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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elizabeth Ghazal, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01488370
First received: November 1, 2011
Last updated: April 14, 2017
Last verified: April 2017
  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 (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 Elizabeth Ghazal, 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 ]

Secondary Outcome Measures:
  • Successful Intubation After One Laryngoscopy Attempt [ Time Frame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia. ]
    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.

  • Successful Intubation After Two Laryngoscopy Attempts [ Time Frame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia. ]
  • Successful Intubation After Three Laryngoscopy Attempts [ Time Frame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia. ]
  • Successful Intubation After Four Laryngoscopy Attempts [ Time Frame: Through endotracheal intubation during induction of general anesthesia, an average of 10 minutes ]

Enrollment: 65
Study Start Date: November 2011
Study Completion Date: July 2015
Primary Completion Date: July 2015 (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   (Child)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488370

Locations
United States, California
Loma Linda University Department of Anesthesiology
Loma Linda, California, United States, 92354
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Elizabeth Ghazal, MD Loma Linda University Department of Anesthesiology
  More Information

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
Results First Received: December 8, 2016
Last Updated: April 14, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Elizabeth Ghazal, Loma Linda University:
breathing tube placement

ClinicalTrials.gov processed this record on September 21, 2017