Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT03387358

Conditions

Enteral Nutrition

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Nasal bridle securement device for small bore feeding tubes

Study Details

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.

Conditions

Enteral Nutrition

Study ID

NCT03387358

Start date

Apr 24, 2018

Status verified date

Apr, 2018

Completion date

Feb 24, 2019

Anticipated

Primary completion date

Feb 24, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Inclusion criteria for both the historical and prospective groups are: Admitted to the ICU at St. Paul's Hospital; had a small bore feeding tube in place during their ICU admission.

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.

Exclusion Criteria:

  • 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:

1. those where were not permitted to be fed by the gastrointestinal system (as per Doctor's Orders);
2. and/or did not meet the criteria for use of a NBSD as per the Nursing Practice Standard NCS5652

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Nasal bridle securement device for small bore feeding tubes

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.

Primary outcome measure

  • Incidence and characteristics of all types of adverse events [ Time Frame: During the ICU admission (up to 4 weeks) ]

Central Contacts and Locations

Locations

Providence Health Care

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

More Information

Sponsor

University of British Columbia

Last update posted

May 2, 2018

Last verified

Apr, 2018

Keywords

  • intensive care unit
  • nasal bridle securement device
  • small bore feeding tube
  • adverse events
  • enteral nutrition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2018-05-02.