Critical IllnessNCT00500851
Evaluation of Jejunal Placement of Enteral Feeding Tubes
A study testing Electromagnetic imaging for jejunal tube placement (CORTRAK) and Endoscopy in people with Critical Illness and Tube Feeding, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this study is the evaluation of the success rate of jejunal tube placement comparing the endoscopic versus the electromagnetic method in a comparative ICU patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Tube Feeding
- What is being tested?
- Electromagnetic imaging for jejunal tube placement (CORTRAK) and Endoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteAustria
- Study dates
- May 2007to Feb 2009
- 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
- Intolerance of intragastric feeding (high gastric residual volumes (≥250ml)and/or repeated vomiting)
- Clinical indication of jejunal feeding
Who cannot join
- Patients not fulfilling clinical indication of jejunal feeding or contraindications for jejunal feeding
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Vienna, Department of Medicine III, ICU
Vienna, 1090
About this study
Official title: Evaluation of Two Methods of Jejunal Placement of Enteral Feeding Tubes in Critically Ill Patients: Endoscopic Versus Electromagnetic Method (CORTRAK™)
The purpose of this study is the evaluation of the success rate of jejunal tube placement comparing the endoscopic versus the electromagnetic method in a comparative ICU patient population. The investigators hypothesized that success rate of the electromagnetic jejunal tube placement will be lower than the success rate of the endoscopic method.
Read the detailed description
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 ACCP 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 patients, who are at high risk for intolerance of EN (on inotropes, sedatives, paralytic agents). When gastric enteral nutrition is insufficient despite acceptance of high gastric residual volumes and use of prokinetic agents, small bowel feeding is the best method to nevertheless 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 still 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 and their placement in the small bowel were tested and showed success rates up to 75% only. One of these alternatives is a jejunal feeding tube, which is placed using an electromagnetic sensing technique to visualize the placement process on a bedside monitor (CORTRAK™). The aim of this study is the evaluation of the success rate of jejunal tube placement comparing the endoscopic versus the electromagnetic method in a comparative ICU patient population.
- Conditions
- Critical Illness, Tube Feeding
- Being tested
- Electromagnetic imaging for jejunal tube placement (CORTRAK), Endoscopy
- Keywords
- critical illness, enteral nutrition, gastrointestinal intubation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic imaging for jejunal tube placement (CORTRAK)Device
Also called CORTRAK
Jejunal feeding tubes are placed using electromagnetic imaging (CORTRAK)
EndoscopyDevice
Also called Endoscopy (Olympus), FREKA Trelumina
Endoscopic placement of jejunal feeding tubes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | In case of meeting clinical criteria for jejunal feeding, tubes are placed using CORTRAK (electromagnetic imaging). Receives: Device: Electromagnetic imaging for jejunal tube placement (CORTRAK) |
| 2 | Active comparator | Endoscopic placement of jejunal feeding tubes fulfilling clinical indication for jejunal feeding. Receives: Device: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of jejunal placement
Measured: 24h
Secondary outcomes (1)
Time from initiation of tube placement till correct jejunal placement, time of tube in correct jejunal position, complications of placement
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 posted13 Jul 2007 (estimated)
- Study startMay 2007
- Primary completionJan 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- 66 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
- NCT00500851
- Sponsor's protocol ID
- 138/2007
- Status last verified
- Feb 2009
- First submitted
- 12 Jul 2007
- Last updated
- 30 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Holzinger U, Brunner R, Miehsler W, Herkner H, Kitzberger R, Fuhrmann V, Metnitz PG, Kamolz LP, Madl C. Jejunal tube placement in critically ill patients: A prospective, randomized trial comparing the endoscopic technique with the electromagnetically visualized method. Crit Care Med. 2011 Jan;39(1):73-7. doi: 10.1097/CCM.0b013e3181fb7b5f.
PubMed 21037470
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. 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 Electromagnetic Method (CORTRAK™)
- ClinicalTrials.gov ID
- NCT00500851
- Acronym / sponsor ID
- 138/2007
- Conditions
- Critical Illness, Tube Feeding
- Keywords
- critical illness, enteral nutrition, gastrointestinal intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 13 Jul 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 purpose of this study is the evaluation of the success rate of jejunal tube placement comparing the endoscopic versus the electromagnetic method in a comparative ICU patient population. The investigators hypothesized that success rate of the electromagnetic jejunal tube placement will be lower than the success rate of the endoscopic method.
Detailed description
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 ACCP 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 patients, who are at high risk for intolerance of EN (on inotropes, sedatives, paralytic agents). When gastric enteral nutrition is insufficient despite acceptance of high gastric residual volumes and use of prokinetic agents, small bowel feeding is the best method to nevertheless 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 still 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 and their placement in the small bowel were tested and showed success rates up to 75% only. One of these alternatives is a jejunal feeding tube, which is placed using an electromagnetic sensing technique to visualize the placement process on a bedside monitor (CORTRAK™). The aim of this study is the evaluation of the success rate of jejunal tube placement comparing the endoscopic versus the electromagnetic method in a comparative ICU patient population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Electromagnetic imaging for jejunal tube placement (CORTRAK)In case of meeting clinical criteria for jejunal feeding, tubes are placed using CORTRAK (electromagnetic imaging). |
| 2 | Active comparator | Device: EndoscopyEndoscopic placement of jejunal feeding tubes fulfilling clinical indication for jejunal feeding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Intolerance of intragastric feeding (high gastric residual volumes (≥250ml)and/or repeated vomiting)
- Clinical indication of jejunal feeding
Key exclusion criteria (1 listed)
- Patients not fulfilling clinical indication of jejunal feeding or contraindications for jejunal feeding
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 |
|---|---|---|
| Electromagnetic imaging for jejunal tube placement (CORTRAK)Also: CORTRAKJejunal feeding tubes are placed using electromagnetic imaging (CORTRAK) | Device | 1 |
| EndoscopyAlso: Endoscopy (Olympus), FREKA TreluminaEndoscopic placement of jejunal feeding tubes | Device | 2 |
Primary outcome
Success rate of jejunal placement
Time frame: 24h
1 secondary outcome
Time from initiation of tube placement till correct jejunal placement, time of tube in correct jejunal position, complications of placement
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 30 Nov 2010.
- Derived from this study: PubMed 21037470Holzinger U, Brunner R, Miehsler W, Herkner H, Kitzberger R, Fuhrmann V, Metnitz PG, Kamolz LP, Madl C. Jejunal tube placement in critically ill patients: A prospective, randomized trial comparing the endoscopic technique with the electromagnetically visualized method. Crit Care Med. 2011 Jan;39(1):73-7. doi: 10.1097/CCM.0b013e3181fb7b5f.
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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 Electromagnetic imaging for jejunal tube placement (CORTRAK) and Endoscopy in people with Critical Illness and Tube Feeding, 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 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 30 Nov 2010. 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 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?
On the ClinicalTrials.gov record for NCT00500851, which also lists 1 linked publication.
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 30 Nov 2010.