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GlideScope Video Laryngoscope Versus Fiberoptic Intubation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01091948
First Posted: March 24, 2010
Last Update Posted: December 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The Cleveland Clinic
Results First Submitted: June 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Supportive Care
Condition: Oral Intubation
Interventions: Device: Intubation with Fiberoptic laryngoscope
Device: GlideScope® Video Laryngoscope

  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
Active Comparator: Fiberoptic Intubation

Subjects will be intubated with the Fiberoptic laryngoscope.

Active Comparator: GlideScope® Video Laryngoscope Subjects will be intubated with the GlideScope® Video Laryngoscope

GlideScope® Video Laryngoscope

Subjects will be intubated with the GlideScope® Video Laryngoscope.

GlideScope® Video Laryngoscope: Patients will be intubated with the GlideScope® Video Laryngoscope.


Participant Flow:   Overall Study
    Active Comparator: Fiberoptic Intubation   GlideScope® Video Laryngoscope
STARTED   37   38 
COMPLETED   37   38 
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.
No text entered.

Reporting Groups
  Description
Fiberoptic Intubation

Subjects will be intubated with the Fiberoptic laryngoscope.

Intubation with Fiberoptic laryngoscope: Subjects will be intubated with the Fiberoptic laryngoscope.

GlideScope® Video Laryngoscope

Subjects will be intubated with the GlideScope® Video Laryngoscope.

GlideScope® Video Laryngoscope: Patients will be intubated with the GlideScope® Video Laryngoscope.

Total Total of all reporting groups

Baseline Measures
   Fiberoptic Intubation   GlideScope® Video Laryngoscope   Total 
Overall Participants Analyzed 
[Units: Participants]
 37   38   75 
Age 
[Units: Years]
Mean (Standard Deviation)
 54  (11)   52  (16)   53  (13) 
Gender 
[Units: Participants]
Count of Participants
     
Female      18  48.6%      26  68.4%      44  58.7% 
Male      19  51.4%      12  31.6%      31  41.3% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   36   33   69 
Others   1   5   6 
Region of Enrollment 
[Units: Participants]
     
United States   37   38   75 
Weight 
[Units: Kg]
Median (Inter-Quartile Range)
 117 
 (95 to 141) 
 104 
 (93 to 117) 
 110 
 (93 to 126) 
Height 
[Units: Cm]
Mean (Standard Deviation)
 171  (12)   167  (10)   169  (11) 
Body mass index 
[Units: Kg/m^2]
Median (Inter-Quartile Range)
 37 
 (33 to 49) 
 36 
 (34 to 44) 
 37 
 (33 to 46) 
ASA physical status 
[Units: Participants]
     
I: A normal healthy patient   1   3   4 
II: A patient with mild systemic disease   21   18   39 
III: A patient with severe systemic disease   15   17   32 
Modified Mallampati classification [1] 
[Units: Participants]
     
I: Soft palate, uvula, fauces, pillars visible.   7   8   15 
II: Soft palate, uvula, fauces visible.   19   19   38 
III: Soft palate, base of uvula visible.   10   8   18 
IV: Only hard palate visible.   1   2   3 
[1] Modified Mallampati classification was not collected for one patient in the GlideScope Video Laryngoscope group.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Intubation (TTI) as Measured in Seconds   [ Time Frame: from start of intubation to successfully intubated up to 100 seconds ]

2.  Secondary:   Intubation Difficulty Score   [ Time Frame: from start of intubation to successfully intubated ]

3.  Secondary:   Successful Intubation on 1st Attempt   [ Time Frame: from start of first intubation to end of first intubation attempt ]

4.  Secondary:   Occurrence of Hypoxaemia   [ Time Frame: at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after ]

5.  Secondary:   Trace Bleeding   [ Time Frame: Right after intubation ]

6.  Secondary:   Sore Throat Grade   [ Time Frame: On the first postoperative day ]

7.  Secondary:   Number of Intubation Attempts   [ Time Frame: from start of intubation to successfully intubated ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Basem Abdelmalak
Organization: Cleveland Clinic Foundation
phone: 216-444-3746
e-mail: abdelmb@ccf.org



Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01091948     History of Changes
Other Study ID Numbers: 08-079
First Submitted: March 9, 2010
First Posted: March 24, 2010
Results First Submitted: June 20, 2016
Results First Posted: December 20, 2016
Last Update Posted: December 20, 2016