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 11, 2016
Last verified: February 2016
  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
Laminectomy
Device: Fiberoptic bronchoscope
Device: CMAC
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel 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:


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

Primary Outcome Measures:
  • Intubation Time (Seconds) [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    It is the time (in seconds) following initial insertion of laryngoscope blade to confirm with CO2 waveform


Secondary Outcome Measures:
  • Time to Obtain Glottis Visualization (Seconds) [ Time Frame: 1 minute ] [ Designated as safety issue: No ]
    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.


Enrollment: 140
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
CMAC Intubating device time to achieve successful tracheal intubation.
Device: CMAC
CMAC Device
Active Comparator: Fiberoptic bronchoscope
Fiberoptic bronchoscope Intubating device time to achieve successful tracheal intubation.
Device: Fiberoptic bronchoscope
Fiberoptic bronchoscope device

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Results First Received: September 3, 2015
Last Updated: February 11, 2016
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 July 21, 2016