Evaluation of Prophylactic Endotracheal Intubation

Intubation;Difficult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03716466
• Other study ID #: STU 072018-045
• Status: Completed
• Start date: November 11, 2018
• Est. completion date: July 9, 2021

Study information

• Verified date: May 2022
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: July 9, 2021
• Est. primary completion date: December 6, 2018
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage
• Intubation;Difficult

Intervention

Other:
• Endotracheal intubation
Subjects will receive prophylactic endotracheal intubation for upper gastrointestinal endoscopy procedure
• No airway intervention
Subjects without prophylactic endotracheal intubation during upper gastrointestinal endoscopy procedure

Locations

Country	Name	City	State
United States	Parkland Health Hospital System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular unplanned event	The number of cardiovascular unplanned event after upper gastrointestinal endoscopy, up to 48 hours	Postoperative up to 48 hours
Secondary	Pulmonary unplanned event	The number of pulmonary unplanned event after upper gastrointestinal endoscopy, up to 48 hours.	Postoperative up to 48 hours