Phase 4
N=140
Intubation of Patients With an Unstable Cervical Spine Using the CMAC Device
Laminectomy
Bottom Line
View on ClinicalTrials.gov: NCT01113723 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Intubation Time (Seconds) — 35; 59 Seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fiberoptic bronchoscope (Device); CMAC (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intubation Time (Seconds) |
35; 59 | — |
| PRIMARY Time to Confirm the Placement of the Tracheal Tube |
62; 99 | — |
| SECONDARY Time to Obtain Glottis Visualization (Seconds) |
32; 16 | — |
Summary
The purpose of this study is to evaluate whether tracheal intubation with the CMAC device decreases the time required for intubation as compared to intubation with the fiberoptic bronchoscope in patients with an unstable cervical spine. Both the CMAC device and the fiberoptic bronchoscope are currently commonly used in standard of care practices in the intubation of patients with cervical spine injury.
Eligibility Criteria
Inclusion Criteria
- Patients with an unstable Cervical-spine as a result of C-spine injury.
- Patients scheduled to undergo inpatient surgical procedures under general anesthesia.
- Willingness and ability to sign an informed consent document.
- 18-80 years of age.
- ASA Class I - III adults of either sex
Exclusion Criteria
- Patients deemed to be at significant airway risk to necessitate awake fiber optic intubation.
- Patients with a history of oral-pharyngeal cancer or reconstructive surgery.
- Emergency surgeries.
- Any other conditions which may interfere with the conduct of the study.
Data sourced from ClinicalTrials.gov (NCT01113723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.