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

Cedars-Sinai Medical Center

Status and phase: Completed; Phase 4

Conditions: Laminectomy

Treatments: Device: CMAC; Device: Fiberoptic bronchoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT01113723

Pro00019845

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

140 participants in 2 patient groups

CMAC Device

Other group

Description:

CMAC Intubating device time to achieve successful tracheal intubation.

Treatment:

Device: CMAC

Fiberoptic bronchoscope

Active Comparator group

Description:

Fiberoptic bronchoscope Intubating device time to achieve successful tracheal intubation.

Treatment:

Device: Fiberoptic bronchoscope