Gastrointestinal Bleeding, Intubation;Difficult
Conditions
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.
Interventions
OTHERNo airway intervention
Subjects without prophylactic endotracheal intubation during upper gastrointestinal endoscopy procedure
OTHEREndotracheal intubation
Subjects will receive prophylactic endotracheal intubation for upper gastrointestinal endoscopy procedure
Sponsors
University of Texas Southwestern Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular unplanned event | Postoperative up to 48 hours | The number of cardiovascular unplanned event after upper gastrointestinal endoscopy, up to 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary unplanned event | Postoperative up to 48 hours | The number of pulmonary unplanned event after upper gastrointestinal endoscopy, up to 48 hours. |
Countries
United States
Outcome results
None listed