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Safety and Efficacy of Endotracheal Intubation Using Glidescope Video-Laryngoscope

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01683526
First Posted: September 12, 2012
Last Update Posted: October 20, 2014
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):
Beth Israel Medical Center
Results First Submitted: May 23, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Respiratory Failure
Interventions: Procedure: Direct laryngoscopy
Device: Video laryngoscopy (Glidescope)

  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
Direct Laryngoscopy

Intubation will be done using direct laryngoscopy

Direct laryngoscopy

Video Laryngoscopy

Intubation will be done using video laryngoscopy

Video laryngoscopy (Glidescope)


Participant Flow:   Overall Study
    Direct Laryngoscopy   Video Laryngoscopy
STARTED   60   57 
COMPLETED   60   57 
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
Direct Laryngoscopy

Intubation will be done using direct laryngoscopy

Direct laryngoscopy

Video Laryngoscopy

Intubation will be done using video laryngoscopy

Video laryngoscopy (Glidescope)

Total Total of all reporting groups

Baseline Measures
   Direct Laryngoscopy   Video Laryngoscopy   Total 
Overall Participants Analyzed 
[Units: Participants]
 60   57   117 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.6  (15.9)   65.4  (14.0)   67.4  (15.1) 
Gender 
[Units: Participants]
     
Female   26   30   56 
Male   34   27   61 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   First Pass Success Rate   [ Time Frame: From begining of intubation to verification. Less then 5 minutes approximatly ]

2.  Secondary:   Severe Desaturation   [ Time Frame: For 10 minutes post intubation ]

3.  Secondary:   Hypotension   [ Time Frame: For 10 minutes post intubation ]

4.  Secondary:   Cardiac Arrest   [ Time Frame: For 1 hour post intubation ]

5.  Secondary:   Complications of Intubation   [ Time Frame: For 10 minutes post intubation ]


  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: Michael Silverberg
Organization: Beth Israel Medical center
phone: 2124202377
e-mail: msilverberg2@chpnet.org



Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01683526     History of Changes
Other Study ID Numbers: 139-12
First Submitted: September 6, 2012
First Posted: September 12, 2012
Results First Submitted: May 23, 2014
Results First Posted: June 25, 2014
Last Update Posted: October 20, 2014