Intubation of Patients With an Unstable Cervical Spine Using the CMAC Device

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Prospective Study to Compare Tracheal Intubation With the CMAC Device to Fiberoptic Bronchoscopy in Patients With an Unstable Cervical Spine

Conditions
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Laminectomy

Intervention / Treatment
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* Device: Fiberoptic bronchoscope
* Device: CMAC


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CMAC Device<br>CMAC Intubating device time to achieve successful tracheal intubation. | Device: CMAC<br>* CMAC Device<br>|
| Active Comparator: Fiberoptic bronchoscope<br>Fiberoptic bronchoscope Intubating device time to achieve successful tracheal intubation. | Device: Fiberoptic bronchoscope<br>* Fiberoptic bronchoscope device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation Time (Seconds) | Times (seconds) following initial insertion of laryngoscope blade to placement of tracheal tube | 3 minutes | 
| Time to Confirm the Placement of the Tracheal Tube | It is the time (in seconds) following initial insertion of laryngoscope blade to confirm with CO2 waveform | up tp 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Obtain Glottis Visualization (Seconds) | Time to Obtain Glottis Visualization (Seconds): View of the glottis during the beginning of the intubation procedure. (approximately 1 minute) Glottic (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the two devices in patients with an unstable cervical spine. | 1 minute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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C-MAC, Fiberoptic bronchoscope, Laryngoscopy, Cervical spine injury, Glottic view, Tracheal intubation