Efficacy and Safety Study on Nasogastric (NG) Tube in Patients With Upper Gastrointestinal Bleed
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Gastrointestinal Hemorrhage Liver Cirrhosis |
Procedure: nasogastric tube placement |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | The Role of Routine Placement of Nasogastric Tube in Patients With Suspected Upper Gastrointestinal Hemorrhage |
- The number of patients predicted accurately to have a treatable lesion [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
- Complications of nasogastric aspiration and lavage [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
- Relationship between time to endoscopy and upper gastrointestinal hemorrhage [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
- Relationship of nasogastric aspirate and lavage with number of units of packed reb blood cells transfused [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
- Complication of nasogastric tube placement and aspiration in cirrhotics [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
| Enrollment: | 282 |
| Study Start Date: | January 2008 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Procedure: nasogastric tube placement
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.
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| 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)
Contacts and Locations| United States, Texas | |
| Parkland Memorial Hospital | |
| Dallas, Texas, United States, 75235 | |
| Principal Investigator: | Silvio W Melo, MD | UT Southwestern Medical Center at Dallas |
More Information
Additional Information:
Publications:
| Responsible Party: | Silvio Melo, MD, University of Texas Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT00689754 History of Changes |
| Other Study ID Numbers: | 102007-022 |
| Study First Received: | June 2, 2008 |
| Last Updated: | November 16, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Texas Southwestern Medical Center:
|
gastrointestinal hemorrhage gastrointestinal intubation endoscopy |
Additional relevant MeSH terms:
|
Gastrointestinal Hemorrhage Hemorrhage Liver Cirrhosis Fibrosis |
Gastrointestinal Diseases Digestive System Diseases Pathologic Processes Liver Diseases |
ClinicalTrials.gov processed this record on June 18, 2013