A Pilot Study in Healthy Volunteers of McKay Airway - An Improved Oral Airway for Awake Fibre-optic Intubation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Time to visualize cords.
研究概览
简要总结
When endotracheal intubation is known or predicted to be difficult, patients are intubated awake using a flexible bronchoscope (awake fibre-optic intubation: AFI) so that they can protect their airway with normal upper airway muscle activity until the endotracheal tube (ETT) is safely in place. New bite blocks have been invented for bag mask ventilation but are not suitable for AFI.1 A newly invented airway device, the McKay airway, may provide a better solution for AFI by enabling jaw thrust, a condition where the upper airway is opened more as the jaw is protruded forward. It may also be more comfortable for awake users. A study is proposed to assess the functionality of the device for this purpose.
To protect the bronchoscope, a bite block is used during AFI to protect the very delicate glass fibres from damage from inadvertent biting by the patient. Currently used bite blocks protect the scope, but do not position the jaw optimally for scoping. The proposed device is an attempt to improve upon current bite blocks by both protecting the bronchoscope and positioning the jaw optimally.
Hypothesis: Residents in training in the Division of Respirology have limited experience in fibre-optic bronchoscopy and perform it under the direct supervision of an expert. Null hypothesis: the time to visualization of vocal cords with a fibre-optic bronchoscope by residents learning in the Division of Respirology will be no different with the McKay airway than with the conventional bite block or Williams Airway.
详细描述
INTRODUCTION When endotracheal intubation is known or predicted to be difficult, patients are intubated awake using a flexible bronchoscope so that they can protect their airway with normal upper airway muscle activity until the endotracheal tube (ETT) is safely in place. A newly invented airway device, the McKay airway, (Appendix 2) may provide a better solution to placing an ETT into the windpipe of an awake patient, (awake fibre-optic intubation: AFI) A study is proposed to assess the functionality of the device for this purpose.
To protect the bronchoscope, a bite block is used during AFI to protect the very delicate glass fibres from damage from inadvertent biting by the patient. Currently used bite blocks (Appendix 2, figure 5) protect the scope, but do not position the jaw or bronchoscope optimally for scoping. This is not a problem for experienced bronchoscopists such as respirologists, but can be for those, like anesthesiologists, who do bronchoscopy infrequently. For these, the proposed device may be an improvement upon current bite blocks.
Hypothesis: Residents in training in the Division of Respirology have limited experience in fibre-optic bronchoscopy and perform it under the direct supervision of an expert. Null hypothesis: the time to visualization of vocal cords with a fibre-optic bronchoscope by residents learning in the Division of Respirology will be no different with the McKay airway than with the conventional bite block.
Experimental design: The proposed experiment is an unblinded repeated measures interventional clinical trial with concealed randomization of which device is used first and which second. Randomization will be by a computer-generated random number table (1s and 2s where 1 is conventional bite block is used first and 2 means McKay airway first) transcribed to paper cards in numbered opaque envelopes to be opened just prior to bronchoscopy.
Primary outcome: Time from beginning insertion of bronchoscope into the bite block to visualization of vocal cords.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants are of two kinds, first, anesthesiologists and anesthesia residents who will perform partial bronchoscopy, and
- •secondly, healthy volunteers. Healthy volunteers will be recruited from hospital staff, residents and students at Royal University Hospital.
排除标准
- •Excepted anesthesiologists and residents will be those who do not wish to participate in the study.
- •Excepted volunteers will be those who do not wish to participate in the study and those with a lidocaine allergy.
研究组 & 干预措施
ConMed bite block
Standard bite block (Conmed Bite Block; Conmed Corp., Utica NY, USA)
干预措施: McKay airway (Device)
ConMed bite block
Standard bite block (Conmed Bite Block; Conmed Corp., Utica NY, USA)
干预措施: Williams Airway (Device)
Williams Airway
Williams Airway Intubator (Williams Airway Intubator Ltd, Calgary, Canada)
干预措施: ConMed bite block (Device)
Williams Airway
Williams Airway Intubator (Williams Airway Intubator Ltd, Calgary, Canada)
干预措施: McKay airway (Device)
McKay airway
A new device that enables maintenance of jaw thrust. (US patent application 16/098,530)
干预措施: ConMed bite block (Device)
McKay airway
A new device that enables maintenance of jaw thrust. (US patent application 16/098,530)
干预措施: Williams Airway (Device)
结局指标
主要结局
Time to visualize cords.
时间窗: 5 minutes
Time in seconds from starting bronchoscope insertion to cord visualization.
Ease of use.
时间窗: 5 minutes
Ordinal scale comparison with standard bite block for ease of obtaining a bronchoscopic view of vocal cords or epiglottis (scale of 1 to 5 - see data sheets below).
次要结局
- Usefulness.(5 minutes)
研究者
William McKay
M.D.
University of Saskatchewan