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Clinical Trials/NCT00689754
NCT00689754CompletedNot Applicable

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

University of Texas Southwestern Medical Center2 sites in 1 country282 target enrollmentStarted: January 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
282
Locations
2
Primary Endpoint
The number of patients predicted accurately to have a treatable lesion

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

The number of patients predicted accurately to have a treatable lesion

Time Frame: 24h

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Silvio Melo

MD

University of Texas Southwestern Medical Center

Study Sites (2)

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