no Primary Disease; ICU Patient Who Require Enteral NutritionNCT00245687
A Research Study to Test (2) Two Different Types of Feeding Tubes Used in the Intensive Care Unit
A study testing Tiger Tube in people with no Primary Disease; ICU Patient Who Require Enteral Nutrition, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The purpose of this study is to compare the success rates of two types of feeding tubes, specifically the standard gastric feeding tube to a small bowel feeding tube. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- no Primary Disease; ICU Patient Who Require Enteral Nutrition
- What is being tested?
- Tiger Tube
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jun 2007
- Phase
- Interventional
- 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
Who may be able to join
- all ICU patients requiring enteral nutrition
Who cannot join
- coagulopathy, esophageal or gastric, surgery, varices, trauma, ulcer, structure, rupture
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital - MRICU
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Comparative Study of the Tiger Tube Frictional Nasal Jejunal Feeding Tube and the Dubhoff Tube
The purpose of this study is to compare the success rates of two types of feeding tubes, specifically the standard gastric feeding tube to a small bowel feeding tube.
Read the detailed description
Enteral nutrition has many advantages for critically ill patients including lower incidence of infections and a reduced hospital stay, however it is controversial whether enteral feeding via small bowel feeding tubes offers an advantage over gastric feeding tubes in terms of reducing aspiration risk, improving feeding tolerance or ensuring quicker attainment of nutritional goals. The advantages of a small bowel feeding tube over a gastric feeding tube is thought to be related to its post pyloric position, however the insertion of small bowel feeding tubes is technically challenging (most studies report a success rate of 15-30%), can take time and has complications not unlike those of the gastric feeding tube. Our hypothesis is that the small bowel feeding tube offers an advantage to the gastric feeding tube due to its ability to achieve post pyloric placement. Specifically we chose to compare the standard gastric feeding tube (Dubhoff) to a small bowel feeding tube which offers the advantage of having alternating flaps which allows the gut to drag this tube into the small bowel.
- Being tested
- Tiger Tube
- Keywords
- feeding tube, nutrition, gastric, jejunal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiger TubeDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
success in placing feeding tube
Secondary outcomes (1)
- rate of reaching nutritional goal, aspiration pneumonia, feeding tolerance, and pre-albumin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startJun 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for no Primary Disease; ICU Patient Who Require Enteral NutritionStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Investigators
- Paul Marik, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245687
- Sponsor's protocol ID
- 05U.229
- Status last verified
- Mar 2014
- First submitted
- 26 Oct 2005
- Last updated
- 14 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Tiger Tube Frictional Nasal Jejunal Feeding Tube and the Dubhoff Tube
- ClinicalTrials.gov ID
- NCT00245687
- Acronym / sponsor ID
- 05U.229
- Keywords
- feeding tube, nutrition, gastric, jejunal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 28 Oct 2005 (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 purpose of this study is to compare the success rates of two types of feeding tubes, specifically the standard gastric feeding tube to a small bowel feeding tube.
Detailed description
Enteral nutrition has many advantages for critically ill patients including lower incidence of infections and a reduced hospital stay, however it is controversial whether enteral feeding via small bowel feeding tubes offers an advantage over gastric feeding tubes in terms of reducing aspiration risk, improving feeding tolerance or ensuring quicker attainment of nutritional goals. The advantages of a small bowel feeding tube over a gastric feeding tube is thought to be related to its post pyloric position, however the insertion of small bowel feeding tubes is technically challenging (most studies report a success rate of 15-30%), can take time and has complications not unlike those of the gastric feeding tube. Our hypothesis is that the small bowel feeding tube offers an advantage to the gastric feeding tube due to its ability to achieve post pyloric placement. Specifically we chose to compare the standard gastric feeding tube (Dubhoff) to a small bowel feeding tube which offers the advantage of having alternating flaps which allows the gut to drag this tube into the small bowel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all ICU patients requiring enteral nutrition
Key exclusion criteria (1 listed)
- coagulopathy, esophageal or gastric, surgery, varices, trauma, ulcer, structure, rupture
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 |
|---|---|---|
| Tiger Tube | Device | – |
Primary outcome
success in placing feeding tube
1 secondary outcome
- rate of reaching nutritional goal, aspiration pneumonia, feeding tolerance, and pre-albumin
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 14 Mar 2014.
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.
Paul Marik, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tiger Tube in people with no Primary Disease; ICU Patient Who Require Enteral Nutrition, run by Thomas Jefferson University at 1 site in United States.
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 1 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 14 Mar 2014. 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 United States. 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.
What does the primary outcome measure?
success in placing feeding tube. It is what the study was designed to measure, not a finding.
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 14 Mar 2014.