跳至主要内容
临床试验/NCT03050983
NCT03050983已完成不适用

Observational Investigation to Determine Clinical Impact of Continuous Surveillance Monitoring (SM) on General Care Floors With a Nested Study to Determine the Clinical Utility of IPI (Integrated Pulmonary Index).

Medtronic - MITG1 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2017年2月15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
440
试验地点
1
主要终点
Clinical Utility of IPI and IPI Alarm

研究概览

简要总结

Single site prospective observational nested study of bedside CS20p monitor on the GCF impeded into a retrospective review of the frequency of escalation of care with intermittent vitals signs compared to continuous respiratory monitoring.

详细描述

Single site observational study of alarms and workflow on the general care floor where continuous surveillance monitoring (SM) with capnography and pulse oximetry is the standard of care before and after the Integrated Pulmonary Index is enabled within the context of a historical review of frequency of escalation of care as a function of the frequency and method of monitoring respiratory status. Observation of alarms will be electronically recorded on a Clinical Observation Tool (COT or iPad) that will have a virtual view of the CS20p measurements and alarm alerts for 24 hours on several patients at the same time. Patients will only be enrolled for 24 hours of observation of alarm status with associated patient activity and clinical interventions. Observation data with IPI disabled prior to implementation of IPI/IPI alarms will be used to evaluate optimal alarm alert settings including an IPI alert when enabled. Observation will continue with IPI enabled and alarms adjusted to study clinical utility of IPI on the GCF.

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
否

入选标准

  • •Spontaneous breathing adults ≥ 18 years of age, both male and female
  • •On dual parameter CS20p monitoring with both capnography and pulse oximetry per Vanderbilt standard of care to monitor patients for respiratory compromise.
  • •Expected minimum duration of 24 hours of continued capnography and pulse oximetry monitoring.

排除标准

  • •Those patients who are expected to be discharged within six hours on the randomly selected observation floor.
  • •Those patients not on the randomly selected floor for observation.
  • •Those subjects randomly removed from the selected floor for observation pool in order to limit the number of subjects to be observed.
  • •Those subjects in rooms with limited Wi-Fi signal quality as per VUMC IT.

结局指标

主要结局

Clinical Utility of IPI and IPI Alarm

时间窗: Not to exceed nine months of observation

Adjusted Hospital Length of Stay in both Phases

次要结局

  • Clinical Impact of continuous surveillance capnography and pulse oximetry monitoring(Not to exceed 24 months of reported escalation of care events to the Principal Investigator)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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