Safety and Efficacy of Endotracheal Intubation Using Glidescope Video-Laryngoscope

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT01683526
First received: September 6, 2012
Last updated: October 9, 2014
Last verified: October 2014
Results First Received: May 23, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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
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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.
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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)

Total Total of all reporting groups

Baseline Measures
    Direct Laryngoscopy     Video Laryngoscopy     Total  
Number of Participants  
[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


No publications provided


Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01683526     History of Changes
Other Study ID Numbers: 139-12
Study First Received: September 6, 2012
Results First Received: May 23, 2014
Last Updated: October 9, 2014
Health Authority: United States: Institutional Review Board