Pilot Study to Assess the Efficacy and Safety of the Lubo Cervical Collar
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
The Lubo cervical collar is a device that simultaneously maintains cervical spine control and keeps an open airway in a non-invasive manner. The purpose of the device is to manage cervical spine control and airway protection in the trauma patient.
详细描述
Cervical spine stabilization is usually achieved by a semi-rigid collar. While these collars achieve the goal of supporting the cervical spine, they limit the possibilities for jaw thrust or other airway manipulations. Definitive airway protection usually must be achieved by orotracheal intubation. Thee Lubo collar is a device that simultaneously maintains cervical spine control and keeps an open airway in a non-invasive manner that is simple to operate. The objective of the study is to test the safety of the collar volunteers. The study is composed of two stages:1.healthy volunteers that will not undergo any intervention except testing the LCC.2. second group of patients scheduled to undergo an operation under general anesthesia with endotracheal intubation or laryngeal mask airway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females.
- •Normal airway anatomy, with expected easy ventilation and intubation.
- •Anesthetic risk- class 1or 2 by the American Society of Anesthesiologists (ASA) criteria.
- •Patients scheduled for an elective operation at the lower part of the body in supine position not supposed to last more then 2 hours.
- •Anesthetic plan- general anesthesia
排除标准
- •Known problems of the cervical spine.
- •Known problems of the temporomandibular joint.
- •Suspected difficult intubation or difficult mask ventilation.
- •High risk of gastric content aspiration.
- •Morbid obesity (BMI >32).
- •Psycho- social problems
- •Any cerebrovascular or cardiovascular disease
- •Known hypersensitivity reactions to fabrics or plastics
- •Any rash, eruption, wounds or sores at the upper torso, the neck and the head.
- •No participation in other clinical trail at the time of the trail