NCT03716466

Evaluation of Prophylactic Endotracheal Intubation

Evaluation of Prophylactic Endotracheal Intubation in the Patients With Upper Gastrointestinal Bleeding Undergoing Urgent Endoscopy: A Prospective Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Intubation;Difficult
• Gastrointestinal Bleeding

Interventions

Type	Name	Description
OTHER	Endotracheal intubation	Subjects will receive prophylactic endotracheal intubation for upper gastrointestinal endoscopy procedure
OTHER	No airway intervention	Subjects without prophylactic endotracheal intubation during upper gastrointestinal endoscopy procedure

Timeline

• Start date: 2018-11-11
• Primary completion: 2018-12-06
• Completion: 2021-07-09
• First posted: 2018-10-23
• Last updated: 2022-05-23

Locations

1 site across 1 country: United States