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临床试验/NCT01369381
NCT01369381已完成不适用

Intubation Mechanics of the Stable and Unstable Cervical Spine

University of Iowa2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Cervical spine segmental intervertebral motion

研究概览

简要总结

Current methods for endotracheal intubation in the presence of cervical spine (c-spine) instability are not evidence-based. This is so because the relationships between the forces applied during intubation (by the laryngoscope) and the resulting c-spine movement have not yet been quantitatively characterized. As a result, with the current level of knowledge, it is not known, and it is not possible to predict, which types of c-spine instability have the greatest risk of cervical spinal cord injury with intubation. This shortcoming makes it impossible to know which intubation devices and techniques are likely to be safest in the presence of c-spine instability.

To address this critical lack of knowledge, the overarching purpose of the proposed research is to: 1) quantitatively relate c-spine movement that results from the forces applied to the peri-airway tissues during intubation (force-motion relationships), and 2) use these data to develop a mathematical model of the c-spine that will predict which types of c-spine instability result in the greatest amount of abnormal c-spine motion and associated spinal cord compression during intubation.

This clinical study will utilize laryngoscope blades that are instrumented with a high resolution pressure mapping system to make high-resolution measurements of the forces and pressures of intubation while making simultaneous measurements of c-spine motion. In this study, study subjects will be intubated using both a conventional (Macintosh) laryngoscope and an alternative (Airtraq) laryngoscope. By using two different laryngoscopes, we, the investigators, will introduce forces of differing magnitudes and distributions to peri-airway tissues. The Airtraq does not require a direct line of sight to visualize the vocal cords, and among the various new alternative laryngoscopes it is the only one that has been shown to result in 30-50% less cervical motion than a conventional (Macintosh) laryngoscope. Accordingly, we hypothesize 1) 30-50% less force will be applied with the Airtraq laryngoscope than with the conventional (Macintosh) laryngoscope and 2) 30-50% less c-spine motion will occur with the Airtraq. By studying (intubating) each subject twice, any differences in the c-spine force-motion relationships between devices will be due to the devices themselves. By studying each subject twice, we can account for (and eliminate) differences among study subjects in c-spine biomechanical properties.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, 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

  • Patient Height: 5-feet, 0-inches to 6-feet, 0-inches
  • Patient body mass index: less than 30 kg/m2
  • Planned surgery requires use of C-arm fluoroscopy
  • Planned surgery to take place at University of Iowa and requires general anesthesia and orotracheal intubation

排除标准

  • The patient is a prisoner
  • The patient is pregnant
  • The patient is not competent to personally give consent
  • Neurological signs and symptoms indicating cervical spinal cord myelopathy
  • Cervical spine images demonstrating anatomic instability, traumatic injury, significant cervical stenosis, and/or spinal immobility
  • Condition associated with cervical spine anatomic abnormalities such as Rheumatoid arthritis, Down Syndrome, Ankylosing spondylitis, Osteogenesis imperfecta
  • Prior cervical spine surgery of any type
  • History of difficult endotracheal intubation
  • Currently symptomatic gastroesophageal reflux disease
  • Currently symptomatic asthma or other reactive airway disease
  • Any history of coronary artery disease
  • Any history of cerebral aneurysm(s)
  • History of vocal cord and/or glottic disease or dysfunction
  • Contraindication to receiving 100% oxygen
  • Systolic blood pressure greater than 180 mmHg
  • Diastolic blood pressure greater than 100 mmHg
  • American Society of Anesthesiologists Physical Status class of 4, 5, or 6
  • Known allergy or other adverse response to study drugs: midazolam, lidocaine, fentanyl, propofol [eggs, soy beans], rocuronium, or sevoflurane.
  • Mallampati oropharyngeal class of III or IV
  • Thyromental distance less than 6.0 cm
  • Sternomental distance less than 12.5 cm
  • Maxillary incisors loss or in poor condition

结局指标

主要结局

Cervical spine segmental intervertebral motion

时间窗: Data collection takes place during two sequential endotracheal intubations (40-45 seconds), with follow-up assessments on postoperative days 1, 3, and 7.

Lateral fluoroscopy is used to measure cervical spine motion during endotracheal intubation.

次要结局

  • Laryngoscope blade force distribution(Data collection takes place during two sequential endotracheal intubations (40-45 seconds), with follow-up assessments on postoperative days 1, 3, and 7.)
  • Glottic visualization(Data collection takes place during two sequential endotracheal intubations (40-45 seconds), with follow-up assessments on postoperative days 1, 3, and 7.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bradley J. Hindman

Professor, Department of Anesthesia

University of Iowa

研究点 (2)

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