An observational study in Gastro Intestinal Bleeding, sponsored by Columbia University. Terminated at 1 site in United States. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2023-05-03.
Sponsored by Columbia University · Observational
The purpose of this study to improve methods of monitoring and diagnosing gastrointestinal bleeding via the E4 wristband, a biosensor watch.
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.
339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.
This study's enrollment of 20 is below the median of 200 across 116 observational studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients will be selected from the intensive care unit (ICU) in the Milstein Hospital Building at Columbia University.
Exclusion Criteria:
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
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
Heart Rate
Using the wristband, heart rate will be collected at a frequency of 64 Hz.
Time frame: Up to 1 year
Skin Conductance
Using the wristband, skin conductance will be collected at a frequency of 4 Hz.
Time frame: Up to 1 year
Plan to share: No — There is no plan to share with other researchers outside of the research team.
This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Columbia University