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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: February 14, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cervical Vertebrae
 Device: Fiberoptic bronchoscope
Device: CMAC
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Official Title: A Randomized Prospective Study to Compare Tracheal Intubation With the CMAC Device to Fiberoptic Bronchoscopy in Patients With an Unstable Cervical Spine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 128
Study Start Date: December 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CMAC Device Device: CMAC
CMAC Device
Active Comparator: Fiberoptic bronchoscope Device: Fiberoptic bronchoscope
Fiberoptic bronchoscope device

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113723

Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Roya Yumul, MD, PhD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Roya Yumul, M.D.,PhD., Residency program director, Department of anesthesiology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01113723     History of Changes
Other Study ID Numbers: Pro00019845
Study First Received: April 23, 2010
Last Updated: February 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
C-MAC
Fiberoptic bronchoscope
Laryngoscopy
 Cervical spine injury
Glottic view
Tracheal intubation

ClinicalTrials.gov processed this record on May 19, 2013