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临床试验/NCT01654835
NCT01654835撤回不适用

A Effectiveness Trial of Early Hemodynamic Support in Patients Demonstrating a Low Systolic Blood Pressure

The Cleveland Clinic2 个研究点 分布在 1 个国家开始时间: 2012年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
duration of time having low blood pressure

研究概览

简要总结

The investigators thus propose to use an innovative randomized effectiveness trial design to test the theory that early automatic identification of a ¡ Low Systolic Blood Pressure¡± clinical condition and decision-support alerts will prompt earlier hemodynamic support and a consequently reduce the duration of such conditions. Specifically, the investigators will test the hypothesis that providing DSS alerts in regards to hypotension reduces the duration of hypotensive episodes. The core of the investigators study will be an existing electronic anesthesia record and smart-alarm decision-support system. All patients undergoing surgery at Hillcrest will be randomly assigned to routine care or to DSS support. In patients assigned to DSS support, a systolic blood pressure less than 80 mmHg will generate a warning within three minutes after detection. Clinicians will be free to act on the alert, ignore the alert, or to consider the provided information without acting on it. The randomization, complete anesthesia record, detailed record of hypotensive events, alerts provided, clinician responses, and SAP response, will be captured by the investigators electronic record-keeping system. The investigators primary outcome will be the duration of time the patient has a systolic blood pressure less than 80 mmHg. Secondary outcome will be duration of hospitalization. The investigators will assess the effect of the alert on the primary outcome of time to SBP returning to above 80 mmHg using survival analysis, with time to event censored (and considered a non-event) at either the end of surgery or end of monitoring if patient did not return to above 80 mmHg.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients will be enrolled in the study if systolic blood pressure (SBP) is measured to be below 80 mmHg for at least 3 minutes, either with the arterial line or cuff (non-invasive blood pressure, NIBP).

排除标准

  • 未提供

研究组 & 干预措施

low blood pressure alert

Active Comparator

A Low Blood Pressure condition as specified (SAP <80 mmHg)will trigger an page to be sent to all anesthesia providers in <1 min that will read: "A Low Blood Pressure condition has been detected. Consider hemodynamic support."

干预措施: low blood pressure alert (Other)

no low blood pressure alert

Placebo Comparator

The Low Blood Pressure condition will be monitored by treatment team, but additional alert will not be sent to treatment team.

干预措施: standard of care (Other)

结局指标

主要结局

duration of time having low blood pressure

时间窗: day 1

We plan to test the hypothesis that providing hypotension alerts reduces the duration of time patients spend in a low blood pressure condition.

次要结局

  • hypotension(day 1)
  • duration of hospitalization(up to day 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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