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Evaluation of Prophylactic Endotracheal Intubation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716466
Recruitment Status : Suspended (Suspended due to covid-19 policy)
First Posted : October 23, 2018
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment
Intubation;Difficult Gastrointestinal Bleeding Other: Endotracheal intubation Other: No airway intervention

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Endotracheal intubation
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




Primary Outcome Measures :
  1. Cardiovascular unplanned event [ Time Frame: Postoperative up to 48 hours ]
    The number of cardiovascular unplanned event after upper gastrointestinal endoscopy, up to 48 hours


Secondary Outcome Measures :
  1. Pulmonary unplanned event [ Time Frame: Postoperative up to 48 hours ]
    The number of pulmonary unplanned event after upper gastrointestinal endoscopy, up to 48 hours.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Cases with upper gastrointestinal bleeding.
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Texas
Parkland Health Hospital System
Dallas, Texas, United States, 750390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Study Director: Seema Dave, MPH 214-648-4756
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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03716466    
Other Study ID Numbers: STU 072018-045
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases