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

Completed · Not applicable

Conditions studied: Gastrointestinal Hemorrhage, Liver Cirrhosis

In brief

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.

Key facts

Study ID

NCT00689754

Run by

University of Texas Southwestern Medical Center

People needed

282

Starts

2008-01-01

Expected to finish

2011-08-01

Last updated by the study team

2011-11-18

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients older then 21 years-old presenting with actual or reported: Hematemesis, Melena, or Hematemesis and Melena

You may not qualify if…

• 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)

Where it is running

• Parkland Memorial Hospital — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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