Clinical trial NCT01488370: Comparison of 2 Laryngoscopes for Endotracheal Intubation in Children Younger Than 2 Years Old
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Intubation
Keywords: breathing tube placement
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2011-12-08
Enrollment: 65
Sex: ALL
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia
Secondary outcomes:
measure: Successful Intubation After One Laryngoscopy Attempt
timeFrame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.
measure: Successful Intubation After Two Laryngoscopy Attempts
timeFrame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.
measure: Successful Intubation After Three Laryngoscopy Attempts
timeFrame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.
measure: Successful Intubation After Four Laryngoscopy Attempts
timeFrame: Through endotracheal intubation during induction of general anesthesia, an average of 10 minutes
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Department of Anesthesiology
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Loma Linda University Department of Anesthesiology
name: Elizabeth Ghazal, MD
role: PRINCIPAL_INVESTIGATOR
References: