Comparing Use of the Glidescope Cobalt to Direct Laryngoscopy in Infants

January 24, 2013 updated by: Children's Hospital of Philadelphia

A Prospective Comparison of the Glidescope Cobalt to Standard Direct Laryngoscopy in Infants

The investigators seek to prospectively compare intubation with the Glidescope Cobalt to Direct Laryngoscopy (DL) in infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We seek to study the intubation characteristics of a new video laryngoscope, the Glidescope Cobalt in children less than or equal to 1 yr of age. This evaluation would provide insight as to the efficacy of this device in facilitating intubation in infants.

Study Type

Interventional

Enrollment (Actual)

66

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia

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

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Scheduled to undergo elective surgery at CHOP
  2. American Society of Anesthesiologists (ASA) Physical Status I or II
  3. Anesthetic plan requiring tracheal intubation with a neuromuscular relaxant
  4. Parental/guardian permission (informed consent). Subjects will be too young to understand the study procedures and therefore assent will not be sought. -

Exclusion Criteria:

  1. At known or anticipated high risk for aspiration pneumonia
  2. Known or predicted difficult intubation as assessed by the clinical attending anesthesiologist
  3. Emergency surgical procedure
  4. Patients with preoperative airway pathology or stridor -

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
Laryngoscopy will be performed with the randomized device, which will be the Miller Laryngoscope.
Device: Miller Laryngoscope
Device is used to facilitate tracheal intubation.
Other Names:
  • direct laryngoscopy
  • tracheal intubation
  • laryngoscopy
Active Comparator: Glidescope Cobalt Video Laryngoscopy
Laryngoscopy will be performed with the randomized device, which will be the Glidescope Cobalt Video Laryngoscope.
Device: Glidescope Cobalt Video Laryngoscopes
The laryngoscope design with the integration of video technology into the laryngoscope blade.
Other Names:
  • Glidescope Cobalt Video Laryngoscopy
  • Video Laryngoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Tracheal Intubation
Time Frame: Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation.
The amount of time it takes the anesthesiologist to insert a breathing tube using one of two methods, either by direct laryngoscopy or using the Glidescope Cobalt Video system.
Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation.

Collaborators and Investigators

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

Sponsor

Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: John Fiadjoe, MD, Children's Hospital of Philadelphia

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

July 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

July 13, 2010

First Submitted That Met QC Criteria

July 14, 2010

First Posted (Estimate)

July 16, 2010

Study Record Updates

Last Update Posted (Estimate)

January 31, 2013

Last Update Submitted That Met QC Criteria

January 24, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-007533

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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