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临床试验/NCT03496220
NCT03496220已完成不适用

Measuring the Effect of Angulus on Patient-elevation Compliance

Angulus, LLC2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年7月10日最近更新:
适应症
干预措施

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

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

Experimental

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

Other

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

研究者

发起方
Angulus, LLC
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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Effect of Angulus on Patient-elevation Compliance | 临床试验