Clinical trial NCT03716466: Evaluation of Prophylactic Endotracheal Intubation
Official title: Evaluation of Prophylactic Endotracheal Intubation in the Patients With Upper Gastrointestinal Bleeding Undergoing Urgent Endoscopy: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation;Difficult
Gastrointestinal Bleeding
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases with upper gastrointestinal bleeding.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular unplanned event
timeFrame: Postoperative up to 48 hours
Secondary outcomes:
measure: Pulmonary unplanned event
timeFrame: Postoperative up to 48 hours
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health Hospital System
state: Texas
Study officials:
affiliation: 214-590-5352
name: David Nasir, MD
role: STUDY_DIRECTOR
References: