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临床试验/NCT04220359
NCT04220359已完成不适用

Early Identification of Hospitalized Patients at High-risk for Clinical Deterioration During the First 72-hours in an Internal Medicine Department. A Prospective, Continuous, Physiologic Big-data-analysis Study

Biobeat Technologies Ltd.1 个研究点 分布在 1 个国家目标入组 410 人开始时间: 2020年7月6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
410
试验地点
1
主要终点
Monitoring blood pressure changes in high-risk patients

研究概览

简要总结

This study aims to provide myriad of physiological parameters in patients admitted in an internal medicine department, and which are defined as being in an increased risk of clinical deterioration within the first 72-hours after admission. The investigators will also conduct a retrospective comparison between physiological changes in patients who did deteriorate to those who did not. This will form the basis for the development of an algorithm for early prediction and warning of physiological and clinical deterioration during the first 72-hours of admission.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females 18 years old and above admitted to the internal medicine department
  • On admission, the primary investigator assess their risk to deteriorate during the first 72 hours after admission as reasonably high
  • The patient is assigned to a "monitoring bed" within the department
  • The patient has signed an informed consent form

排除标准

  • Lack of informed consent
  • It is known in advance that the patient cannot take part in the study for a 72-hours period (e.g. a patient that will be taken to surgery within the next 24 hours)
  • Technical inability to attach the Biobeat patch (BB-613PW) to the patients chest

结局指标

主要结局

Monitoring blood pressure changes in high-risk patients

时间窗: 72 hours per individual

The investigators will record blood pressure measurements using a non-invasive wireless monitoring device working continuously for 72 hours in high-risk patients.

次要结局

  • Monitoring cardiac output changes in high-risk patients(72 hours per individual)
  • Monitoring early heart rate changes in high-risk patients(72 hours per individual)
  • Monitoring stroke volume changes in high-risk patients(72 hours per individual)
  • Monitoring blood oxygen saturation changes in high-risk patients(72 hours per individual)
  • Monitoring respiratory rate changes in high-risk patients(72 hours per individual)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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