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

Study Overview
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Brief Summary
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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.

Official Title
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A Comparison of the Glidescope® Video Laryngoscope and the Storz DCI® Video Laryngoscope for Endotracheal Intubation in Children Younger Than Two Years of Age

Conditions
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Endotracheal Intubation

Intervention / Treatment
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* Device: Endotracheal intubation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 23 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glidescope<br>A device for endotracheal intubation. | Device: Endotracheal intubation<br>* Endotracheal intubation<br>* Other names: Glidescope video laryngoscope;|
| Active Comparator: Storz<br>A device for endotracheal intubation. | Device: Endotracheal intubation<br>* Endotracheal intubation<br>* Other names: Glidescope video laryngoscope;|
| Active Comparator: Standard Laryngoscope<br>A device for endotracheal intubation | Device: Endotracheal intubation<br>* Endotracheal intubation<br>* Other names: Glidescope video laryngoscope;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Intubation After One Laryngoscopy Attempt | 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. | Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia. | 
| Successful Intubation After Two Laryngoscopy Attempts |  | 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 |  | 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 |  | Through endotracheal intubation during induction of general anesthesia, an average of 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breathing tube placement