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临床试验/NCT05280574
NCT05280574已完成不适用

Continuous Ward Monitoring With the GE Portrait Mobile Monitoring Solution: the COSMOS Trial A Pilot Study

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2022年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
1
主要终点
Phase 2- Cumulative Duration of Vital Sign Abnormalities

研究概览

简要总结

The investigators plan a pilot study to evaluate patient tolerance of the GE Portrait Mobile Monitoring Solution, along with appropriate alert thresholds, and clinical utility. Data obtained in the proposed pilot cohort will guide design of a future robust randomized trial comparing clinical interventions and serious complications with blinded versus unblinded continuous ward monitoring.

详细描述

The investigators plan a pilot study to evaluate patient tolerance of the GE Portrait Mobile Monitoring Solution, along with appropriate alert thresholds, and clinical utility. The system is a novel battery-powered untethered monitor for continuous monitoring of oxygen saturation, respiratory rate, and pulse rate that is designed for use by patients on surgical wards. The initial phase will evaluate patient tolerance, with clinicians and patients blinded to monitor data. Results will be used to evaluate the frequency of respiratory events and pulse rate abnormalities. These data will be used to design clinical alert settings, based on various durations at various thresholds (e.g., saturation <85% for >1 minute). Our main goal will be to identify clinically meaningful vital sign abnormalities with a minimum of false alerts. Secondarily, the investigators will evaluate the frequency and duration of abnormalities, and the fraction that are detected clinically.

In the second phase of the pilot, clinicians will be unblinded to the GE Portrait monitors, and alerts provided based on the durations and threshold identified in the initial part of the pilot. The primary outcomes will be clinician tolerance and the extent to which clinicians believe that vital sign trending and alerts provided useful information rather than distraction. Specifically, the investigators will assess the fraction of alerts that clinicians deemed meaningful, and the fraction that resulted in clinical interventions. In the third phase of the pilot, the durations and thresholds for saturation, respiratory rate, and pulse rate that trigger alerts will be adjusted based on results from the second phase.

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

入选标准

  • Are admitted to one of the wards equipped with the GE Portrait Mobile Solution.
  • Are designated American Society of Anesthesiologists physical status 1-
  • Had major noncardiac surgery lasting at least 1.5 hours.
  • Are expected to remain hospitalized at least two postoperative nights.
  • Had general anesthesia with or without neuraxial anesthesia.

排除标准

  • Have language, vision, or hearing impairments that may compromise continuous monitoring.
  • Are designated Do Not Resuscitate, hospice, or receiving end of life care
  • Have previously participated in the study.

结局指标

主要结局

Phase 2- Cumulative Duration of Vital Sign Abnormalities

时间窗: Up to 72 hours after surgery

The vital sign abnormalities is a 5-component composite including the durations of SpO2 \<85%, heart rate \<45/min, heart rate \>130/min, respiratory rate \<4/min and respiratory rate \>30/min.

次要结局

  • Phase 2 - Alerts Deemed Meaningful(During postoperative 72 hours)
  • Phase 2 - Clinical Interventions to Meaningful Alarms(During postoperative 72 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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