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

Cedars-Sinai Medical Center140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

140

Conditions

Laminectomy

Interventions

Fiberoptic bronchoscopeDEVICE

Fiberoptic bronchoscope device

CMACDEVICE

CMAC Device

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cedars Sinai Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Intubation Time (Seconds)

Times (seconds) following initial insertion of laryngoscope blade to placement of tracheal tube

Time frame: 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

Time frame: up tp 3 minutes

Secondary Outcomes

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.

Time frame: 1 minute

Data from ClinicalTrials.gov

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