NCT03874169

Detection of Gastrointestinal Bleeding in Intensive Care Patients Via Biosensor Watch

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastro Intestinal Bleeding

Interventions

Type	Name	Description
DEVICE	E4 wristband	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

Timeline

• Start date: 2019-03-29
• Primary completion: 2021-07-20
• Completion: 2021-07-20
• First posted: 2019-03-14
• Last updated: 2023-05-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study