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

Laminectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113723
• Other study ID #: Pro00019845
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2010
• Last updated: February 11, 2016
• Start date: December 2009
• Est. completion date: February 2012

Study information

• Verified date: February 2016
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Laminectomy

Intervention

Device:
• Fiberoptic bronchoscope
Fiberoptic bronchoscope device
• CMAC
CMAC Device

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation Time (Seconds)	Times (seconds) following initial insertion of laryngoscope blade to placement of tracheal tube	3 minutes	No
Primary	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	No
Secondary	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	No