Skip to main content
OpenTrials
Completed

NCT Number: NCT03716466

Evaluation of Prophylactic Endotracheal Intubation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Parkland Health Hospital System

Dallas, Texas, 750390, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endotracheal Intubation

Other

Subjects will receive prophylactic endotracheal intubation for upper gastrointestinal endoscopy procedure

No airway intervention

Other

Subjects without prophylactic endotracheal intubation during upper gastrointestinal endoscopy procedure

Primary outcomes

  1. Cardiovascular unplanned event

    Time frame: Postoperative up to 48 hours

    The number of cardiovascular unplanned event after upper gastrointestinal endoscopy, up to 48 hours

Secondary outcomes

  1. Pulmonary unplanned event

    Time frame: Postoperative up to 48 hours

    The number of pulmonary unplanned event after upper gastrointestinal endoscopy, up to 48 hours.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2021
First posted
Oct 23, 2018
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.