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Cervical Spine Biomechanics During Endotracheal Intubation

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clinicaltrials.gov/study/NCT01369381
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT013693810
Trial Recruitment Size
140
Trial Sponsor
University of Iowa
University of Iowa
0
Trial Collaborator
Colorado State University
Colorado State University
0
Clinical Trial Start Date
2011
0
Primary Completion Date
2012
0
Study Completion Date
2012
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Basic Science0
Intervention Type
Procedure0
Interventional Trial Phase
Not Applicable0
Participating Facility
‌
University of Iowa Hospitals and Clinics
0
Official Name
Intubation Mechanics of the Stable and Unstable Cervical Spine0
Last Updated
August 7, 2012
0
Allocation Type
Randomized0
Intervention Model
Crossover Assignment0
Masking Type
Double0
Masked Party
Outcomes Assessor0
Participant0

Other attributes

Intervention Treatment
Endotracheal intubation0
Study summary

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.

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