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Safety and Efficacy of Endotracheal Intubation Using Glidescope Video-Laryngoscope

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ClinicalTrials.gov Identifier: NCT01683526
Recruitment Status : Completed
First Posted : September 12, 2012
Results First Posted : June 25, 2014
Last Update Posted : October 20, 2014
Sponsor:
Information provided by (Responsible Party):
Beth Israel Medical Center

Brief Summary:
The safety and efficacy of a video-laryngoscope as a primary intubation tool in urgent endotracheal intubation of critically-ill patients has not been well-described in the literature. This study will answer whether using a VL will impact on the efficacy and safety of intubation compared with a traditional direct laryngoscopy.

Condition or disease Intervention/treatment
Respiratory Failure Procedure: Direct laryngoscopy Device: Video laryngoscopy (Glidescope)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Endotracheal Intubation by Pulmonary Critical Care Physicians in Critically-Ill Patients Using Glidescope Video-Laryngoscope
Study Start Date : August 2012
Primary Completion Date : April 2013
Study Completion Date : April 2013

Arm Intervention/treatment
Active Comparator: Direct laryngoscopy
Intubation will be done using direct laryngoscopy
Procedure: Direct laryngoscopy
Other Name: standard laryngoscope
Active Comparator: Video laryngoscopy
Intubation will be done using video laryngoscopy
Device: Video laryngoscopy (Glidescope)
Other Name: Glidescope Video Laryngoscope



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

Secondary Outcome Measures :
  1. Severe Desaturation [ Time Frame: For 10 minutes post intubation ]
    sat <80%

  2. Hypotension [ Time Frame: For 10 minutes post intubation ]
    SBP<70

  3. Cardiac Arrest [ Time Frame: For 1 hour post intubation ]
  4. Complications of Intubation [ Time Frame: For 10 minutes post intubation ]
    Complications of intubation including aspiration, vomiting, esophageal intubation,and dental injury.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing urgent endotracheal intubation by a pulmonary critical care medicine physician

Exclusion Criteria:

  • Difficult airway
  • Oxygen saturation < 92% despite adequate mask ventilation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683526


Locations
United States, New York
Beth Isreal Medical Center
New York, New York, United States, 10003
Sponsors and Collaborators
Beth Israel Medical Center
Investigators
Principal Investigator: Michael Silverberg, MD Beth Israel Medical Center

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

Keywords provided by Beth Israel Medical Center:
Urgent endotrachel intubation
Direct laryngoscopy
Video laryngoscopy
Glidescope
Critical Care

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases