- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03716466
Evaluation of Prophylactic Endotracheal Intubation
Evaluation of Prophylactic Endotracheal Intubation in the Patients With Upper Gastrointestinal Bleeding Undergoing Urgent Endoscopy: A Prospective Observational Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Texas
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Dallas, Texas, United States, 750390
- Parkland Health Hospital System
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Endotracheal intubation
Cases with prophylactic endotracheal intubation during urgent endoscopy procedure for upper gastrointestinal bleeding .
|
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
|
Subjects without prophylactic endotracheal intubation during upper gastrointestinal endoscopy procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular unplanned event
Time Frame: Postoperative up to 48 hours
|
The number of cardiovascular unplanned event after upper gastrointestinal endoscopy, up to 48 hours
|
Postoperative up to 48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulmonary unplanned event
Time Frame: Postoperative up to 48 hours
|
The number of pulmonary unplanned event after upper gastrointestinal endoscopy, up to 48 hours.
|
Postoperative up to 48 hours
|
Collaborators and Investigators
Investigators
- Study Director: David Nasir, MD, 214-590-5352
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU 072018-045
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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