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| ID | Type | Description | Link |
|---|---|---|---|
| R01EB012048 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
| Colorado State University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Airtraq laryngoscope | Experimental | The Airtraq is an alternative indirect laryngoscope that appears to cause less cervical spine motion during intubation that conventional direct laryngoscopy (Macintosh blade) |
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| Macintosh laryngoscope | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endotracheal intubation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cervical spine segmental intervertebral motion | Lateral fluoroscopy is used to measure cervical spine motion during endotracheal intubation. | Data collection takes place during two sequential endotracheal intubations (40-45 seconds), with follow-up assessments on postoperative days 1, 3, and 7. |
| Measure | Description | Time Frame |
|---|---|---|
| Laryngoscope blade force distribution | "Pressure-mat" technology is used to measure spacially distributed forces applied by the laryngoscope blade during endotracheal intubation. | Data collection takes place during two sequential endotracheal intubations (40-45 seconds), with follow-up assessments on postoperative days 1, 3, and 7. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley J Hindman, M.D. | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18043056 | Background | LeGrand SA, Hindman BJ, Dexter F, Weeks JB, Todd MM. Craniocervical motion during direct laryngoscopy and orotracheal intubation with the Macintosh and Miller blades: an in vivo cinefluoroscopic study. Anesthesiology. 2007 Dec;107(6):884-91. doi: 10.1097/01.anes.0000291461.62404.46. | |
| 19104166 | Background | Santoni BG, Hindman BJ, Puttlitz CM, Weeks JB, Johnson N, Maktabi MA, Todd MM. Manual in-line stabilization increases pressures applied by the laryngoscope blade during direct laryngoscopy and orotracheal intubation. Anesthesiology. 2009 Jan;110(1):24-31. doi: 10.1097/ALN.0b013e318190b556. |
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| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
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| 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. |
| Data collection takes place during two sequential endotracheal intubations (40-45 seconds), with follow-up assessments on postoperative days 1, 3, and 7. |
| 21326090 | Background | Hindman BJ, Palecek JP, Posner KL, Traynelis VC, Lee LA, Sawin PD, Tredway TL, Todd MM, Domino KB. Cervical spinal cord, root, and bony spine injuries: a closed claims analysis. Anesthesiology. 2011 Apr;114(4):782-95. doi: 10.1097/ALN.0b013e3182104859. |
| 18477276 | Background | Hirabayashi Y, Fujita A, Seo N, Sugimoto H. A comparison of cervical spine movement during laryngoscopy using the Airtraq or Macintosh laryngoscopes. Anaesthesia. 2008 Jun;63(6):635-40. doi: 10.1111/j.1365-2044.2008.05480.x. |
| 19512871 | Background | Turkstra TP, Pelz DM, Jones PM. Cervical spine motion: a fluoroscopic comparison of the AirTraq Laryngoscope versus the Macintosh laryngoscope. Anesthesiology. 2009 Jul;111(1):97-101. doi: 10.1097/ALN.0b013e3181a8649f. |
| 35551148 | Derived | Hindman BJ, Dexter F, Gadomski BC, Puttlitz CM. Relationship Between Glottic View and Intubation Force During Macintosh and Airtraq Laryngoscopy and Intubation. Anesth Analg. 2022 Oct 1;135(4):815-819. doi: 10.1213/ANE.0000000000006082. Epub 2022 May 13. |