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An Observational Study Examining Adverse Events and Effectiveness of the Nasal Bridle Securement Device in ICU Patients (NBA-ICU)

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ClinicalTrials.gov Identifier: NCT03387358
Recruitment Status : Not yet recruiting
First Posted : January 2, 2018
Last Update Posted : January 2, 2018
Sponsor:
Collaborator:
Providence HealthCare
Information provided by (Responsible Party):
Vininder K. Bains, University of British Columbia

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.

Condition or disease Intervention/treatment
Enteral Nutrition Device: Nasal bridle securement device for small bore feeding tubes

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 160 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 4 Weeks
Official Title: Nasal Bridle Assessment in the Intensive Care Unit: An Observational Study to Examine the Effectiveness and Adverse Events of the Nasal Bridle Securement Device in High Risk ICU Patients
Estimated Study Start Date : January 20, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Group/Cohort Intervention/treatment
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
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.
Other Name: AMTBridle TM: Nasal Tube Retaining System



Primary Outcome Measures :
  1. Incidence and characteristics of all types of adverse events [ Time Frame: During the ICU admission (up to 4 weeks) ]
    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.


Secondary Outcome Measures :
  1. Rate of inadvertent dislodgement of a small bore feeding tube while in the ICU [ Time Frame: During the ICU admission (up to 4 weeks) ]
    the rate of inadvertent dislodgement is defined as the number of inadvertent tube per total ICU days with a small bore feeding tube (i.e., number of dislodgment/ICU days with small bore feeding tube)

  2. Proportion of total daily caloric goal delivered. [ Time Frame: Measured daily for the duration of the ICU admission (up to 4 weeks) ]
    This is the proportion of total daily caloric goal that was actually received by the participant (i.e., 100 x actual caloric intake/goal caloric intake). Calories are measured in kilocalories (kcal)



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387358


Contacts
Contact: Laurel Aeberhardt, RD 604-682-2344 ext 62264 LAeberhardt@providencehealth.bc.ca
Contact: Vininder K Bains, MSN 604-682-2344 ext 62207 VBains@providencehealth.bc.ca

Locations
Canada, British Columbia
Providence Health Care Not yet recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Vininder K Bains, MSN    604-682-2344 ext 62207    VBains@providencehealth.bc.ca   
Sub-Investigator: Simran Dukhia         
Sub-Investigator: Melanie Steele         
Sub-Investigator: Roger Esau         
Sponsors and Collaborators
University of British Columbia
Providence HealthCare
Investigators
Principal Investigator: Laurel Aeberhardt, RD Providence HealthCare

Publications:

Responsible Party: Vininder K. Bains, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT03387358     History of Changes
Other Study ID Numbers: H16-03176
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vininder K. Bains, University of British Columbia:
intensive care unit
nasal bridle securement device
small bore feeding tube
adverse events
enteral nutrition