Detection of Gastrointestinal Bleeding in Intensive Care Patients Via Biosensor Watch

NCT03874169 | Terminated DMC FDA Device

• 1 other identifier: AAAS1510
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastro Intestinal Bleeding

Keywords

Biosensor watch; E4 Wristband; Intensive Care Unit; GI bleeding

Outcome Measures

Primary Outcomes (2)

• Heart Rate

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

  Up to 1 year

• Skin Conductance

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

  Up to 1 year

Study Arms (1)

High-Risk of GI Bleed

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.

Device: E4 wristband

Interventions

E4 wristband DEVICE

A biosensor watch that monitors the patient's heartbeat, heart rate variability, skin conductance, and temperature in order to discover if they are having a GI bleed

High-Risk of GI Bleed

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from the intensive care unit (ICU) in the Milstein Hospital Building at Columbia University.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• Kim BS, Li BT, Engel A, Samra JS, Clarke S, Norton ID, Li AE. Diagnosis of gastrointestinal bleeding: A practical guide for clinicians. World J Gastrointest Pathophysiol. 2014 Nov 15;5(4):467-78. doi: 10.4291/wjgp.v5.i4.467.

  PMID: 25400991 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chin Hur, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 14, 2019
• Study Start: March 29, 2019
• Primary Completion: July 20, 2021
• Study Completion: July 20, 2021
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)