Safety and Efficacy of Endotracheal Intubation Using Glidescope Video-Laryngoscope

October 9, 2014 updated by: Beth Israel Medical Center

Safety and Efficacy of Endotracheal Intubation by Pulmonary Critical Care Physicians in Critically-Ill Patients Using Glidescope Video-Laryngoscope

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • Beth Isreal Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Direct laryngoscopy
Intubation will be done using direct laryngoscopy
Procedure: Direct laryngoscopy
Other Names:
  • standard laryngoscope
Active Comparator: Video laryngoscopy
Intubation will be done using video laryngoscopy
Device: Video laryngoscopy (Glidescope)
Other Names:
  • Glidescope Video Laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
First Pass Success Rate
Time Frame: From begining of intubation to verification. Less then 5 minutes approximatly
From begining of intubation to verification. Less then 5 minutes approximatly

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe Desaturation
Time Frame: For 10 minutes post intubation
sat <80%
For 10 minutes post intubation
Hypotension
Time Frame: For 10 minutes post intubation
SBP<70
For 10 minutes post intubation
Cardiac Arrest
Time Frame: For 1 hour post intubation
For 1 hour post intubation
Complications of Intubation
Time Frame: For 10 minutes post intubation
Complications of intubation including aspiration, vomiting, esophageal intubation,and dental injury.
For 10 minutes post intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Medical Center

Investigators

  • Principal Investigator: Michael Silverberg, MD, Beth Israel Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

September 6, 2012

First Submitted That Met QC Criteria

September 11, 2012

First Posted (Estimate)

September 12, 2012

Study Record Updates

Last Update Posted (Estimate)

October 20, 2014

Last Update Submitted That Met QC Criteria

October 9, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 139-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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