Critically IllNCT00807287
Evaluation of Two Methods of Jejunal Placement of Enteral Feeding Tubes in Critically Ill Patients
A study testing Jejunal tube placement using the unguided frictional method and Jejunal tube placement using the endoscopic method in people with Critically Ill, run by Medical University of Vienna at 1 site in Austria.
Trial summary
In patients with high gastric residual volumes jejunal feeding is recommended. Jejunal feeding tubes can be placed in different ways. The endoscopic technique yields a success rate between 90 and 98% for a correct jejunal placement. However, it requires endoscopic equipment and trained staff. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- Jejunal tube placement using the unguided frictional method and Jejunal tube placement using the endoscopic method
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2005to Apr 2006
- 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
- Intubated and mechanically ventilated
- Intolerance of intragastric enteral nutrition: defined as high gastric residual volumes (≥ 250ml / 24 hours) and/or repeated vomiting.
Who cannot join
- Contraindication for enteral nutrition or gastric endoscopy
- Previous upper gastrointestinal surgery
- Signs of active gastric bleeding
- Severe nasopharyngeal injuries or stenosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Two Methods of Jejunal Placement of Enteral Feeding Tubes in Critically Ill Patients: Endoscopic Versus Unguided, Frictional Method
In patients with high gastric residual volumes jejunal feeding is recommended. Jejunal feeding tubes can be placed in different ways. The endoscopic technique yields a success rate between 90 and 98% for a correct jejunal placement. However, it requires endoscopic equipment and trained staff. In contrast in small uncontrolled trials different unguided techniques resulted in success rates up to 75%, only. In this prospective randomized trial the success rate of a correct jejunal placement with the endoscopic technique is compared with the unguided frictional technique. The investigators hypothesize that the success rate of the unguided frictional placement method will be lower than the success rate of the endoscopic method.
Read the detailed description
Artificial nutrition is an important link between the response to injury and recovery in critically ill patients admitted to an intensive care unit (ICU) Therefore artificial nutrition has become a part of ICU standard-therapy.
Enteral nutrition (EN) has shown to be superior to total parenteral nutrition. Consequently, EN should be first choice in patients without contraindications for enteral feeding. However, although EN is beneficial for the patient it may also be associated with complications because of gastroduodenal motility disorders, which are common in critically ill patients, especially when they receive analgosedation.
Clinical studies have shown that up to 62,8% of patients receiving EN have gastrointestinal complications like high gastric residuals (≥200ml), vomiting, abdominal distension and regurgitation. These complications lead to interruptions of the EN, which result in a low caloric intake of the patient.
In order to avoid at least some of these complications the American Society of Chest Physicians consensus statement recommends small bowel feeding if gastric residual volumes of 150ml or higher occur. The Canadian clinical practice guidelines recommend acceptance of gastric residual volumes up to 250 ml, use of prokinetic agents and jejunal feeding for patient, who are at high risk for intolerance of EN (on inotropes, sedatives, paralytic agents.
Small bowel feeding is the best method to feed the patient enterally because it is associated with a significant decrease of reflux, a reduced risk of aspiration and an adequate caloric intake.
For small bowel feeding the placement of a jejunal feeding tube is necessary. There are several possibilities to place the tube in the small bowel. An excellent method is endoscopy, which has a success rate up to 98% and moreover allows an evaluation of the upper GI-tract concerning pathologies. However it is a rather time consuming procedure, which is of limited availability and requires trained staff. As more simple alternatives unguided tubes, which place themselves in the small bowel were tested and showed success rates up to 75% only. Different patient population and different severity of illness in ICU patients mislead to this developed difference in success rate.
So far a prospective randomised trial comparing the endoscopic method versus the unguided frictional placement has not been studied. Therefore the aim of the study is the evaluation of the success rate of jejunal placement of these two different methods in a comparative ICU patient population. The secondary outcome parameters are: time to successful placement, time in place, costs and complications. We hypothesize that the success rate of the unguided frictional placement method will be lower than the success rate of the endoscopic method.
- Conditions
- Critically Ill
- Being tested
- Jejunal tube placement using the unguided frictional method, Jejunal tube placement using the endoscopic method
- Keywords
- jejunal tube placement
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jejunal tube placement using the unguided frictional methodProcedure or surgery
Also called Tiger Tube TM (Cook® Medical Inc., Bloomington, USA)
The self-advancing nasal jejunal feeding tube has small alternating cilia-like plastic flaps to help to advance it into the small bowel via peristalsis. The tube is placed in the stomach (50-60 cm mark). Then the tube is left in place for 1 hour to allow the patient's peristalsis to advance the tube by catching its small plastic tabs. Thereafter, the tube is manually advanced 10 cm every hour until the 100 cm mark of length is reached. To improve peristalsis, 10mg metoclopramide i.v. and 200mg erythromycin i.v. 15 minutes before the procedure are administered.
Jejunal tube placement using the endoscopic methodProcedure or surgery
Also called Freka® Trelumina (Fresenius Kabi AG, Bad Homburg, Germany)
Jejunal feeding tubes are placed using endoscopy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Placement of jejunal feeding tube using the unguided frictional method Receives: Procedure: Jejunal tube placement using the unguided frictional method |
| 2 | Active comparator | Jejunal tube placement using the endoscopic method Receives: Procedure: Jejunal tube placement using the endoscopic method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of correct jejunal placement
Measured: 24h
Secondary outcomes (2)
Duration of jejunal tube placement (initiation of jejunal tube placement till correct jejunal placement
Measured: 24h
Adverse effects of tube placement and adverse side effects of jejunal tubes during the ICU stay
Measured: ICU-stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startFeb 2005
- Primary completionFeb 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Ulrike Holzinger, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807287
- Sponsor's protocol ID
- 517/2004
- Status last verified
- Dec 2008
- First submitted
- 10 Dec 2008
- Last updated
- 11 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Methods of Jejunal Placement of Enteral Feeding Tubes in Critically Ill Patients: Endoscopic Versus Unguided, Frictional Method
- ClinicalTrials.gov ID
- NCT00807287
- Acronym / sponsor ID
- 517/2004
- Conditions
- Critically Ill
- Keywords
- jejunal tube placement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 11 Dec 2008 (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.
