GlideScope Spectrum Video Laryngoscope Blades and Stylet for Use in Neonate & Pre-Adolescent Populations

Study Overview
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Brief Summary
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The overall purpose of this study is to assess the functionality & impact of the use of the newly designed GlideScope Spectrum pediatric video laryngoscope and stylet for the orotracheal intubation of neonates and pediatric patients, utilizing manikin models.

Detailed Description
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The overall purpose of this study is to assess the functionality & impact of the use of the newly designed GlideScope Spectrum pediatric video laryngoscope blades and stylet for the orotracheal intubation of neonates and pediatric patients, utilizing manikin models. The hypothesis is that the Spectrum laryngoscope blades and stylet can improve the time and/or success of orotracheal intubation in a manikin. Secondary aims of this study include assessing the impact of Spectrum pediatric video laryngoscope blades under simulated normal and difficult airway conditions on glottic view grade, mouth space, ease of blade insertion, ease of tracheal tube insertion, mechanisms of tracheal tube insertion impediment, and perceived overall clinical & functional usefulness in airways with predictors of difficult intubation.

Official Title
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Assessment of the GlideScope Spectrum Video Laryngoscope Blades and Stylet for Use in Neonate & Pre-Adolescent Populations: Pilot Manikin Study

Conditions
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Pediatric ALL

Intervention / Treatment
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* Device: orotracheal intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anesthesia and emergency medicine providers who perform pediatric orotracheal intubations Able to give voluntary consent to participate in the study Are experienced with orotracheal intubation (> 50 times) using direct laryngoscopy or video laryngoscopy Exclusion Criteria: Volunteers who are < 18 years of age Volunteers unable to read or understand English Unable to physically meet the demands of orotracheal intubation or those who have heart, wrist, or low back disease. Are not experienced with pediatric orotracheal intubations

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants<br>Anesthesia and emergency medicine providers who perform pediatric orotracheal intubations | Device: orotracheal intubation<br>* orotracheal intubation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to intubate | Time to intubate on each of 3 attempts per blade, on each manikin type. | 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. | 
| First pass success rate | First pass success rate on each of 3 attempts per blade, on each manikin type. First pass success (FPS) is defined as the ability to place a tracheal tube below a patient's vocal cords on the first attempt without removing the video laryngoscope from the patient's mouth. | 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. | 
| Overall performance and clinical utility using a 5-point Likert Scale | Overall performance and clinical utility of single-use pediatric stylet; Using a 5-point LIKERT SCALE, participants will grade the following statements with regards to the use of the single-use pediatric stylet = strongly disagree = disagree = neutral = agree = strongly agree e.g. - Participants will assign a number to the following statements: The pediatric style was easy to insert into the mouth of the when used with normal neonate manikin The pediatric style was easy to insert into the mouth of the when used with the difficult neonate manikin The pediatric style was easy to insert into the mouth of the when used with normal pediatric manikin | 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failed intubation attempt | The time taken for an intubation attempt that ultimately fails proper tube placement, or exceeds the allowed time for intubation under this protocol. Failed intubation attempt is defined as an attempt to intubate that does not result in tube placement, that is longer than 120 seconds, or results in a wrong placement of endotracheal tube (For example: Esophageal intubation, etc.). | 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. | 
| Intubation success on first attempt | Cumulative measure of intubation success on first attempt over 3 successive uses of the pediatric video laryngoscope, per blade, on each manikin type. | 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. |