Evaluation of Prophylactic Endotracheal Intubation

May 16, 2022 updated by: Dawood Nasir, University of Texas Southwestern Medical Center

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endotracheal intubation
Cases with prophylactic endotracheal intubation during urgent endoscopy procedure for upper gastrointestinal bleeding .
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
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
Time Frame: Postoperative up to 48 hours
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
Time Frame: Postoperative up to 48 hours
The number of pulmonary unplanned event after upper gastrointestinal endoscopy, up to 48 hours.
Postoperative up to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: David Nasir, MD, 214-590-5352

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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