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Clinical Trial Summary

Upper gastrointestinal (GI) bleeding is defined as patients who either presented with hematemesis or presented with melena along with evidence of hemodynamic compromise. These patients have risk of aspiration of blood along with gastric content. The mortality rate can be 15% to 20% in the cases with variceal bleeding. From a practical standpoint, it is widely accepted that the best way to secure an airway during upper GI bleeding is prophylactic endotracheal intubation (PEI). The aim of this study is to determine the incidence of complications among critically ill patients with upper GI bleeding and received urgent endoscopy.


Clinical Trial Description

This is a prospective observational study. After IRB approval, consecutive patient with upper GI bleeding and undergoing urgent endoscopy will be enrolled to the study over 24 months period. Data pull will be requested from Parkland Office of Research Administration (ORA) regarding eligible subjects and protocol requiring data elements. The data pull will be requested at the end of the 24 months-period. Primary endpoint: The incidence of cardiovascular unplanned event within 48 hours of the upper gastrointestinal endoscopy procedure. Secondary end points: The incidence of pulmonary unplanned event within 48 hours of the upper gastrointestinal endoscopy procedure. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03716466
Study type Observational
Source University of Texas Southwestern Medical Center
Contact
Status Completed
Phase
Start date November 11, 2018
Completion date July 9, 2021

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