跳至主要内容
临床试验/NCT03874169
NCT03874169终止不适用

Detection of Gastrointestinal Bleeding in Intensive Care Patients Via Biosensor Watch

Columbia University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年3月29日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
20
试验地点
1
主要终点
Heart Rate

研究概览

简要总结

The purpose of this study to improve methods of monitoring and diagnosing gastrointestinal bleeding via the E4 wristband, a biosensor watch.

详细描述

The annual occurrence of gastrointestinal (GI) bleeding is approximately 150 per 100,000 in the US and accounts for 300,000 hospitalizations per year with a death rate of 5%. Qualitative assessments of blood tests monitoring patients with or are thought to have GI bleeding can lack accuracy and objectivity, delaying conformation of the bleed through endoscopy. Early endoscopies have been linked to more favorable outcomes for patients with heavier GI bleeding and earlier discharge times for patients with less severe GI bleeding. Additionally, laboratory values are not documented at regular intervals, which makes identifying when GI bleeding exactly occurred difficult. In this study, the investigators aim to improve methods of monitoring and diagnosing GI bleeding via the E4 wristband, a biosensor watch. Using data from the E4 wristband, the investigators will train a model to recognize GI bleeding through analyzing the heart rate and skin conductance of both patients with GI bleeding and who may have GI bleeding while they are not bleeding and while they are bleeding. Monitoring both types of patients while they are and are not bleeding will help the model discern which vital signs are critical. Additionally, the investigators will be using blood tests and other traditional methods of diagnosis to create a standard for vitals that characterize GI bleeding. If the E4 wristband is successfully able to accurately identify when a patient is experiencing GI bleeding, then speed of GI bleeding detection and the ability to monitor GI bleeding will dramatically increase, leading to quicker discharge times, reduced risk of rebleeding, and a lower death rate for afflicted patients.

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

入选标准

  • Patients with a history of gastrointestinal bleeding and/or showing the symptoms of gastrointestinal bleeding.

排除标准

  • Patients who are not showing the symptoms of gastrointestinal bleeding and/or do not have a history of gastrointestinal bleeding.

结局指标

主要结局

Heart Rate

时间窗: Up to 1 year

Using the wristband, heart rate will be collected at a frequency of 64 Hz.

Skin Conductance

时间窗: Up to 1 year

Using the wristband, skin conductance will be collected at a frequency of 4 Hz.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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