The Effect of Adhesive Versus Endotracheal Tube Fastener in Critically Ill Adults: The Endotracheal Tube Securement Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Rate of Any Incidence of the Following: Presence of Lip Ulcer, Endotracheal Tube Dislodgement, or Facial Skin Tears From the Time of Randomization to the Earlier of Death or 48 Hours After Extubation
研究概览
简要总结
To evaluate the safety and efficacy of endotracheal tube securement techniques, a pragmatic, randomized controlled trial will compare the effect of adhesive tape versus endotracheal tube fastener on complications including lip ulcers, facial skin tears, endotracheal tube dislodgement, and ventilator associated pneumonia among critically ill adults requiring intubation and mechanical ventilation for at least 24 hours.
详细描述
Background: The optimal securement method of endotracheal tubes is unknown, but should provide adequate security while minimizing complications. This study tests the hypothesis that use of an endotracheal tube fastener would reduce complications among critically ill adults undergoing endotracheal intubation. This hypothesis will be tested in a pragmatic, single center, randomized trial comparing the effect of adhesive tape versus endotracheal tube fastener (Hollister) among critically ill adults requiring intubation and mechanical ventilation for at least 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Patient intubated prior to admission to the MICU and the intubation time was less than 12 hours from the time of admission
- •Patients intubated in the MICU for greater than 24 hours
排除标准
- •intubated greater than 12 hours prior to admission to the MICU
- •presence of oral mucosa or facial skin breakdown prior to enrollment
- •required nasotracheal intubation,
- •had a documented allergy to tape
- •prisoners
研究组 & 干预措施
Adhesive Tape
Patients in adhesive tape arm had endotracheal tube secured with adhesive tape
干预措施: Adhesive Tape (Device)
Tube Fastener
Patients in the tube fastener arm had endotrachel tube secured with tube fastener
干预措施: Tube Fastener (Device)
结局指标
主要结局
Rate of Any Incidence of the Following: Presence of Lip Ulcer, Endotracheal Tube Dislodgement, or Facial Skin Tears From the Time of Randomization to the Earlier of Death or 48 Hours After Extubation
时间窗: 48 hours post extubation up to 3 months
Rate per 1000 ventilator days of any incidence of the following: presence of lip ulcer, endotracheal tube dislodgement, or facial skin tears from the time of randomization to the earlier of death or 48 hours after extubation
次要结局
- Number of Participants With Lip Ulcers(48 hours post extubation up to 3 months)
- Number of Participants With Facial Skin Tear(48 hours post extubation up to 3 months)
- Number of Participants With Ett Dislodgement(duration of intubation up to 3 months)
研究者
Todd Rice
Associate Professor of Medicine
Vanderbilt University Medical Center