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

This study has been completed.
Sponsor:
Information provided by:
Capital Medical University
ClinicalTrials.gov Identifier:
NCT00562146
First received: November 20, 2007
Last updated: October 27, 2008
Last verified: October 2008
History of Changes
  Purpose

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 Intervention
Acute Brain Injury
 Procedure: placement of spiral nasojejunal tube

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Rate of Postpyloric Migration of Spiral Nasojejunal Tubes in Brain Injured Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Capital Medical University:

Enrollment: 120
Study Start Date: December 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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, BJTTH-ICU-07-011
Study First Received: November 20, 2007
Last Updated: October 27, 2008
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on May 22, 2013