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

Phase 4

Completed

• Conditions: Laminectomy
• Interventions: Device: Fiberoptic bronchoscope; Device: CMAC

• Registration Number: NCT01113723
• Lead Sponsor: Cedars-Sinai Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-28
• Study First Posted: 2010-04-30
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Results First Submitted: 2015-09-03
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-11
• Last Update Submitted: 2016-02-11
• Results First Posted: 2016-03-09
• Last Update Posted: 2016-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fiberoptic bronchoscope	Fiberoptic bronchoscope	Fiberoptic bronchoscope Intubating device time to achieve successful tracheal intubation.
CMAC Device	CMAC	CMAC Intubating device time to achieve successful tracheal intubation.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to Obtain Glottis Visualization (Seconds)	1 minute	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.

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States