Enteral Feeding IntoleranceNCT04241146
Optimal Feeding Tube Placement
A study testing Enteric Tube and CORTRAK enteral access system in people with Enteral Feeding Intolerance, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
A randomized controlled trial comparing current standard blind method to CORTRAK enteral access system (CEAS), an FDA approved electromagnetic device to place enteric tubes. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Enteral Feeding Intolerance
- What is being tested?
- Enteric Tube and CORTRAK enteral access system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2018to 21 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Inclusion Criteria: Patient admitted to pediatric floor, intermediate care unit, pediatric intensive care unit, or congenital care unit requiring post-pyloric feeding tube placement of size eight french or more and not meeting any of exclusion criteria
Exclusion Criteria: Under three kilograms, Open chest wall, Open abdominal wall
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial for Optimal Feeding Tube Placement
A randomized controlled trial comparing current standard blind method to CORTRAK enteral access system (CEAS), an FDA approved electromagnetic device to place enteric tubes.
Read the detailed description
Patient population would include patients in pediatric intensive care unit, pediatric cardiac unit, intermediate medical care unit and pediatric floor who receives postpyloric feeding tube placements. The study team are going to monitor total time and number attempts required for each successful placement, correlation of findings on x-ray versus CEAS, cost-effectiveness of this new equipment with standard blind method and decrease in radiation exposure with CEAS.
- Conditions
- Enteral Feeding Intolerance
- Being tested
- Enteric Tube, CORTRAK enteral access system
- Keywords
- enteral nutrition, radiation exposure, nursing care, pediatrics, radiation, non-ionizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteric TubeDevice
Also called Enteral nutrition tube
A post pyloric feeding tube used in patients requiring enteral nutrition
CORTRAK enteral access systemDevice
Also called CEAS
Electromagnetic guidance system for enteric feeding tube placement
| Study group | Role | What they receive |
|---|---|---|
| Standard Blind Technique of Tube placement | Active comparator | FDA approved technique of enteral nutrition tube placement Receives: Device: Enteric Tube |
| CORTRAK enteral access system (CEAS) placement | Active comparator | An electromagnetic device used to enable enteral nutrition tube placement Receives: Device: CORTRAK enteral access system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Time
Time taken for placement of enteral tube
Measured: Baseline to End of procedure up to 30 minutes
Secondary outcomes (1)
Number of X-Rays
Number of X-rays required to achieve correct tube placement
Measured: Baseline to End of procedure up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start6 Jan 2018
- Primary completion10 Oct 2018
- Study completion21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enteral Feeding IntoleranceStudies of the same condition, open and under way.
- 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- Avanos Medical
- Responsible party
- Principal investigator, Andrew D. Meyer, The University of Texas Health Science Center at San Antonio
- Investigators
- Andrew Meyer, MD, Principal investigator, University of Texas Health San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241146
- Sponsor's protocol ID
- HSC20170704H
- Status last verified
- Feb 2020
- First submitted
- 21 Jan 2020
- Last updated
- 25 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data is available to all researchers upon contact of sponsoring organization and investigator Andrew D. Meyer.
Publications
Jha P, Rupp L, Bonilla L, Gelfond J, Shah JN, Meyer AD. Electromagnetic Versus Blind Guidance of a Postpyloric Feeding Tube in Critically Ill Children. Pediatrics. 2020 Oct;146(4):e20193773. doi: 10.1542/peds.2019-3773.
PubMed 32994178
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial for Optimal Feeding Tube Placement
- ClinicalTrials.gov ID
- NCT04241146
- Acronym / sponsor ID
- HSC20170704H
- Conditions
- Enteral Feeding Intolerance
- Keywords
- enteral nutrition, radiation exposure, nursing care, pediatrics, radiation, non-ionizing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Avanos Medical
- Study start
- 6 Jan 2018 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Posted 25 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized controlled trial comparing current standard blind method to CORTRAK enteral access system (CEAS), an FDA approved electromagnetic device to place enteric tubes.
Detailed description
Patient population would include patients in pediatric intensive care unit, pediatric cardiac unit, intermediate medical care unit and pediatric floor who receives postpyloric feeding tube placements. The study team are going to monitor total time and number attempts required for each successful placement, correlation of findings on x-ray versus CEAS, cost-effectiveness of this new equipment with standard blind method and decrease in radiation exposure with CEAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Blind Technique of Tube placement | Active comparator | Device: Enteric TubeFDA approved technique of enteral nutrition tube placement |
| CORTRAK enteral access system (CEAS) placement | Active comparator | Device: CORTRAK enteral access systemAn electromagnetic device used to enable enteral nutrition tube placement |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Enteric TubeAlso: Enteral nutrition tubeA post pyloric feeding tube used in patients requiring enteral nutrition | Device | Standard Blind Technique of Tube placement |
| CORTRAK enteral access systemAlso: CEASElectromagnetic guidance system for enteric feeding tube placement | Device | CORTRAK enteral access system (CEAS) placement |
Primary outcome
Duration of Time
Time frame: Baseline to End of procedure up to 30 minutes
Time taken for placement of enteral tube
1 secondary outcome
Number of X-Rays
Time frame: Baseline to End of procedure up to 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32994178Jha P, Rupp L, Bonilla L, Gelfond J, Shah JN, Meyer AD. Electromagnetic Versus Blind Guidance of a Postpyloric Feeding Tube in Critically Ill Children. Pediatrics. 2020 Oct;146(4):e20193773. doi: 10.1542/peds.2019-3773.
- Individual participant dataSharing planned: Yes. De-identified data is available to all researchers upon contact of sponsoring organization and investigator Andrew D. Meyer.
Related trials for Enteral Feeding Intolerance
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Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
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Continuous Versus Intermittent Enteral Feeding and Gastric Residual Volume in Critically Ill Patients
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Not yet recruitingObservational study
Gut Microbiota Structure, Functional and Metabolic Profiles, and Composite Biomarkers in ICU Adults With Refractory Enteral Feeding Intolerance
Refractory Enteral Feeding Intolerance, Gut Microbiota
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Transcutaneous Auricular Stimulation Targeting Enteral Feeding Intolerance
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Not yet recruitingObservational study
JLU_Nutr_FI Registry: A Prospective Registry of Feeding Intolerance in Critically Ill Patients
Critical Illness, Feeding Intolerance
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.
Andrew Meyer, MD principal investigator
University of Texas Health San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteric Tube and CORTRAK enteral access system in people with Enteral Feeding Intolerance, run by The University of Texas Health Science Center at San Antonio 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?
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 25 Feb 2020. 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?
Yes. Results are posted in the registry (first posted 25 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Duration of Time (time frame: Baseline to End of procedure up to 30 minutes). 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 NCT04241146, 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 25 Feb 2020.