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Comparison of 2 Laryngoscopes for Endotracheal Intubation in Children Younger Than 2 Years Old

This study is currently recruiting participants.
Verified March 2013 by Loma Linda University
Sponsor:
Information provided by (Responsible Party):
Elizabeth Ghazal, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01488370
First received: November 1, 2011
Last updated: March 27, 2013
Last verified: March 2013
History of Changes
  Purpose

This is a prospective randomized clinical study to be performed in pediatric patients under the age of 2 years who are undergoing surgical procedures requiring endotracheal intubation. Time to endotracheal intubation will be compared between patients intubated using a GlideScope® video laryngoscope, those intubated with a Storz DCI® video laryngoscope, and those intubated by standard direct laryngoscopy. The study hypothesis is that the time to endotracheal intubation will be decreased in the Storz DCI® video laryngoscope group when compared to the GlideScope® video laryngoscope group and standard laryngoscopy.


Condition Intervention
Endotracheal Intubation
 Device: Endotracheal intubation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Comparison of the Glidescope® Video Laryngoscope and the Storz DCI® Video Laryngoscope for Endotracheal Intubation in Children Younger Than Two Years of Age

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Measurement of time to intubation will begin at the time of mouth opening and end with the removal of the tip of the laryngoscope blade from the patient's mouth after successful endotracheal intubation. [ Time Frame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome measures will be the number of laryngoscopy attempts required for successful intubation. [ Time Frame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia. ] [ Designated as safety issue: No ]
    Other secondary outcome measures will be the use of external laryngeal manipulation to improve glottic view, tissue trauma and type,and method of rescue if initial intubation attempt proves unsuccessful.


Estimated Enrollment: 75
Study Start Date: November 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Glidescope
A device for endotracheal intubation.
 Device: Endotracheal intubation
Endotracheal intubation
Other Names:
  • Storz DCI video laryngoscope
  • Glidescope video laryngoscope
Active Comparator: Storz
A device for endotracheal intubation.
 Device: Endotracheal intubation
Endotracheal intubation
Other Names:
  • Storz DCI video laryngoscope
  • Glidescope video laryngoscope
Active Comparator: Standard Laryngoscope
A device for endotracheal intubation
 Device: Endotracheal intubation
Endotracheal intubation
Other Names:
  • Storz DCI video laryngoscope
  • Glidescope video laryngoscope

  Eligibility

Ages Eligible for Study:   up to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric patients under the age of 2 years undergoing surgeries requiring endotracheal intubation at LLUMC will be eligible for participation in this study

Exclusion Criteria:

  • Children with increased pulmonary aspiration risk;
  • Prior documentation of difficult endotracheal intubation;
  • Those that lack legal representative consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488370

Contacts
Contact: Elizabeth Ghazal, MD 909-558-4475 eghazal@llu.edu
Contact: Patricia Moore 909-558-8493 pamoore@llu.edu

Locations
United States, California
Loma Linda University Department of Anesthesiology Not yet recruiting
Loma Linda, California, United States, 92354
Contact: Elizabeth Ghazal, MD         eghazal@llu.edu    
Contact: Patricia Moore     909-558-8493     pamoore@llu.edu    
Principal Investigator: Elizabeth Ghazal, MD            
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Elizabeth A Ghazal, MD     909-558-8493     eghazal@llu.edu    
Contact: Pat Moore     909 558 8493     pamoore@llu.edu    
Principal Investigator: Elizabeth A Ghazal, MD            
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Elizabeth Ghazal, MD Loma Linda University Department of Anesthesiology
  More Information

No publications provided

Responsible Party: Elizabeth Ghazal, MD, Loma Linda University
ClinicalTrials.gov Identifier: NCT01488370     History of Changes
Other Study ID Numbers: 5110244
Study First Received: November 1, 2011
Last Updated: March 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
breathing tube placement

ClinicalTrials.gov processed this record on May 23, 2013