跳至主要内容
临床试验/NCT00869648
NCT00869648已完成不适用

Head Positions to Open the Upper Airway- a Pilot Study

Medical University Innsbruck0 个研究点目标入组 60 人开始时间: 2009年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
主要终点
Head position angles

研究概览

简要总结

Ventilation during basic life support improves survival in cardiac arrest patients significantly. Unfortunately, this is in contrast to the willingness of potential rescuers to perform mouth-to-mouth ventilation. For example, although healthcare professionals would perform mouth-to-mouth ventilation on a 4-year old drowned child in >90% of cases, this likelihood would decrease to ~10% in the case of a young male unconscious patient in a San Francisco public bus. Possibly, lay rescuers would perform assisted ventilation more often if a simple ventilation device were available. However, both the willingness to perform assisted ventilation plus the ability to open and to maintain the airway patent are necessary to ensure efficient ventilation in an unconscious patient with an unprotected upper airway.

Since retention of skills after basic life support classes are notoriously low, a resuscitation tool should incorporate self-explanatory features to improve applicability, and to provide built-in safety. Thus, an option could be to ensure an open airway by the use of a built-in indicator within a ventilating device to confirm correct head extension. One possible approach may be to determine head position angles that make an open airway likely, and integrate these angles into a scale on a ventilating device; however, safe head extension needs to be determined first to prevent harm.

The purpose of this study is to determine head position angles and ventilation parameters reflecting neutral position, maximal extension and a position deemed optimal by an anaesthesiologist in patients undergoing anaesthesia induction for elective surgery in a first step to design a ventilating device to optimise ventilation of an unprotected upper airway. The investigators will ventilate 30 patients with a pillow under the head simulating ventilation in the operating theater, and 30 patients without a pillow under the head simulating ventilation during cardiopulmonary resuscitation.

Dentures will not be removed during assessment. After anaesthesia induction the head will be consecutively flexed in the three positions and measurements performed. Afterwards, general anaesthesia and surgery will ensue. The health risk for this extra minutes of mask ventilation is minimal.

The null hypothesis is that there will be no differences in head position angles and ventilation parameters.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I and II

排除标准

  • Cervical spine pathologies
  • Peripheral nerve deficiencies
  • Body mass index >40kg/m2
  • Obvious primary or secondary craniofacial abnormalities

结局指标

主要结局

Head position angles

时间窗: Within 5 minutes after anaesthesia induction

次要结局

  • Tidal volume(Within 5 minutes after anaesthesia induction)

研究者

发起方
Medical University Innsbruck
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Paal, PD MD MBA EDAIC EDIC

PD MD MBA EDAIC EDIC

Medical University Innsbruck

相似试验