In patients with high gastric residual volumes jejunal feeding is recommended. Jejunal feeding tubes can be placed in different ways. The endoscopic technique yields a success rate between 90 and 98% for a correct jejunal placement. However, it requires endoscopic equipment and trained staff. In contrast in small uncontrolled trials different unguided techniques resulted in success rates up to 75%, only. In this prospective randomized trial the success rate of a correct jejunal placement with the endoscopic technique is compared with the unguided frictional technique. The investigators hypothesize that the success rate of the unguided frictional placement method will be lower than the success rate of the endoscopic method.
Detailed description
Artificial nutrition is an important link between the response to injury and recovery in critically ill patients admitted to an intensive care unit (ICU) Therefore artificial nutrition has become a part of ICU standard-therapy.
Enteral nutrition (EN) has shown to be superior to total parenteral nutrition. Consequently, EN should be first choice in patients without contraindications for enteral feeding. However, although EN is beneficial for the patient it may also be associated with complications because of gastroduodenal motility disorders, which are common in critically ill patients, especially when they receive analgosedation.
Clinical studies have shown that up to 62,8% of patients receiving EN have gastrointestinal complications like high gastric residuals (≥200ml), vomiting, abdominal distension and regurgitation. These complications lead to interruptions of the EN, which result in a low caloric intake of the patient.
In order to avoid at least some of these complications the American Society of Chest Physicians consensus statement recommends small bowel feeding if gastric residual volumes of 150ml or higher occur. The Canadian clinical practice guidelines recommend acceptance of gastric residual volumes up to 250 ml, use of prokinetic agents and jejunal feeding for patient, who are at high risk for intolerance of EN (on inotropes, sedatives, paralytic agents.
Small bowel feeding is the best method to feed the patient enterally because it is associated with a significant decrease of reflux, a reduced risk of aspiration and an adequate caloric intake.
For small bowel feeding the placement of a jejunal feeding tube is necessary. There are several possibilities to place the tube in the small bowel. An excellent method is endoscopy, which has a success rate up to 98% and moreover allows an evaluation of the upper GI-tract concerning pathologies. However it is a rather time consuming procedure, which is of limited availability and requires trained staff. As more simple alternatives unguided tubes, which place themselves in the small bowel were tested and showed success rates up to 75% only. Different patient population and different severity of illness in ICU patients mislead to this developed difference in success rate.
So far a prospective randomised trial comparing the endoscopic method versus the unguided frictional placement has not been studied. Therefore the aim of the study is the evaluation of the success rate of jejunal placement of these two different methods in a comparative ICU patient population. The secondary outcome parameters are: time to successful placement, time in place, costs and complications. We hypothesize that the success rate of the unguided frictional placement method will be lower than the success rate of the endoscopic method.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Jejunal tube placement using the unguided frictional methodPlacement of jejunal feeding tube using the unguided frictional method |
| 2 | Active comparator | Procedure: Jejunal tube placement using the endoscopic methodJejunal tube placement using the endoscopic method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Intubated and mechanically ventilated
- Intolerance of intragastric enteral nutrition: defined as high gastric residual volumes (≥ 250ml / 24 hours) and/or repeated vomiting.
Key exclusion criteria (4 listed)
- Contraindication for enteral nutrition or gastric endoscopy
- Previous upper gastrointestinal surgery
- Signs of active gastric bleeding
- Severe nasopharyngeal injuries or stenosis
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 |
|---|---|---|
| Jejunal tube placement using the unguided frictional methodAlso: Tiger Tube TM (Cook® Medical Inc., Bloomington, USA)The self-advancing nasal jejunal feeding tube has small alternating cilia-like plastic flaps to help to advance it into the small bowel via peristalsis. The tube is placed in the stomach (50-60 cm mark). Then the tube is left in place for 1 hour to allow the patient's peristalsis to advance the tube by catching its small plastic tabs. Thereafter, the tube is manually advanced 10 cm every hour until the 100 cm mark of length is reached. To improve peristalsis, 10mg metoclopramide i.v. and 200mg erythromycin i.v. 15 minutes before the procedure are administered. | Procedure or surgery | 1 |
| Jejunal tube placement using the endoscopic methodAlso: Freka® Trelumina (Fresenius Kabi AG, Bad Homburg, Germany)Jejunal feeding tubes are placed using endoscopy | Procedure or surgery | 2 |
Primary outcome
Success rate of correct jejunal placement
Time frame: 24h
2 secondary outcomes
Duration of jejunal tube placement (initiation of jejunal tube placement till correct jejunal placement
Time frame: 24h
Adverse effects of tube placement and adverse side effects of jejunal tubes during the ICU stay
Time frame: ICU-stay
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 11 Dec 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.
Ulrike Holzinger, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jejunal tube placement using the unguided frictional method and Jejunal tube placement using the endoscopic method in people with Critically Ill, run by Medical University of Vienna at 1 site in Austria.
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 2 inclusion and 4 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 11 Dec 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 Austria. 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 rate of correct jejunal placement (time frame: 24h). 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 11 Dec 2008.