Efficacy and Safety Study on Nasogastric (NG) Tube in Patients With Upper Gastrointestinal Bleed

Study Overview
=================
Brief Summary
-----------------
Upper gastrointestinal tract hemorrhage (UGIH) remains a major cause of morbidity and mortality . Nasogastric aspiration (NGA) is routinely performed in patients with UGIH to obtain important clinical data and make therapeutic decisions. But routine use of NGA remains controversial with studies reporting its usefulness and its redundant clinical information. Early esophagogastroduodenoscopy (EGD) is recommended by most gastrointestinal societies to allow for risk stratification and to perform endoscopic treatments. The results of the NGA may assist to differentiate between high-risk versus low-risk lesions. Our hypothesis is that presence of NGA can identify lesions that require endoscopic treatment and provides important clinical information to guide the treating physician. In addition, we hypothesized that the results of the NGA influence the clinical decision of the treating physician regarding the prediction of the need for endoscopic therapy. This observational randomized cross-sectional study will enroll consecutive patients with presumed UGIH and randomized them to NGA and no NGA recording its results. All patients will receive an EGD and its results will also be recorded. Subsequently, we will evaluate if the NGA is important in identifying endoscopically significant lesions. The information gained will help guide clinicians evaluating patient with UGIH.

Official Title
-----------------
The Role of Routine Placement of Nasogastric Tube in Patients With Suspected Upper Gastrointestinal Hemorrhage

Conditions
-----------------
Gastrointestinal Hemorrhage, Liver Cirrhosis

Intervention / Treatment
-----------------
* Procedure: nasogastric tube placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older then 21 years-old presenting with actual or reported: Hematemesis, Melena, or Hematemesis and Melena Exclusion Criteria: Refusal to participate Severe comorbid conditions making EGD hazardous for the patient, such as myocardial infarction < 3 months with the exception if the myocardial infarction was caused by the UGIH, hemorrhagic or ischemic stroke < 3 months, decompensated congestive heart failure, severe respiratory failure unless the patient is already intubated Survival expected to be less than 72h as judged by treating clinician Prisoners Patient with severe mental illness precluding the ability to obtain informed consent Ongoing anticoagulation which can not be reversed secondary to patient safety Strongly suspected gastrointestinal perforation Recent endoscopy (less than 30 days)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NGA<br>Patients will receive the standard of care to proceed with nasogastric tube placement, aspiration and lavage up to 1L of normal saline | Procedure: nasogastric tube placement<br>* standard nasogastric tube placement, aspiration and lavage up to 1L of normal saline<br>|
| No Intervention: NO NGA<br>Patient presenting with Upper GI hemorrhage going straight to endoscopy. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients predicted accurately to have a treatable lesion |  | 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of nasogastric aspiration and lavage |  | 24h | 
| Relationship between time to endoscopy and upper gastrointestinal hemorrhage |  | 24h | 
| Relationship of nasogastric aspirate and lavage with number of units of packed reb blood cells transfused |  | 24h | 
| Complication of nasogastric tube placement and aspiration in cirrhotics |  | 24h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastrointestinal hemorrhage, gastrointestinal intubation, endoscopy