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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01113723
First Posted: April 30, 2010
Last Update Posted: March 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
April 23, 2010
April 30, 2010
September 3, 2015
March 9, 2016
March 9, 2016
December 2009
February 2012   (Final data collection date for primary outcome measure)
  • Intubation Time (Seconds) [ Time Frame: 3 minutes ]
    Times (seconds) following initial insertion of laryngoscope blade to placement of tracheal tube
  • Time to Confirm the Placement of the Tracheal Tube [ Time Frame: up tp 3 minutes ]
    It is the time (in seconds) following initial insertion of laryngoscope blade to confirm with CO2 waveform
Intubation time [ Time Frame: 3 minutes ]
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
Time to Obtain Glottis Visualization (Seconds) [ Time Frame: 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.
Glottis visualization using Cormack Lehane and POGO score [ Time Frame: 1 minute ]
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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Laminectomy
  • Device: Fiberoptic bronchoscope
    Fiberoptic bronchoscope device
  • Device: CMAC
    CMAC Device
  • CMAC Device
    CMAC Intubating device time to achieve successful tracheal intubation.
    Intervention: Device: CMAC
  • Active Comparator: Fiberoptic bronchoscope
    Fiberoptic bronchoscope Intubating device time to achieve successful tracheal intubation.
    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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01113723
Pro00019845
Yes
Not Provided
Not Provided
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
February 2016

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