NCT00562146

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2007

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

October 28, 2008

Status Verified

October 1, 2008

Enrollment Period

9 months

First QC Date

November 20, 2007

Last Update Submit

October 27, 2008

Conditions

Acute Brain Injury

Keywords

nutritionenteral access

Study Arms (2)

1

Successful progression of spiral tube to duodenum within 3 days

Procedure: placement of spiral nasojejunal tube

2

Failure of progression to duodenum within 3 days

Procedure: placement of spiral nasojejunal tube

Interventions

placement of spiral nasojejunal tubePROCEDURE

spiral nasojejunal tube will be placed after enrollment of the patients

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Acute brain injured patients admitted to Neuro-ICU will be consecutively enrolled.

You may qualify if:

  • Acute brain injured patients admitted to Neuro-ICU

You may not qualify if:

  • Patients' stay in ICU shorter than 3 days
  • Patients with contraindication to naso-feeding tube placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Jian-Xin Zhou, MD

    ICU, Beijing Tiantan Hospital, Capital Medical University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 20, 2007

First Posted

November 21, 2007

Study Start

December 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

October 28, 2008

Record last verified: 2008-10

Locations

CN(1)