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

NCT00689754 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2011-11-18

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

nasogastric tube placement

standard nasogastric tube placement, aspiration and lavage up to 1L of normal saline

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Silvio W Melo, MD · UT Southwestern Medical Center at Dallas

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00689754 on ClinicalTrials.gov