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Comparing Use of the Glidescope Cobalt to Direct Laryngoscopy in Infants

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ClinicalTrials.gov Identifier: NCT01163656
Recruitment Status : Completed
First Posted : July 16, 2010
Results First Posted : January 18, 2013
Last Update Posted : January 31, 2013
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Tracking Information
First Submitted Date  ICMJE July 13, 2010
First Posted Date  ICMJE July 16, 2010
Results First Submitted Date  ICMJE December 13, 2012
Results First Posted Date  ICMJE January 18, 2013
Last Update Posted Date January 31, 2013
Study Start Date  ICMJE July 2010
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 14, 2010)
Time to Tracheal Intubation [ Time Frame: an average time period up to 5 minutes ]
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.
Change History Complete list of historical versions of study NCT01163656 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Use of the Glidescope Cobalt to Direct Laryngoscopy in Infants
Official Title  ICMJE A Prospective Comparison of the Glidescope Cobalt to Standard Direct Laryngoscopy in Infants
Brief Summary The investigators seek to prospectively compare intubation with the Glidescope Cobalt to Direct Laryngoscopy (DL) in infants.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Intubation
Intervention  ICMJE
  • Device: Miller Laryngoscope
    Device is used to facilitate tracheal intubation.
    Other Names:
    • tracheal intubation
    • laryngoscopy
    • direct laryngoscopy
  • 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
Study Arms  ICMJE
  • Active Comparator: Direct Laryngoscopy
    Laryngoscopy will be performed with the randomized device, which will be the Miller Laryngoscope.
    Intervention: Device: Miller Laryngoscope
  • Active Comparator: Glidescope Cobalt Video Laryngoscopy
    Laryngoscopy will be performed with the randomized device, which will be the Glidescope Cobalt Video Laryngoscope.
    Intervention: Device: Glidescope Cobalt Video Laryngoscopes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2013)
66
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2010)
60
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Year   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01163656
Other Study ID Numbers  ICMJE 10-007533
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Hospital of Philadelphia
Study Sponsor  ICMJE Children's Hospital of Philadelphia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Fiadjoe, MD Children's Hospital of Philadelphia
PRS Account Children's Hospital of Philadelphia
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP