Evaluation of Prophylactic Endotracheal Intubation

Completed

• Conditions: Intubation;Difficult; Gastrointestinal Bleeding
• Interventions: Other: No airway intervention; Other: Endotracheal intubation

• Registration Number: NCT03716466
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-10-22
• Study First Posted: 2018-10-23
• Study Start: 2018-11-11
• Primary Completion: 2018-12-06
• Study Completion: 2021-07-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No airway intervention	No airway intervention	Cases without airway intervention during urgent endoscopy procedure for upper gastrointestinal bleeding
Endotracheal intubation	Endotracheal intubation	Cases with prophylactic endotracheal intubation during urgent endoscopy procedure for upper gastrointestinal bleeding .

Primary Outcome Measures

Name	Time	Method
Cardiovascular unplanned event	Postoperative up to 48 hours	The number of cardiovascular unplanned event after upper gastrointestinal endoscopy, up to 48 hours

Secondary Outcome Measures

Name	Time	Method
Pulmonary unplanned event	Postoperative up to 48 hours	The number of pulmonary unplanned event after upper gastrointestinal endoscopy, up to 48 hours.

Trial Locations

Locations (1)

Parkland Health Hospital System; 🇺🇸 Dallas, Texas, United States