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

April 30, 2018 updated by: Vininder K. Bains, University of British Columbia

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 altered level of consciousness, delirium, and/or dependence on mechanical ventilation. Feeding tubes are traditionally secured with adhesive tape, making dislodgement of the tube possible. Dislodgement of feeding tubes can lead to suboptimal caloric intake and increased risk of aspiration of feeds/pneumonia. An alternative to this is the nasal bridle securement device (NBSD), which has been shown to have lower rates of tube dislodgement, but the evidence is limited as it is a relatively new medical device. There is also little documented about any adverse events associated with use of the NBSD.

Prior to 2016, all small bore feeding tubes inserted in ICU patients at St. Paul's Hospital were secured with adhesive tape exclusively. The ICU team began using NBSD in 2016 only in patients who were at higher risk for, or with, tube dislodgement. The clinical indications outlined in our Nursing Practice Standards (i.e., "Nursing Practice Standard NCS5652 - Nasal Bridle") are: 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.

PURPOSE: The purpose of this study is three-fold, in patients who demonstrated a higher risk for, or with, tube dislodgement: to describe the incidence and characteristics of adverse events associated with NBSD; to examine the effectiveness of the NBSD at prevention of inadvertent dislodgement; to assess if use of this devise is associated with a difference in the proportion of total caloric goal delivered.

RESEARCH QUESTIONS:

  1. To determine the incidence and characteristics of all types of adverse events associated with the use of NBSD to secure small bore feeding tubes in ICU patients who have demonstrated a high risk for, or with, tube dislodgement.

  2. To determine if there is a difference in the rate of inadvertent dislodgement of small bore feeding tubes in ICU patients who demonstrate a high risk for, or with, tube dislodgement between ICU patients whose feeding tube is secured with a NBSD versus those who were secured with tape. Rate of tube dislodgement is defined as number of tube dislodgements per total number ICU days with a small bore feeding tube in place.

    Null hypothesis: there is no difference in the rate of inadvertent tube dislodgement.

    Alternate hypothesis: there is a difference in the rate of inadvertent tube dislodgement.

  3. To determine if there is a difference in the proportion of total caloric goals delivered in ICU patients with small bore feeding tubes with a high risk for or with tube dislodgement in ICU patients whose feeding tube is secured with a NBSD versus those who were secured with tape.

Null hypothesis: there is no difference in the proportion of total caloric goals delivered.

Alternate hypothesis: there is a difference in the proportion of total caloric goals delivered.

RESEARCH DESIGN: The prospective observational treated group will include all ICU patients who required a NBSD securement for their feeding tube as per standard practice (i.e., PHC Nursing Practice Standard NCS5652 - Nasal Bridle) from when ethics and operational approvals are obtained until December 31, 2018.

A historical comparison group will be selected from patients admitted to ICU between September 1, 2014 and September 30, 2015 (prior to use of NBSD in the ICU) who have a small bore feeding tube and match key variables.

Since the NBSD is used only in a selected number of ICU patients, in order to select an equivalent sample for the historical comparison group, the investigators will use the ICU database to identify key variables for matching. The patients who were admitted to the ICU from October 1, 2016 until October 30, 2017 and had a small bore feeding tube will be the Interim Group. Using the ICU Database, a statistical comparison of variables in patients from the Interim Group who had, versus did not have, a NBSD to secure their small bore feeding tube will be used to identify what key variables should be used for selecting the historical comparison group.

INCLUSION/EXCLUSION 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.

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 - Nasal Bridles"

MEASUREMENT: Demographic data (i.e., age, gender, comorbidities etc.), diagnosis and admission history (i.e., admission date, diagnoses, length of stay, feeding tube placement etc.) will be used to describe and compare the historical comparison group and the prospective observational treated group. To address the first research question regarding adverse events, all types of adverse events associated with the use of the NBSD will be recorded, including adverse events associated with its insertion, use, and removal. To address the second research question regarding inadvertent dislodgement, both the number of inadvertent dislodgements, and duration of tube retainment will be compared between the treated and historical comparison group. To address the third research question regarding caloric intake, the proportion of daily total caloric goal delivered will be compared between the treated and historical comparison group.

DATA COLLECTION: There are three sources of data for this study. The ICU Database has data from every admitted ICU patient. It includes demographic data, diagnoses, admission history, information on a number of procedures and interventions like the use of small bore feeding tubes, patient assessments, and patient outcomes. The ICU Nasal Bridle Database collects information for every ICU patient which has a NBSD inserted (see "Nasal Bridle Tracker Form" attached in Section 9.8.B.). It records data on insertion details, removal details and additional information on adverse event or other issues. The patient chart will be reviewed to collect additional information about the caloric goals and actual total caloric intake. See the NBA-ICU Data Collection Form (Section 9.8.A.) for further details.

STATISTICAL ANALYSIS: Descriptive statistics will be used to compare demographic variables between the prospective observational treated group and the historical comparison group. All types of adverse events including unintentional tube dislodgement, events associated with insertion, use or removal of the NBSD and all other will be qualitatively and quantitatively described. The Goodness of Fit Test or the non-parametric equivalent (Fisher's Exact Test) will be used to assess if there is a difference in the rate of inadvertent dislodgement. The Student T Test will be used to assess if there is a difference in proportion of total caloric goal delivered between treated and historical comparison group.

Study Type

Observational

Enrollment (Anticipated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Recruiting
        • Providence Health Care
        • Contact:
        • Sub-Investigator:
          • Simran Dukhia
        • Sub-Investigator:
          • Melanie Steele
        • Sub-Investigator:
          • Roger Esau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

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 Names:
  • AMTBridle TM: Nasal Tube Retaining System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the ICU admission (up to 4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
During the ICU admission (up to 4 weeks)
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)
Measured daily for the duration of the ICU admission (up to 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Providence Healthcare

Investigators

  • Principal Investigator: Laurel Aeberhardt, RD, Providence Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2018

Primary Completion (Anticipated)

February 24, 2019

Study Completion (Anticipated)

February 24, 2019

Study Registration Dates

First Submitted

December 18, 2017

First Submitted That Met QC Criteria

December 28, 2017

First Posted (Actual)

January 2, 2018

Study Record Updates

Last Update Posted (Actual)

May 2, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H16-03176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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