Evaluation of Prophylactic Endotracheal Intubation

The University of Texas System (UT)

Status: Completed

Conditions: Intubation;Difficult; Gastrointestinal Bleeding

Treatments: Other: Endotracheal intubation; Other: No airway intervention

Study type: Observational

Funder types: Other

Identifiers

NCT03716466

STU 072018-045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

65 participants in 2 patient groups

Endotracheal intubation

Description:

Cases with prophylactic endotracheal intubation during urgent endoscopy procedure for upper gastrointestinal bleeding .

Treatment:

Other: Endotracheal intubation

No airway intervention

Description:

Cases without airway intervention during urgent endoscopy procedure for upper gastrointestinal bleeding

Treatment:

Other: No airway intervention