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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: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Respiratory Failure
 Procedure: Direct laryngoscopy
Device: Video laryngoscopy (Glidescope)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • First pass success rate [ Time Frame: From begining of intubation to verification. Less then 5 minutes approximatly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Severe desaturation [ Time Frame: For 10 minutes post intubation ] [ Designated as safety issue: Yes ]
    sat <80%

  • Hypotension [ Time Frame: For 10 minutes post intubation ] [ Designated as safety issue: Yes ]
    SBP<70

  • Cardiac arrest [ Time Frame: For 1 hour post intubation ] [ Designated as safety issue: Yes ]
  • Complications of intubation [ Time Frame: For 10 minutes post intubation ] [ Designated as safety issue: Yes ]
    Complications of intubation including aspiration, vomiting, esophageal intubation,and dental injury.


Enrollment: 117
Study Start Date: August 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683526

Locations
United States, New York
Beth Isreal Medical Center
New York, New York, United States, 10003
Sponsors and Collaborators
Beth Israel Medical Center
  More Information

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
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013