Detection of Gastrointestinal Bleeding in Intensive Care Patients Via Biosensor Watch

Terminated

• Conditions: Gastro Intestinal Bleeding
• Interventions: Device: E4 wristband

• Registration Number: NCT03874169
• Lead Sponsor: Columbia University

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-14
• Study Start: 2019-03-29
• Primary Completion: 2021-07-20
• Study Completion: 2021-07-20
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High-Risk of GI Bleed	E4 wristband	Patients that have a high risk of having a gastrointestinal bleed upon admission into the ICU based on their medical history and symptoms. These patients will have a biosensor watch, the E4 wristband, placed on them to monitor their vital signs.

Primary Outcome Measures

Name	Time	Method
Heart Rate	Up to 1 year	Using the wristband, heart rate will be collected at a frequency of 64 Hz.
Skin Conductance	Up to 1 year	Using the wristband, skin conductance will be collected at a frequency of 4 Hz.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States