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Rate of Postpyloric Migration of Spiral Nasojejunal Tubes in Brain Injured Patients

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ClinicalTrials.gov Identifier: NCT00562146
Recruitment Status : Completed
First Posted : November 21, 2007
Last Update Posted : October 28, 2008
Sponsor:
Information provided by:
Capital Medical University

Study Description
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Brief Summary:
The success rate of unguided nasojejunal feeding tube insertion will be determined in acute brain injured patients. Factors influencing tube self-progression will be evaluated.

Condition or disease Intervention/treatment
Acute Brain Injury Procedure: placement of spiral nasojejunal tube

Detailed Description:

Nutrition support is important in brain injured patients. Several studies have shown that small bowel feeding compared with gastric feeding may be associated with a reduction in pneumonia in critically ill patients. The Canadian Clinical Practice Guidelines recommended that small bowel feedings should be considered for patients at high risk for intolerance to enteral nutrition.

There are several methods to place postpyloric tube, but there is a high success rate with endoscopic or radiological assistance. However, they are time consuming procedures, which is of limited availability at bedside and requires trained staff.

Nasojejunal tube with spiral end (Flocare Bengmark NJ tube) has been used for bedside placement for 10 years. But only limited data are available for success rate, especially in brain injured patients. The aim of this study is to access the success rate and influencing factors of spiral end nasojejunal tube in such a population.


Study Design
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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Rate of Postpyloric Migration of Spiral Nasojejunal Tubes in Brain Injured Patients
Study Start Date : December 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008
Groups and Cohorts
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Group/Cohort Intervention/treatment
1
Successful progression of spiral tube to duodenum within 3 days
 Procedure: placement of spiral nasojejunal tube
spiral nasojejunal tube will be placed after enrollment of the patients
2
Failure of progression to duodenum within 3 days
 Procedure: placement of spiral nasojejunal tube
spiral nasojejunal tube will be placed after enrollment of the patients


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Acute brain injured patients admitted to Neuro-ICU will be consecutively enrolled.
Criteria

Inclusion Criteria:

  • Acute brain injured patients admitted to Neuro-ICU

Exclusion Criteria:

  • Patients' stay in ICU shorter than 3 days
  • Patients with contraindication to naso-feeding tube placement
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562146


Locations
China, Beijing
ICU, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Capital Medical University
Investigators
Study Chair: Jian-Xin Zhou, MD ICU, Beijing Tiantan Hospital, Capital Medical University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Jian-Xin Zhou, ICU, Beijing Tiantan Hospital, Capital Medical University
ClinicalTrials.gov Identifier: NCT00562146     History of Changes
Other Study ID Numbers: BJTTH-ICU-07-011
First Posted: November 21, 2007    Key Record Dates
Last Update Posted: October 28, 2008
Last Verified: October 2008

Keywords provided by Capital Medical University:
nutrition
enteral access

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries