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Safety and Efficacy of Endotracheal Intubation Using Glidescope Video-Laryngoscope

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Direct laryngoscopy
Video laryngoscopy (Glidescope)
Sponsored by
Beth Israel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring Urgent endotrachel intubation, Direct laryngoscopy, Video laryngoscopy, Glidescope, Critical Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Isreal Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Direct laryngoscopy

Video laryngoscopy

Arm Description

Intubation will be done using direct laryngoscopy

Intubation will be done using video laryngoscopy

Outcomes

Primary Outcome Measures

First Pass Success Rate

Secondary Outcome Measures

Severe Desaturation
sat <80%
Hypotension
SBP<70
Cardiac Arrest
Complications of Intubation
Complications of intubation including aspiration, vomiting, esophageal intubation,and dental injury.

Full Information

First Posted
September 6, 2012
Last Updated
October 9, 2014
Sponsor
Beth Israel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01683526
Brief Title
Safety and Efficacy of Endotracheal Intubation Using Glidescope Video-Laryngoscope
Official Title
Safety and Efficacy of Endotracheal Intubation by Pulmonary Critical Care Physicians in Critically-Ill Patients Using Glidescope Video-Laryngoscope
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
Urgent endotrachel intubation, Direct laryngoscopy, Video laryngoscopy, Glidescope, Critical Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Direct laryngoscopy
Arm Type
Active Comparator
Arm Description
Intubation will be done using direct laryngoscopy
Arm Title
Video laryngoscopy
Arm Type
Active Comparator
Arm Description
Intubation will be done using video laryngoscopy
Intervention Type
Procedure
Intervention Name(s)
Direct laryngoscopy
Other Intervention Name(s)
standard laryngoscope
Intervention Type
Device
Intervention Name(s)
Video laryngoscopy (Glidescope)
Other Intervention Name(s)
Glidescope Video Laryngoscope
Primary Outcome Measure Information:
Title
First Pass Success Rate
Time Frame
From begining of intubation to verification. Less then 5 minutes approximatly
Secondary Outcome Measure Information:
Title
Severe Desaturation
Description
sat <80%
Time Frame
For 10 minutes post intubation
Title
Hypotension
Description
SBP<70
Time Frame
For 10 minutes post intubation
Title
Cardiac Arrest
Time Frame
For 1 hour post intubation
Title
Complications of Intubation
Description
Complications of intubation including aspiration, vomiting, esophageal intubation,and dental injury.
Time Frame
For 10 minutes post intubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Silverberg, MD
Organizational Affiliation
Beth Israel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Isreal Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

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Safety and Efficacy of Endotracheal Intubation Using Glidescope Video-Laryngoscope

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