Measuring the Effect of Angulus on Patient-elevation Compliance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Angulus, LLC
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Compliance to Head of Bed Elevation to 30 Degree or More.
研究概览
简要总结
Ventilator-associated events (VAE) are a scourge of critical care settings and hospital systems at large. There is extensive evidence that ventilator-associated pneumonia (VAP) and related VAEs increase mortality rates in critically ill patients by up to 50%, while simultaneously increasing cost of care. C
Best-practice guidelines state that positioning ventilated patients at an angle between 30-45 degrees significantly reduces the potential for VAP and other VAE to develop. While the intent of the guidelines is to govern patient elevation angle, the lack of a mechanism to accurately measure patient elevation requires that nurses rely on the head-of-bed (HOB) protractor - a tool which reflects the angle of the bed, not the patient - to measure compliance. Depending upon the position and posture of the patient in the bed, a patient's elevation angle may be significantly different from the HOB angle. Critical care teams currently rely on built-in HOB protractors and digital inclinometers that measure the angle of the bed not the patient.
Angulus, LLC has developed a dual-component Angulus sensor to fill this gap in critical care technology. Angulus enables critical care practitioners to instantaneously understand a patient's elevation, identify when the patient is outside of the desired 30-45 degree recumbency scope, and efficiently correct the patient's orientation with immediate feedback. Angulus supports real-time minute-to-minute data display as well as longitudinal aggregation of data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mechanical ventilation with any modality (e.g., endotracheal tube, tracheostomy)
- •Age between 18 and 75 years
排除标准
- •Patients with a known allergy to the encasing materials
- •Patients who are advised to be positioned outside of the 30-45 degree scope.
- •Patients with any major chest wall abnormalities, or defects, including but not limited to:
- •post-cardiac surgical patients
- •pectus excavatum (or any congenital chest wall deformity)
- •complicated skin and soft tissue infections on the chest wall
- •heart-lung machine systems
研究组 & 干预措施
Feedback
The ICU with feedback will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation.
干预措施: Angulus (Device)
No Feedback
The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses.
干预措施: Angulus (Device)
结局指标
主要结局
Compliance to Head of Bed Elevation to 30 Degree or More.
时间窗: 3 months
Measured as a continuous variable between 0% and 100% compliance.
次要结局
未报告次要终点
