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

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ClinicalTrials.gov Identifier: NCT01113723
Recruitment Status : Completed
First Posted : April 30, 2010
Results First Posted : March 9, 2016
Last Update Posted : March 9, 2016
Information provided by (Responsible Party):
Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant)
Condition: Laminectomy
Interventions: Device: Fiberoptic bronchoscope
Device: CMAC

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
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 

  Baseline Characteristics

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
CMAC Device



Fiberoptic Bronchoscope

Fiberoptic bronchoscope

Fiberoptic bronchoscope: Fiberoptic bronchoscope device

Total Total of all reporting groups

Baseline Measures
   CMAC Device   Fiberoptic Bronchoscope   Total 
Overall Participants Analyzed 
[Units: Participants]
 70   70   140 
[Units: Years]
Mean (Standard Deviation)
 55  (12)   50  (12)   53  (12) 
[Units: Participants]
Female   32   38   70 
Male   38   32   70 
Region of Enrollment 
[Units: Participants]
United States   70   70   140 

  Outcome Measures

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

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

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
First Submitted: April 23, 2010
First Posted: April 30, 2010
Results First Submitted: September 3, 2015
Results First Posted: March 9, 2016
Last Update Posted: March 9, 2016