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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: University of Texas Southwestern Medical Center

Current Primary Outcome: The number of patients predicted accurately to have a treatable lesion [ Time Frame: 24h ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Complications of nasogastric aspiration and lavage [ Time Frame: 24h ]
  • Relationship between time to endoscopy and upper gastrointestinal hemorrhage [ Time Frame: 24h ]
  • Relationship of nasogastric aspirate and lavage with number of units of packed reb blood cells transfused [ Time Frame: 24h ]
  • Complication of nasogastric tube placement and aspiration in cirrhotics [ Time Frame: 24h ]


Original Secondary Outcome: Same as current

Information By: University of Texas Southwestern Medical Center

Dates:
Date Received: June 2, 2008
Date Started: January 2008
Date Completion:
Last Updated: November 16, 2011
Last Verified: November 2011