Evaluation of Prophylactic Endotracheal Intubation

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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Bleeding; Intubation;Difficult
• Intervention / Treatment: Other: Endotracheal intubation; Other: No airway intervention

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.

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 750390
      • Parkland Health Hospital System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cases with upper gastrointestinal bleeding.

Description

Inclusion Criteria:

• Age 18 years and older
• Presence of upper gastrointestinal bleeding either presented with hematemesis or melena along with evidence of hemodynamic compromise.
• Received procedural (conscious) sedation
• Undergoing urgent upper gastrointestinal endoscopy procedures

Exclusion Criteria:

• Intubation other than airway protection
• Prior tracheostomy before onset of gastrointestinal bleeding
• Subjects intubated before transfer to gastrointestinal suite
• Subjects without hemodynamic instability
• Subjects with a diagnosis of pneumonia, acute respiratory distress syndrome, myocardial infarction, pulmonary edema, arrhythmia, or cardiac arrest before endoscopy
• Endoscopy done for other than upper gastrointestinal bleeding
• Pregnant subjects

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endotracheal intubation; Cases with prophylactic endotracheal intubation during urgent endoscopy procedure for upper gastrointestinal bleeding .	Other: Endotracheal intubation; Subjects will receive prophylactic endotracheal intubation for upper gastrointestinal endoscopy procedure
No airway intervention; Cases without airway intervention during urgent endoscopy procedure for upper gastrointestinal bleeding	Other: No airway intervention; Subjects without prophylactic endotracheal intubation during upper gastrointestinal endoscopy procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular unplanned event	The number of cardiovascular unplanned event after upper gastrointestinal endoscopy, up to 48 hours	Postoperative up to 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary unplanned event	The number of pulmonary unplanned event after upper gastrointestinal endoscopy, up to 48 hours.	Postoperative up to 48 hours

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Study Director: David Nasir, MD, 214-590-5352

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 11, 2018
• Primary Completion (ACTUAL): December 6, 2018
• Study Completion (ACTUAL): July 9, 2021

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (ACTUAL): October 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: STU 072018-045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No