Evaluation of Prophylactic Endotracheal Intubation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intubation;Difficult, Gastrointestinal Bleeding

Intervention / Treatment
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* Other: Endotracheal intubation
* Other: No airway intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endotracheal intubation<br>Cases with prophylactic endotracheal intubation during urgent endoscopy procedure for upper gastrointestinal bleeding . | Other: Endotracheal intubation<br>* Subjects will receive prophylactic endotracheal intubation for upper gastrointestinal endoscopy procedure<br>|
| No airway intervention<br>Cases without airway intervention during urgent endoscopy procedure for upper gastrointestinal bleeding | Other: No airway intervention<br>* Subjects without prophylactic endotracheal intubation during upper gastrointestinal endoscopy procedure<br>|

What is the study measuring?
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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 |