NCT03387358

Brief Summary

Nasal bridle securement device (NBSD) is a device used to keep feeding tubes in place. Unlike tape, it keeps tubes in place by tying the feeding tube to a fabric string that is looped in through one nostril, over the nasal bridge and out the other nostril. The purpose of this study is to measure how effective a NBSD is at keeping feeding tubes in place and what effect that will have on how many calories ICU patients receive. Also, the another objective is to measure what, if any, harmful or undesirable outcomes happen with using a NBSD in our ICU patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

April 24, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2019

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2018

Enrollment Period

10 months

First QC Date

December 18, 2017

Last Update Submit

April 30, 2018

Conditions

Enteral Nutrition

Keywords

intensive care unitnasal bridle securement devicesmall bore feeding tubeadverse eventsenteral nutrition

Outcome Measures

Primary Outcomes (1)

  • Incidence and characteristics of all types of adverse events

    Describe the prevalence and characteristics of all types of adverse events associated with use of the Nasal Bridle Securement device, including with its insertion, use and removal.

    During the ICU admission (up to 4 weeks)

Secondary Outcomes (2)

  • Rate of inadvertent dislodgement of a small bore feeding tube while in the ICU

    During the ICU admission (up to 4 weeks)

  • Proportion of total daily caloric goal delivered.

    Measured daily for the duration of the ICU admission (up to 4 weeks)

Study Arms (2)

Historical Comparison Group

This group includes patients who were admitted to St. Paul's Hospital ICU (Vancouver BC, Canada) from September 2014 to September 2015, and had a small bore feeding tube in place at some point during their ICU admission, and were matched to key variables to the prospective observational treated group.

Prospective Observational Treated Group

This group includes all patients who were admitted to St. Paul's Hospital ICU from Nov. 2017 to Dec. 2018, and nasal bridle securement device for small bore feeding tubes at some point during their ICU admission. The clinical indicators for a nasal bridle securement device outlined in our nursing practice standards include one or more of the following: recurrent nasoenteric tube dislodgement; confused and/or agitated patients; fluoroscopically or endoscopically placed nasoenteric tube; history of difficult tube placement; facial burn victims with nasoenteric tube; and/or oily skin causing decreased adhesion of traditional securement.

Device: Nasal bridle securement device for small bore feeding tubes

Interventions

Nasal bridle securement device for small bore feeding tubesDEVICE

A Nasal bridle securement device is an alternative method to securing small bore feeding tubes which are most commonly secured with adhesive tape to the nose. A nasal bridle securement device instead secures the feeding tube to a cloth ribbon that is inserted in one nostril, over then nasal bridle and out the other nostril.

Also known as: AMTBridle TM: Nasal Tube Retaining System
Prospective Observational Treated Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who were admitted to the ICU at St. Paul's Hospital in Vancouver BC between September 1 2014 and September 30, 2015 OR October 1, 2017 and December 31, 2018 and had a small bore feeding tube in place as a standard of care.

You may qualify if:

  • In addition, the prospective observational treated group will also need to have a NBSD inserted at some time during their ICU admission as per the criteria outlined in the Nursing Practice Standard NCS5652. These clinical indicators include: recurrent nasoenteric tube dislodgement, confused and/or agitated patients, fluoroscopically or endoscopically placed nasoenteric tube, history of difficult tube placement, facial burn victims with nasoenteric tube and/or oily skin causing decreased adhesion of traditional securement.
  • The historical comparison group only need to have a small bore feeding tube, secured by tape, and are matched by key variables.

You may not qualify if:

  • For both the prospective observational treated group and the historical comparison group who were admitted to the ICU and had a small bore feeding tube in place during their ICU admission, the only patients who are excluded are:
  • those where were not permitted to be fed by the gastrointestinal system (as per Doctor's Orders);
  • and/or did not meet the criteria for use of a NBSD as per the Nursing Practice Standard NCS5652

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence Health Care

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

Related Publications (11)

  • Beavan J, Conroy SP, Harwood R, Gladman JR, Leonardi-Bee J, Sach T, Bowling T, Sunman W, Gaynor C. Does looped nasogastric tube feeding improve nutritional delivery for patients with dysphagia after acute stroke? A randomised controlled trial. Age Ageing. 2010 Sep;39(5):624-30. doi: 10.1093/ageing/afq088. Epub 2010 Jul 27.

    PMID: 20667840BACKGROUND

  • 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.

    PMID: 25606648BACKGROUND

  • Brandt CP, Mittendorf EA. Endoscopic placement of nasojejunal feeding tubes in ICU patients. Surg Endosc. 1999 Dec;13(12):1211-4. doi: 10.1007/pl00009623.

    PMID: 10594268BACKGROUND

  • Brugnolli 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.

    PMID: 24440003BACKGROUND

  • Nasal Bridle Devices for the Securement of Nasoenteric Feeding Tubes in Adult Patients: Comparative Clinical Effectiveness, Safety, and Cost-Effectiveness [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2016 Dec 19. Available from http://www.ncbi.nlm.nih.gov/books/NBK424238/

    PMID: 28211665BACKGROUND

  • Jackson RS, Sharma S. Retained nasal tube bridle system insertion stylet presenting as nasal foreign body: a report of two cases. Am J Otolaryngol. 2015 Mar-Apr;36(2):296-8. doi: 10.1016/j.amjoto.2014.10.033. Epub 2014 Nov 5.

    PMID: 25465320BACKGROUND

  • Lamont T, Beaumont C, Fayaz A, Healey F, Huehns T, Law R, Lecko C, Panesar S, Surkitt-Parr M, Stroud M, Warner B. Checking placement of nasogastric feeding tubes in adults (interpretation of x ray images): summary of a safety report from the National Patient Safety Agency. BMJ. 2011 May 5;342:d2586. doi: 10.1136/bmj.d2586. No abstract available.

    PMID: 21546422BACKGROUND

  • Parks 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.

    PMID: 23455863BACKGROUND

  • Puricelli MD, Newberry CI, Gov-Ari E. Avulsed Nasoenteric Bridle System Magnet as an Intranasal Foreign Body. Nutr Clin Pract. 2016 Feb;31(1):121-4. doi: 10.1177/0884533615611858. Epub 2015 Oct 20.

    PMID: 26487513BACKGROUND

  • Seder CW, Janczyk R. The routine bridling of nasojejunal tubes is a safe and effective method of reducing dislodgement in the intensive care unit. Nutr Clin Pract. 2008 Dec-2009 Jan;23(6):651-4. doi: 10.1177/0884533608326139.

    PMID: 19033225BACKGROUND

  • Seder CW, Stockdale W, Hale L, Janczyk RJ. Nasal bridling decreases feeding tube dislodgment and may increase caloric intake in the surgical intensive care unit: a randomized, controlled trial. Crit Care Med. 2010 Mar;38(3):797-801. doi: 10.1097/CCM.0b013e3181c311f8.

    PMID: 19851098BACKGROUND

Study Officials

  • Laurel Aeberhardt, RD

    Providence Healthcare

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurel Aeberhardt, RD

CONTACT

604-682-2344LAeberhardt@providencehealth.bc.ca

Vininder K Bains, MSN

CONTACT

604-682-2344VBains@providencehealth.bc.ca

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 18, 2017

First Posted

January 2, 2018

Study Start

April 24, 2018

Primary Completion

February 24, 2019

Study Completion

February 24, 2019

Last Updated

May 2, 2018

Record last verified: 2018-04

Locations

CA(1)