- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00689754
Efficacy and Safety Study on Nasogastric (NG) Tube in Patients With Upper Gastrointestinal Bleed (NG)
November 16, 2011 updated by: Silvio Melo, University of Texas Southwestern Medical Center
The Role of Routine Placement of Nasogastric Tube in Patients With Suspected Upper Gastrointestinal Hemorrhage
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
282
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75235
- Parkland Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: NGA
Patients will receive the standard of care to proceed with nasogastric tube placement, aspiration and lavage up to 1L of normal saline
|
standard nasogastric tube placement, aspiration and lavage up to 1L of normal saline
|
No Intervention: NO NGA
Patient presenting with Upper GI hemorrhage going straight to endoscopy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of patients predicted accurately to have a treatable lesion
Time Frame: 24h
|
24h
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complications of nasogastric aspiration and lavage
Time Frame: 24h
|
24h
|
Relationship between time to endoscopy and upper gastrointestinal hemorrhage
Time Frame: 24h
|
24h
|
Relationship of nasogastric aspirate and lavage with number of units of packed reb blood cells transfused
Time Frame: 24h
|
24h
|
Complication of nasogastric tube placement and aspiration in cirrhotics
Time Frame: 24h
|
24h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Silvio W Melo, MD, Ut Southwestern Medical Center At Dallas
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Luk GD, Bynum TE, Hendrix TR. Gastric aspiration in localization of gastrointestinal hemorrhage. JAMA. 1979 Feb 9;241(6):576-8.
- Peterson WL. Evaluation and initial management of patients with upper gastrointestinal bleeding. J Clin Gastroenterol. 1981;3(Suppl 2):79-84.
- Gilbert DA, Silverstein FE, Tedesco FJ, Buenger NK, Persing J. The national ASGE survey on upper gastrointestinal bleeding. III. Endoscopy in upper gastrointestinal bleeding. Gastrointest Endosc. 1981 May;27(2):94-102. doi: 10.1016/s0016-5107(81)73157-2. No abstract available.
- Cuellar RE, Gavaler JS, Alexander JA, Brouillette DE, Chien MC, Yoo YK, Rabinovitz M, Stone BG, Van Thiel DH. Gastrointestinal tract hemorrhage. The value of a nasogastric aspirate. Arch Intern Med. 1990 Jul;150(7):1381-4. doi: 10.1001/archinte.150.7.1381.
- Basuk PM, Isenberg JI. Gastric lavage in patients with gastrointestinal hemorrhage. Yea or nay? Arch Intern Med. 1990 Jul;150(7):1379-80. No abstract available.
- Cappell MS, Scarpa PJ, Nadler S, Miller SH. Complications of nasoenteral tubes. Intragastric tube knotting and intragastric tube breakage. J Clin Gastroenterol. 1992 Mar;14(2):144-7. doi: 10.1097/00004836-199203000-00015.
- Levy H. Nasogastric and nasoenteric feeding tubes. Gastrointest Endosc Clin N Am. 1998 Jul;8(3):529-49.
- Barkun A, Bardou M, Marshall JK; Nonvariceal Upper GI Bleeding Consensus Conference Group. Consensus recommendations for managing patients with nonvariceal upper gastrointestinal bleeding. Ann Intern Med. 2003 Nov 18;139(10):843-57. doi: 10.7326/0003-4819-139-10-200311180-00012.
- Aljebreen AM, Fallone CA, Barkun AN. Nasogastric aspirate predicts high-risk endoscopic lesions in patients with acute upper-GI bleeding. Gastrointest Endosc. 2004 Feb;59(2):172-8. doi: 10.1016/s0016-5107(03)02543-4.
- Lee SD, Kearney DJ. A randomized controlled trial of gastric lavage prior to endoscopy for acute upper gastrointestinal bleeding. J Clin Gastroenterol. 2004 Nov-Dec;38(10):861-5. doi: 10.1097/00004836-200411000-00005.
- Cappell MS. Safety and efficacy of nasogastric intubation for gastrointestinal bleeding after myocardial infarction: an analysis of 125 patients at two tertiary cardiac referral hospitals. Dig Dis Sci. 2005 Nov;50(11):2063-70. doi: 10.1007/s10620-005-3008-8.
- Rockey DC, Ahn C, de Melo SW Jr. Randomized pragmatic trial of nasogastric tube placement in patients with upper gastrointestinal tract bleeding. J Investig Med. 2017 Apr;65(4):759-764. doi: 10.1136/jim-2016-000375. Epub 2017 Jan 9.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
June 2, 2008
First Submitted That Met QC Criteria
June 3, 2008
First Posted (Estimate)
June 4, 2008
Study Record Updates
Last Update Posted (Estimate)
November 18, 2011
Last Update Submitted That Met QC Criteria
November 16, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102007-022
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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