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NCT01369381 · ClinicalTrials.gov registry record · NA
Cervical Spine Biomechanics During Endotracheal Intubation
A NA study, sponsored by University of Iowa.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT01369381: Completed NA study, sponsored by University of Iowa.
NCT01369381 is a NA study that has completed, run by University of Iowa. The registered enrollment target is 14 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01369381, a NA study, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
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
Primary Outcome
Lateral fluoroscopy is used to measure cervical spine motion during endotracheal intubation.
Interventions
- PROCEDURE Endotracheal intubation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2011-12 |
| Est. Completion | 2012-07 |
| Phase | NA |
What the finished NCT01369381 record still lists
NCT01369381 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Endotracheal intubation is the first listed.
NCT01369381 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01369381 about?
NCT01369381 is a clinical study titled "Cervical Spine Biomechanics During Endotracheal Intubation". 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 char...
What is the current status of trial NCT01369381?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2011-12. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01369381?
The interventions under investigation include: Endotracheal intubation (PROCEDURE).
Who is sponsoring clinical trial NCT01369381?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01369381's enrollment target sits among peer trials
14 1909th of 2000 higher than 90 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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