Evaluation of Prophylactic Endotracheal Intubation
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|ClinicalTrials.gov Identifier: NCT03716466|
Recruitment Status : Suspended (Suspended due to covid-19 policy)
First Posted : October 23, 2018
Last Update Posted : May 21, 2020
|Condition or disease||Intervention/treatment|
|Intubation;Difficult Gastrointestinal Bleeding||Other: Endotracheal intubation Other: No airway intervention|
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.
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Evaluation of Prophylactic Endotracheal Intubation in the Patients With Upper Gastrointestinal Bleeding Undergoing Urgent Endoscopy: A Prospective Observational Study|
|Actual Study Start Date :||October 4, 2018|
|Estimated Primary Completion Date :||April 15, 2021|
|Estimated Study Completion Date :||October 1, 2021|
Cases with prophylactic endotracheal intubation during urgent endoscopy procedure for upper gastrointestinal bleeding .
Other: Endotracheal intubation
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
Other: No airway intervention
Subjects without prophylactic endotracheal intubation during upper gastrointestinal endoscopy procedure
- Cardiovascular unplanned event [ Time Frame: Postoperative up to 48 hours ]The number of cardiovascular unplanned event after upper gastrointestinal endoscopy, up to 48 hours
- Pulmonary unplanned event [ Time Frame: Postoperative up to 48 hours ]The number of pulmonary unplanned event after upper gastrointestinal endoscopy, up to 48 hours.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716466
|United States, Texas|
|Parkland Health Hospital System|
|Dallas, Texas, United States, 750390|
|Study Director:||Seema Dave, MPH||214-648-4756|