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Cervical Spine Biomechanics During Endotracheal Intubation

N/A
Waitlist Available
Led By Bradley J Hindman, M.D.
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up data collection takes place during two sequential endotracheal intubations (40-45 seconds), with follow-up assessments on postoperative days 1, 3, and 7.
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Tracheal Intubation Morbidity
  • Spinal Diseases
  • Cervical Biomechanical Lesions
  • Spinal Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~data collection takes place during two sequential endotracheal intubations (40-45 seconds), with follow-up assessments on postoperative days 1, 3, and 7.
This trial's timeline: 3 weeks for screening, Varies for treatment, and data collection takes place during two sequential endotracheal intubations (40-45 seconds), with follow-up assessments on postoperative days 1, 3, and 7. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cervical spine segmental intervertebral motion
Secondary study objectives
Glottic visualization
Laryngoscope blade force distribution

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Airtraq laryngoscopeExperimental Treatment1 Intervention
The Airtraq is an alternative indirect laryngoscope that appears to cause less cervical spine motion during intubation that conventional direct laryngoscopy (Macintosh blade)
Group II: Macintosh laryngoscopeActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Endotracheal intubation
2010
Completed Phase 3
~9690

Find a Location

Who is running the clinical trial?

National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH
95 Previous Clinical Trials
21,289 Total Patients Enrolled
University of IowaLead Sponsor
471 Previous Clinical Trials
894,647 Total Patients Enrolled
Colorado State UniversityOTHER
133 Previous Clinical Trials
38,454 Total Patients Enrolled
Bradley J Hindman, M.D.Principal InvestigatorUniversity of Iowa
~1 spots leftby Jan 2026