Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-29 @ 6:56 PM
Study NCT ID:
NCT03716466
Status:
COMPLETED
Last Update Posted:
2022-05-23
First Post:
2018-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Prophylactic Endotracheal Intubation
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
Evaluation of Prophylactic Endotracheal Intubation in the Patients With Upper Gastrointestinal Bleeding Undergoing Urgent Endoscopy: A Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: