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
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Incidence and characteristics of all types of adverse events
研究概览
简要总结
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.
详细描述
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:
- 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.
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 NCS
- •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.
排除标准
- •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
结局指标
主要结局
Incidence and characteristics of all types of adverse events
时间窗: 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.
次要结局
- Rate of inadvertent dislodgement of a small bore feeding tube while in the ICU(During the ICU admission (up to 4 weeks))
- Proportion of total daily caloric goal delivered.(Measured daily for the duration of the ICU admission (up to 4 weeks))
研究者
Vininder K. Bains
Principal Investigator
University of British Columbia