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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01113723
First received: April 23, 2010
Last updated: November 13, 2013
Last verified: November 2013

April 23, 2010
November 13, 2013
December 2009
February 2012   (final data collection date for primary outcome measure)
Intubation time [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]
Start to end of intubation procedure (approximately 3 minutes) Evaluate whether tracheal intubation with the CMAC device decreases the time between intubation instrumentation in patients with an unstable cervical spine.
Intubation time [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]
Start to end of intubation procedure (approximatly 3 minutes) Evaluate whether tracheal intubation with the CMAC device decreases the time between intubation instrumentation in patients with an unstable cervical spine.
Complete list of historical versions of study NCT01113723 on ClinicalTrials.gov Archive Site
Glottis visualization using Cormack Lehane and POGO score [ Time Frame: 1 minute ] [ Designated as safety issue: No ]
Start of 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.
Glottis visualization using Cormack Lehane and POGO score [ Time Frame: 1 minute ] [ Designated as safety issue: No ]
Start of intubation procedure (approximatly 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.
Not Provided
Not Provided
 
Intubation of Patients With an Unstable Cervical Spine Using the CMAC Device
A Randomized Prospective Study to Compare Tracheal Intubation With the CMAC Device to Fiberoptic Bronchoscopy in Patients With an Unstable Cervical Spine

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Cervical Vertebrae
  • Device: Fiberoptic bronchoscope
    Fiberoptic bronchoscope device
  • Device: CMAC
    CMAC Device
  • CMAC Device
    Intervention: Device: CMAC
  • Active Comparator: Fiberoptic bronchoscope
    Intervention: Device: Fiberoptic bronchoscope
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01113723
Pro00019845
Yes
Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
Not Provided
Principal Investigator: Roya Yumul, MD, PhD Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP