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
|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|
|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|
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
- 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.
- 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)
- 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)
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
|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|
|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|
|Principal Investigator:||Laurel Aeberhardt, RD||Providence HealthCare|