Acute Brain InjuryNCT00562146
Rate of Postpyloric Migration of Spiral Nasojejunal Tubes in Brain Injured Patients
An observational study of Acute Brain Injury, run by Capital Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Brain Injury
- What is being tested?
- placement of spiral nasojejunal tube
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Dec 2007to Sep 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute brain injured patients admitted to Neuro-ICU will be consecutively enrolled.
Who may be able to join
- Acute brain injured patients admitted to Neuro-ICU
Who cannot join
- Patients' stay in ICU shorter than 3 days
- Patients with contraindication to naso-feeding tube placement
Trial locations and contacts
1 site in 1 country.
China1 site
ICU, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
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.
Read the 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.
- Conditions
- Acute Brain Injury
- Being tested
- placement of spiral nasojejunal tube
- Keywords
- nutrition, enteral access
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placement of spiral nasojejunal tubeProcedure or surgery
spiral nasojejunal tube will be placed after enrollment of the patients
| Study group | Role | What they receive |
|---|---|---|
| 1 | Successful progression of spiral tube to duodenum within 3 days Receives: Procedure: placement of spiral nasojejunal tube | |
| 2 | Failure of progression to duodenum within 3 days Receives: Procedure: placement of spiral nasojejunal tube |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Jian-Xin Zhou, MD, Study chair, ICU, Beijing Tiantan Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562146
- Sponsor's protocol ID
- BJTTH-ICU-07-011
- Other IDs
- BJTTH-ICU-07-011
- Status last verified
- Oct 2008
- First submitted
- 20 Nov 2007
- Last updated
- 28 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate of Postpyloric Migration of Spiral Nasojejunal Tubes in Brain Injured Patients
- ClinicalTrials.gov ID
- NCT00562146
- Acronym / sponsor ID
- BJTTH-ICU-07-011
- Conditions
- Acute Brain Injury
- Keywords
- nutrition, enteral access
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 21 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: placement of spiral nasojejunal tubeSuccessful progression of spiral tube to duodenum within 3 days |
| 2 | – | Procedure: placement of spiral nasojejunal tubeFailure of progression to duodenum within 3 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute brain injured patients admitted to Neuro-ICU will be consecutively enrolled.
Key inclusion criteria (1 listed)
- Acute brain injured patients admitted to Neuro-ICU
Key exclusion criteria (2 listed)
- Patients' stay in ICU shorter than 3 days
- Patients with contraindication to naso-feeding tube placement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placement of spiral nasojejunal tubespiral nasojejunal tube will be placed after enrollment of the patients | Procedure or surgery | 1, 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian-Xin Zhou, MD study chair
ICU, Beijing Tiantan Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Brain Injury, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2008.