This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Participant)
Condition: Laminectomy
Interventions: Device: Fiberoptic bronchoscope
Device: CMAC

  Participant Flow
  Hide 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
No text entered.

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
  Hide 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.
No text entered.

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 
Overall Participants Analyzed 
[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
  Show All 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
  Hide 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
No text entered.


  More Information
  Hide 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
Study First Received: April 23, 2010
Results First Received: September 3, 2015
Last Updated: February 11, 2016