GlideScope®Video Laryngoscope for Difficult Intubation: Implication of the Size of Blade

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01616771
First received: April 30, 2012
Last updated: November 3, 2014
Last verified: November 2014
Results First Received: November 21, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Intubation; Difficult
Interventions: Device: Macintosh laryngoscope
Device: GVL selected by weight
Device: smaller sized GVL

  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
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
  Description
Glottis View Assessment After checking the C&L grade using Macintosh laryngoscope, C&L grade was re-evaluated using GVL selected by weight and smaller sized GVL in consecutive order.

Participant Flow for 3 periods

Period 1:   Macintosh Laryngoscopy for 5 Sec
    Glottis View Assessment  
STARTED     23  
COMPLETED     23  
NOT COMPLETED     0  

Period 2:   GVL Selected by Weight for 5 Sec
    Glottis View Assessment  
STARTED     23  
COMPLETED     23  
NOT COMPLETED     0  

Period 3:   Smaller Sized GVL for 5 Sec
    Glottis View Assessment  
STARTED     23 [1]
COMPLETED     19  
NOT COMPLETED     4  
lack of GVL size                 4  
[1] Four of 23 patients could not be evaluated by smaller sized GVL, because there was no smaller one.



  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
Glottis View Assessment After checking the C&L grade using Macintosh laryngoscope, C&L grade was re-evaluated using GVL selected by weight and smaller sized GVL in consecutive order.

Baseline Measures
    Glottis View Assessment  
Number of Participants  
[units: participants]
  23  
Age  
[units: participants]
 
<=18 years     23  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  7.9  ± 4.8  
Gender  
[units: participants]
 
Female     10  
Male     13  



  Outcome Measures
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1.  Primary:   The Differences in the Glottis View (C&L Grade) of Macintosh Laryngoscope and GVL Selected by Weight.   [ Time Frame: up to 1 day of surgery ]

2.  Secondary:   The Differences in the Glottis View (C&L Grade) of GVL Selected by Weight and Smaller Sized GVL   [ Time Frame: up to 1day of surgery ]


  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: Jin-Tae Kim
Organization: Seoul National University Hospital
phone: 82-10-6260-8490
e-mail: jintae73@gmail.com


No publications provided


Responsible Party: Jin-Tae Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01616771     History of Changes
Other Study ID Numbers: H-1111-037-385
Study First Received: April 30, 2012
Results First Received: November 21, 2013
Last Updated: November 3, 2014
Health Authority: Korea: Food and Drug Administration