An interventional study of Endotracheal intubation in Spinal Diseases, Other Biomechanical Lesions of Cervical Region and Tracheal Intubation Morbidity, sponsored by University of Iowa. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-08-07.
Sponsored by University of Iowa · Not applicable, Interventional, and Basic science
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.
267 studies on the registry are indexed under Spinal Diseases; 54 are open to participants now.
This study's enrollment of 14 is below the median of 52 across 166 interventional studies indexed under Spinal Diseases.
Browse Spinal Diseases studies →University of Iowa is the lead sponsor of 276 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
The Airtraq is an alternative indirect laryngoscope that appears to cause less cervical spine motion during intubation that conventional direct laryngoscopy (Macintosh blade)
Procedure: Endotracheal intubation
This arm constitutes intubation with a conventional direct laryngoscopy with a Macintosh blade which has been shown to result in cervical spine extension, particularly in the upper cervical segments.
Procedure: Endotracheal intubation
Study patients undergo endotracheal intubation using both a conventional direct laryngoscope (Macintosh) and an alternative indirect laryngoscope (Airtraq). The order of intubation (Macintosh then Airtraq--or--Airtraq then Macintosh) is randomized.
Cervical spine segmental intervertebral motion
Lateral fluoroscopy is used to measure cervical spine motion during endotracheal intubation.
Time frame: Data collection takes place during two sequential endotracheal intubations (40-45 seconds), with follow-up assessments on postoperative days 1, 3, and 7.
Laryngoscope blade force distribution
"Pressure-mat" technology is used to measure spacially distributed forces applied by the laryngoscope blade during endotracheal intubation.
Time frame: 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
An image of the glottis during intubation is obtained for off-line measurement of the percentage of glottic opening as seen by the laryngoscopist.
Time frame: Data collection takes place during two sequential endotracheal intubations (40-45 seconds), with follow-up assessments on postoperative days 1, 3, and 7.
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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