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
Results First Received: September 3, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject)
Condition: Laminectomy
Interventions: Device: Fiberoptic bronchoscope
Device: CMAC

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
CMAC Device

CMAC

CMAC: CMAC Device

Fiberoptic Bronchoscope Fiberoptic bronchoscope device: the flexible fiberoptic scope (FFS)

Participant Flow:   Overall Study
    CMAC Device     Fiberoptic Bronchoscope  
STARTED     70     70  
COMPLETED     70     70  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
CMAC Device

CMAC

CMAC: CMAC Device

Fiberoptic Bronchoscope

Fiberoptic bronchoscope

Fiberoptic bronchoscope: Fiberoptic bronchoscope device

Total Total of all reporting groups

Baseline Measures
    CMAC Device     Fiberoptic Bronchoscope     Total  
Number of Participants  
[units: participants]
  70     70     140  
Age  
[units: years]
Mean (Standard Deviation)
  55  (12)     50  (12)     53  (12)  
Gender  
[units: participants]
     
Female     32     38     70  
Male     38     32     70  
Region of Enrollment  
[units: participants]
     
United States     70     70     140  



  Outcome Measures
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1.  Primary:   Intubation Time (Seconds)   [ Time Frame: 3 minutes ]

2.  Primary:   Time to Confirm the Placement of the Tracheal Tube   [ Time Frame: up tp 3 minutes ]

3.  Secondary:   Time to Obtain Glottis Visualization (Seconds)   [ Time Frame: 1 minute ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Roya Yumul, M.D., Ph.D.
Organization: Department of Anesthesiology, Cedars-Sinai Medical Center
phone: 310-423-5841
e-mail: (Roya.Yumul@cshs.org)



Responsible Party: Roya Yumul, M.D.,PhD., 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