Failure to ThriveNTSNBNCT03202576
Nasogastric Tube Securement Comparison Study
A study testing Nasal Bridle in people with Failure to Thrive and Nutritional Deficiency, run by University of Colorado, Denver.
Trial summary
This study evaluates the use of tape to secure nasogastric tubes compared to securement with a nasal bridle device. Read more about this study
- Who is it for?
- Ages 1 day to 21 years
- Conditions the study is for
- Failure to Thrive, Nutritional Deficiency, Constipation
- What is being tested?
- Nasal Bridle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 20 Aug 2020
- 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 1 day to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Admitted to Children's Hospital Colorado to:
- 6th floor surgical inpatient unit, or
- 8th floor medical inpatient unit, or
- Heart Institute (Cardiac Intensive Care Unit or Cardiac Progressive Care Unit), or
- Interventional Radiology.
- Require a nasogastric or transpyloric tube (Corpak tube or clear feeding tube) for feeding or bowel cleanout.
Show all 9Show fewer
- Predicted length of use is at least 48 hours.
- Newborn up to 21 years of age
- Have a completed consent for enrollment into the study.
Who cannot join
- Burn patients because standard for placement is the nasal bridle;
- Patients with contraindications for bridle placement , such as
- mechanical obstruction of the nasal airway
- facial or nasal fractures
- fracture of the anterior part of the cranium, or basilar skull fractures
- Any tubes placed for decompression (i.e. Salem Sump tubes)
- Nasally intubated, or
- With CPAP/BiPAP.
About this study
Official title: Nasogastric Tube Securement: Comparison of Standard Practice Versus Nasal Bridle for Pediatric Hospitalized Patients
This study evaluates the use of tape to secure nasogastric tubes compared to securement with a nasal bridle device.
Read the detailed description
Patients who need to have a tube placed through their nose and into their stomach for medical treatments will sometimes have it accidentally removed. A nasal bridle is a device where a magnetic is used to attach a small piece of cloth tape that loops around the nasal septum bone and secures to the nasal gastric tube to prevent it from being pulled out accidentally.
- Conditions
- Failure to Thrive, Nutritional Deficiency, Constipation, Bowel Obstruction, Feeding and Eating Disorders
- Being tested
- Nasal Bridle
- Keywords
- nasogastric tube, microbridle
- Medical subject headings
- Failure to Thrive, Malnutrition, Constipation, Intestinal Obstruction, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal BridleDevice
Also called Microbridle
Nasal bridle placement and securement of the tube. Instead of taping the tube to the patient's face, nose or upper lip the bridle is a device whereby a magnetic retrieval system is attached to 1/8 inch umbilical tape which is inserted via the nares, looping around the nasal septum and vomer bone and ending with both ends of the bridle (umbilical tape) secured together and to the feeding tube just outside the nose.
| Study group | Role | What they receive |
|---|---|---|
| Nasogastric tube standard securement | No intervention | Standard securement of nasogastric tube with adhesive tape |
| Nasogastric Tube Nasal Bridle Securement | Experimental | Securement of NG with AMT Micro Bridle Receives: Device: Nasal Bridle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tube dislodgment
Compare the rate/percent of nasogastric tube dislodgement utilizing standard tube securement practice vs. nasal bridle (micro bridle) tube securement device in pediatric hospitalized patients.
Measured: Up to 4 weeks
Secondary outcomes (6)
Device usability
Ease of use of the nasal bridle device
Measured: Up to 4 weeks
Radiation exposure
Number of X-rays to confirm tube placement.
Measured: Up to 4 weeks
Cost
Average costs among groups related to naso-gastric (NG) tube placement and replacement
Measured: Up to 4 weeks
Restraint use
Use of restraints for the purpose of tube protection.
Measured: Up to 4 weeks
Skin integrity
Skin integrity: complications/issues
Measured: Up to 4 weeks
Patient/Caregiver Satisfaction
Patient/caregiver satisfaction with bridle.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Oct 2016
- Primary completion31 Mar 2020
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Failure to ThriveStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Evaluate the securement of the Nasogastric tube either by standard securement or using a Nasal Bridal securement method.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashley Banks (Taubert-Dupey), BSN, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202576
- Sponsor's protocol ID
- 16-0691
- Acronym
- NTSNB
- Status last verified
- Dec 2020
- First submitted
- 12 Jun 2017
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bechtold ML, Nguyen DL, Palmer LB, Kiraly LN, Martindale RG, McClave SA. Nasal bridles for securing nasoenteric tubes: a meta-analysis. Nutr Clin Pract. 2014 Oct;29(5):667-71. doi: 10.1177/0884533614536737.
PubMed 25606648Brugnolli A, Ambrosi E, Canzan F, Saiani L; Naso-gastric Tube Group. Securing of naso-gastric tubes in adult patients: a review. Int J Nurs Stud. 2014 Jun;51(6):943-50. doi: 10.1016/j.ijnurstu.2013.12.002. Epub 2013 Dec 25.
PubMed 24440003Gunn SR, Early BJ, Zenati MS, Ochoa JB. Use of a nasal bridle prevents accidental nasoenteral feeding tube removal. JPEN J Parenter Enteral Nutr. 2009 Jan-Feb;33(1):50-4. doi: 10.1177/0148607108321704. Epub 2008 Sep 30.
