Evaluation of Prophylactic Endotracheal Intubation

NCT03716466 | Completed

• 1 other identifier: STU 072018-045
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation;Difficult; Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (1)

• Cardiovascular unplanned event

  The number of cardiovascular unplanned event after upper gastrointestinal endoscopy, up to 48 hours

  Postoperative up to 48 hours

Secondary Outcomes (1)

• Pulmonary unplanned event

  Postoperative up to 48 hours

Study Arms (2)

Endotracheal intubation

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

Other: Endotracheal intubation

No airway intervention

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

Other: No airway intervention

Interventions

Endotracheal intubation OTHER

Subjects will receive prophylactic endotracheal intubation for upper gastrointestinal endoscopy procedure

Endotracheal intubation

No airway intervention OTHER

Subjects without prophylactic endotracheal intubation during upper gastrointestinal endoscopy procedure

No airway intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cases with upper gastrointestinal bleeding.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Health Hospital System

Dallas, Texas, 750390, United States

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Intubation, Intratracheal

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• David Nasir, MD

  214-590-5352

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOC PROFESSOR

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 23, 2018
• Study Start: November 11, 2018
• Primary Completion: December 6, 2018
• Study Completion: July 9, 2021
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)