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

Primary Purpose

Gastrointestinal Hemorrhage, Liver Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
nasogastric tube placement
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastrointestinal Hemorrhage focused on measuring gastrointestinal hemorrhage, gastrointestinal intubation, endoscopy

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Parkland Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

NGA

NO NGA

Arm Description

Patients will receive the standard of care to proceed with nasogastric tube placement, aspiration and lavage up to 1L of normal saline

Patient presenting with Upper GI hemorrhage going straight to endoscopy.

Outcomes

Primary Outcome Measures

The number of patients predicted accurately to have a treatable lesion

Secondary Outcome Measures

Complications of nasogastric aspiration and lavage
Relationship between time to endoscopy and upper gastrointestinal hemorrhage
Relationship of nasogastric aspirate and lavage with number of units of packed reb blood cells transfused
Complication of nasogastric tube placement and aspiration in cirrhotics

Full Information

First Posted
June 2, 2008
Last Updated
November 16, 2011
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00689754
Brief Title
Efficacy and Safety Study on Nasogastric (NG) Tube in Patients With Upper Gastrointestinal Bleed
Acronym
NG
Official Title
The Role of Routine Placement of Nasogastric Tube in Patients With Suspected Upper Gastrointestinal Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Hemorrhage, Liver Cirrhosis
Keywords
gastrointestinal hemorrhage, gastrointestinal intubation, endoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
282 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NGA
Arm Type
Active Comparator
Arm Description
Patients will receive the standard of care to proceed with nasogastric tube placement, aspiration and lavage up to 1L of normal saline
Arm Title
NO NGA
Arm Type
No Intervention
Arm Description
Patient presenting with Upper GI hemorrhage going straight to endoscopy.
Intervention Type
Procedure
Intervention Name(s)
nasogastric tube placement
Intervention Description
standard nasogastric tube placement, aspiration and lavage up to 1L of normal saline
Primary Outcome Measure Information:
Title
The number of patients predicted accurately to have a treatable lesion
Time Frame
24h
Secondary Outcome Measure Information:
Title
Complications of nasogastric aspiration and lavage
Time Frame
24h
Title
Relationship between time to endoscopy and upper gastrointestinal hemorrhage
Time Frame
24h
Title
Relationship of nasogastric aspirate and lavage with number of units of packed reb blood cells transfused
Time Frame
24h
Title
Complication of nasogastric tube placement and aspiration in cirrhotics
Time Frame
24h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvio W Melo, MD
Organizational Affiliation
UT Southwestern Medical Center at Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
310892
Citation
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Results Reference
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Citation
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PubMed Identifier
6971777
Citation
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.
Results Reference
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PubMed Identifier
2196022
Citation
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Results Reference
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PubMed Identifier
2369238
Citation
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PubMed Identifier
1556428
Citation
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.
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PubMed Identifier
9654567
Citation
Levy H. Nasogastric and nasoenteric feeding tubes. Gastrointest Endosc Clin N Am. 1998 Jul;8(3):529-49.
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PubMed Identifier
14623622
Citation
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.
Results Reference
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PubMed Identifier
14745388
Citation
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.
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PubMed Identifier
15492601
Citation
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.
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PubMed Identifier
16240216
Citation
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.
Results Reference
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PubMed Identifier
28069629
Citation
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.
Results Reference
derived
Links:
URL
http://www.utsouthwestern.edu
Description
UT Southwestern website

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

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