PubMed 18827069Parks J, Klaus S, Staggs V, Pena M. Outcomes of nasal bridling to secure enteral tubes in burn patients. Am J Crit Care. 2013 Mar;22(2):136-42. doi: 10.4037/ajcc2013105.
PubMed 23455863
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasogastric Tube Securement: Comparison of Standard Practice Versus Nasal Bridle for Pediatric Hospitalized Patients
- ClinicalTrials.gov ID
- NCT03202576
- Acronym / sponsor ID
- NTSNB / 16-0691
- Conditions
- Failure to Thrive, Nutritional Deficiency, Constipation, Bowel Obstruction, Feeding and Eating Disorders
- Keywords
- nasogastric tube, microbridle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 28 Jun 2017 (actual)
- 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.
This study evaluates the use of tape to secure nasogastric tubes compared to securement with a nasal bridle device.
Detailed description
Patients who need to have a tube placed through their nose and into their stomach for medical treatments will sometimes have it accidentally removed. A nasal bridle is a device where a magnetic is used to attach a small piece of cloth tape that loops around the nasal septum bone and secures to the nasal gastric tube to prevent it from being pulled out accidentally.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Evaluate the securement of the Nasogastric tube either by standard securement or using a Nasal Bridal securement method.
| Arm | Type | Receives |
|---|---|---|
| Nasogastric tube standard securement | No intervention | –Standard securement of nasogastric tube with adhesive tape |
| Nasogastric Tube Nasal Bridle Securement | Experimental | Device: Nasal BridleSecurement of NG with AMT Micro Bridle |
Who may qualify
- Ages
- 1 day to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Admitted to Children's Hospital Colorado to:
- Require a nasogastric or transpyloric tube (Corpak tube or clear feeding tube) for feeding or bowel cleanout.
- Predicted length of use is at least 48 hours.
- Newborn up to 21 years of age
- Have a completed consent for enrollment into the study.
Key exclusion criteria (8 listed)
- Burn patients because standard for placement is the nasal bridle;
- Patients with contraindications for bridle placement , such as
- Any tubes placed for decompression (i.e. Salem Sump tubes)
- Nasally intubated, or
- With CPAP/BiPAP.
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 |
|---|---|---|
| Nasal BridleAlso: MicrobridleNasal bridle placement and securement of the tube. Instead of taping the tube to the patient's face, nose or upper lip the bridle is a device whereby a magnetic retrieval system is attached to 1/8 inch umbilical tape which is inserted via the nares, looping around the nasal septum and vomer bone and ending with both ends of the bridle (umbilical tape) secured together and to the feeding tube just outside the nose. | Device | Nasogastric Tube Nasal Bridle Securement |
Primary outcome
Tube dislodgment
Time frame: Up to 4 weeks
Compare the rate/percent of nasogastric tube dislodgement utilizing standard tube securement practice vs. nasal bridle (micro bridle) tube securement device in pediatric hospitalized patients.
6 secondary outcomes
Device usability
Time frame: Up to 4 weeks
Radiation exposure
Time frame: Up to 4 weeks
Cost
Time frame: Up to 4 weeks
Restraint use
Time frame: Up to 4 weeks
Skin integrity
Time frame: Up to 4 weeks
Patient/Caregiver Satisfaction
Time frame: Up to 4 weeks
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 17 Dec 2020.
- Results publication: PubMed 25606648Bechtold ML, Nguyen DL, Palmer LB, Kiraly LN, Martindale RG, McClave SA. Nasal bridles for securing nasoenteric tubes: a meta-analysis. Nutr Clin Pract. 2014 Oct;29(5):667-71. doi: 10.1177/0884533614536737.
- Results publication: PubMed 24440003Brugnolli A, Ambrosi E, Canzan F, Saiani L; Naso-gastric Tube Group. Securing of naso-gastric tubes in adult patients: a review. Int J Nurs Stud. 2014 Jun;51(6):943-50. doi: 10.1016/j.ijnurstu.2013.12.002. Epub 2013 Dec 25.
- Results publication: PubMed 18827069Gunn SR, Early BJ, Zenati MS, Ochoa JB. Use of a nasal bridle prevents accidental nasoenteral feeding tube removal. JPEN J Parenter Enteral Nutr. 2009 Jan-Feb;33(1):50-4. doi: 10.1177/0148607108321704. Epub 2008 Sep 30.
- Results publication: PubMed 23455863Parks J, Klaus S, Staggs V, Pena M. Outcomes of nasal bridling to secure enteral tubes in burn patients. Am J Crit Care. 2013 Mar;22(2):136-42. doi: 10.4037/ajcc2013105.
- Individual participant dataSharing planned: No
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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.
Ashley Banks (Taubert-Dupey), BSN principal investigator
Children's Hospital Colorado
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Bridle in people with Failure to Thrive and Nutritional Deficiency, run by University of Colorado, Denver.
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 9 inclusion and 8 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Tube dislodgment (time frame: Up to 4 weeks). 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 NCT03202576, which also lists 4 linked publications.
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 17 Dec 2020.