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Comparing Use of the Glidescope Cobalt to Direct Laryngoscopy in Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01163656
First Posted: July 16, 2010
Last Update Posted: January 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
  Purpose
The investigators seek to prospectively compare intubation with the Glidescope Cobalt to Direct Laryngoscopy (DL) in infants.

Condition Intervention
Intubation Device: Miller Laryngoscope Device: Glidescope Cobalt Video Laryngoscopes

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Comparison of the Glidescope Cobalt to Standard Direct Laryngoscopy in Infants

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • 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.


Enrollment: 66
Study Start Date: July 2010
Study Completion Date: March 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • tracheal intubation
  • laryngoscopy
  • direct 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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
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): NCT01163656


Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: John Fiadjoe, MD Children's Hospital of Philadelphia
  More Information

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01163656     History of Changes
Other Study ID Numbers: 10-007533
First Submitted: July 13, 2010
First Posted: July 16, 2010
Results First Submitted: December 13, 2012
Results First Posted: January 18, 2013
Last Update Posted: January 31, 2013
Last Verified: January 2013

Keywords provided by Children's Hospital of Philadelphia:
Neonate
Laryngoscopes

Additional relevant MeSH terms:
Cobalt
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs