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Comparison of Direct Laryngoscopy, Truview EVO2 and Glidescope in Pediatric Patients

This study has been terminated.
(The study was stopped for futility at the first interim analysis)
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01023568
First received: December 1, 2009
Last updated: December 8, 2016
Last verified: December 2016
Results First Received: June 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Supportive Care
Condition: Intubation
Interventions: Device: Macintosh blade
Device: Glidescope
Device: Truview PCD

  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
No text entered.

Reporting Groups
  Description
Macintosh Blade

Intubation with Macintosh blade laryngoscope

Macintosh blade: Intubation with Macintosh blade laryngoscope

Glidescope

Intubation with Glidescope laryngoscope

Glidescope: Intubation with Glidescope laryngoscope.

Truview PCD

Intubation with the Truview PCD laryngoscope

Truview PCD: Intubation with Truview PCD laryngoscope.


Participant Flow:   Overall Study
    Macintosh Blade   Glidescope   Truview PCD
STARTED   45   44   45 
COMPLETED   45   44   45 
NOT COMPLETED   0   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
Macintosh Blade

Intubation with Macintosh blade laryngoscope

Macintosh blade: Intubation with Macintosh blade laryngoscope

Glidescope

Intubation with Glidescope laryngoscope

Glidescope: Intubation with Glidescope laryngoscope.

Truview PCD

Intubation with the Truview PCD laryngoscope

Truview PCD: Intubation with Truview PCD laryngoscope.

Total Total of all reporting groups

Baseline Measures
   Macintosh Blade   Glidescope   Truview PCD   Total 
Overall Participants Analyzed 
[Units: Participants]
 45   44   45   134 
Age 
[Units: Years]
Mean (Standard Deviation)
 4.0  (2.8)   4.6  (2.7)   5.2  (2.8)   4.6  (2.8) 
Gender 
[Units: Participants]
Count of Participants
       
Female      16  35.6%      11  25.0%      14  31.1%      41  30.6% 
Male      29  64.4%      33  75.0%      31  68.9%      93  69.4% 
Body mass index 
[Units: Kg/m2]
Median (Inter-Quartile Range)
 17 
 (15 to 19) 
 16 
 (15 to 18) 
 16 
 (16 to 18) 
 16.5 
 (15.4 to 18.8) 
ASA physical status 
[Units: Participants]
       
I: A normal healthy patient   19   20   19   58 
II: A patient with mild systemic disease   24   23   25   72 
III: A patient with severe systemic disease   2   1   1   4 


  Outcome Measures
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1.  Primary:   Time to Successfully Intubate Patient.   [ Time Frame: from start of intubation to successfully intubated up to 5 minutes ]

2.  Secondary:   Mean Hemodynamic Response: Mean Arterial Blood Pressure   [ Time Frame: measured at 1 minute interval at induction time and from intubation for 10 minutes ]

3.  Secondary:   Cormack-Lehane Grade   [ Time Frame: immediately after intubation ]

4.  Secondary:   Mean Hemodynamic Response: Heart Rate   [ Time Frame: measured at 1 minute interval at induction time and from intubation for 10 minutes. ]

5.  Secondary:   Number of Participants Who Experienced Desaturation   [ Time Frame: measured at 1 minute interval at induction time and from intubation for 10 minutes. ]


  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: Roberta Johnson
Organization: Cleveland Clinic
phone: 216-444-9950
e-mail: johnsor13@ccf.org



Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01023568     History of Changes
Other Study ID Numbers: 09-902
Study First Received: December 1, 2009
Results First Received: June 21, 2016
Last Updated: December 8, 2016