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

Liver Cirrhosis Clinical Trial

— NG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689754
• Other study ID #: 102007-022
• Status: Completed
• Phase: N/A
• First received: June 2, 2008
• Last updated: November 16, 2011
• Start date: January 2008
• Est. completion date: August 2011

Study information

• Verified date: November 2011
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Liver Cirrhosis

Intervention

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

Locations

Country	Name	City	State
United States	Parkland Memorial Hospital	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View Citation

Basuk PM, Isenberg JI. Gastric lavage in patients with gastrointestinal hemorrhage. Yea or nay? Arch Intern Med. 1990 Jul;150(7):1379-80. — View 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. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

Levy H. Nasogastric and nasoenteric feeding tubes. Gastrointest Endosc Clin N Am. 1998 Jul;8(3):529-49. Review. — View Citation

Luk GD, Bynum TE, Hendrix TR. Gastric aspiration in localization of gastrointestinal hemorrhage. JAMA. 1979 Feb 9;241(6):576-8. — View Citation

Peterson WL. Evaluation and initial management of patients with upper gastrointestinal bleeding. J Clin Gastroenterol. 1981;3(Suppl 2):79-84. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients predicted accurately to have a treatable lesion		24h	Yes
Secondary	Complications of nasogastric aspiration and lavage		24h	Yes
Secondary	Relationship between time to endoscopy and upper gastrointestinal hemorrhage		24h	Yes
Secondary	Relationship of nasogastric aspirate and lavage with number of units of packed reb blood cells transfused		24h	Yes
Secondary	Complication of nasogastric tube placement and aspiration in cirrhotics		24h	Yes

External Links

•   UT Southwestern website