Status:
UNKNOWN
An Observational Study Examining Adverse Events and Effectiveness of the Nasal Bridle Securement Device in ICU Patients
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Providence Healthcare
Conditions:
Enteral Nutrition
Eligibility:
All Genders
18-99 years
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 n...
Detailed Description
BACKGROUND/JUSTIFICATION: Adequate nutritional support is an important part of treatment in critical illness. It is usually delivered via a nasoenteric feeding tube because ICU patients may have an al...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 24 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 24 2019
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03387358
Start Date
April 24 2018
End Date
February 24 2019
Last Update
May 2 2018
Active Locations (1)
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1
Providence Health Care
Vancouver, British Columbia, Canada, V6Z 1Y6