpO2 < 90%) in Minutes
时间窗: Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)
Duration of Hypoxemia defined as SpO2 \< 90% in Minutes
Duration of Tachycardia in Minutes
时间窗: Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)
Tachycardia defined as \>110 beats/min.
Duration of Hypotension in Minutes
时间窗: Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)
Hypotension defined as MAP \<65 mmHg.
次要结局
- Clinical Nursing Intervention Responses Scale(Ward Admission Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier))