Evaluation of Prophylactic Endotracheal Intubation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-11

Study Completion Date

2021-07-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tracheal Intubation and Prehospital Emergency Setting

NCT03486171

Tracheal Intubation Morbidity Emergency Medicine

UNKNOWN

Guidewire Use in Nasotracheal Intubation

NCT05937516

Epistaxis Nosebleed Pharyngeal Bleeding

COMPLETED NA

Real-time Sonography in Detecting Inadvertent Esophageal Intubation Among Difficult Intubation Patients

NCT05036460

Intubation; Difficult or Failed Intubation Complication Ultrasonography +1 more

UNKNOWN NA

Cuff Inflation-supplemented Videoscope-guided Nasal Intubation

NCT03136549

Nasotracheal Intubation

COMPLETED NA

Determining the Effects of Foley Catheter-assisted Nasal Intubation on Nasal Bleeding in Adult Patients

NCT05072392

Nasal Bleeding

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intubation;Difficult Gastrointestinal Bleeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Endotracheal intubation

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

Endotracheal intubation

Intervention Type OTHER

Subjects will receive prophylactic endotracheal intubation for upper gastrointestinal endoscopy procedure

No airway intervention

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

No airway intervention

Intervention Type OTHER

Subjects without prophylactic endotracheal intubation during upper gastrointestinal endoscopy procedure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endotracheal intubation

Subjects will receive prophylactic endotracheal intubation for upper gastrointestinal endoscopy procedure

Intervention Type OTHER

No airway intervention

Subjects without prophylactic endotracheal intubation during upper gastrointestinal endoscopy procedure

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No