Evaluation of Prophylactic Endotracheal Intubation
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 12/21/2018 |
| Start Date: | October 4, 2018 |
| End Date: | October 1, 2019 |
| Contact: | Dawood Nasir, MD |
| Email: | Dawood.Nasir@UTSouthwestern.edu |
| Phone: | 214-590-5352 |
Evaluation of Prophylactic Endotracheal Intubation in the Patients With Upper Gastrointestinal Bleeding Undergoing Urgent Endoscopy: A Prospective Observational Study
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 compare the incidence of
complications among critically ill patients with upper GI bleeding and received urgent
endoscopy.
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 compare the incidence of
complications among critically ill patients with upper GI bleeding and received urgent
endoscopy.
This is a prospective observational study. After Institutional Review Board (IRB) approval,
consecutive patient with upper gastrointestinal (GI) bleeding and undergoing urgent endoscopy
will be enrolled to the study by anesthesia providers over 6-months period. Eligible patients
will be identified when presented GI suite for urgent upper GI endoscopy.
Prospective data will be collected for the first 48 hours during hospital stay by reviewing
medical record. Immediate complications, complications for first 24 hours and complications
for 48 hours will be prospectively collected. All data points will be collected from
electronic medical record and entered to encrypted Excel spreadsheet and then will be secured
in RedCap data base.
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.
consecutive patient with upper gastrointestinal (GI) bleeding and undergoing urgent endoscopy
will be enrolled to the study by anesthesia providers over 6-months period. Eligible patients
will be identified when presented GI suite for urgent upper GI endoscopy.
Prospective data will be collected for the first 48 hours during hospital stay by reviewing
medical record. Immediate complications, complications for first 24 hours and complications
for 48 hours will be prospectively collected. All data points will be collected from
electronic medical record and entered to encrypted Excel spreadsheet and then will be secured
in RedCap data base.
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.
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
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