Comparing Use of the Glidescope Cobalt to Direct Laryngoscopy in Infants

Study Overview
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Brief Summary
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The investigators seek to prospectively compare intubation with the Glidescope Cobalt to Direct Laryngoscopy (DL) in infants.

Detailed Description
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We seek to study the intubation characteristics of a new video laryngoscope, the Glidescope Cobalt in children less than or equal to 1 yr of age. This evaluation would provide insight as to the efficacy of this device in facilitating intubation in infants.

Official Title
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A Prospective Comparison of the Glidescope Cobalt to Standard Direct Laryngoscopy in Infants

Conditions
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Intubation

Intervention / Treatment
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* Device: Miller Laryngoscope
* Device: Glidescope Cobalt Video Laryngoscopes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to undergo elective surgery at CHOP American Society of Anesthesiologists (ASA) Physical Status I or II Anesthetic plan requiring tracheal intubation with a neuromuscular relaxant Parental/guardian permission (informed consent). Subjects will be too young to understand the study procedures and therefore assent will not be sought. - Exclusion Criteria: At known or anticipated high risk for aspiration pneumonia Known or predicted difficult intubation as assessed by the clinical attending anesthesiologist Emergency surgical procedure Patients with preoperative airway pathology or stridor -

Ages Eligible for Study
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Maximum Age: 1 Year

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct Laryngoscopy<br>Laryngoscopy will be performed with the randomized device, which will be the Miller Laryngoscope. | Device: Miller Laryngoscope<br>* Device is used to facilitate tracheal intubation.<br>* Other names: direct laryngoscopy;|
| Active Comparator: Glidescope Cobalt Video Laryngoscopy<br>Laryngoscopy will be performed with the randomized device, which will be the Glidescope Cobalt Video Laryngoscope. | Device: Glidescope Cobalt Video Laryngoscopes<br>* The laryngoscope design with the integration of video technology into the laryngoscope blade.<br>* Other names: Video Laryngoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Tracheal Intubation | The amount of time it takes the anesthesiologist to insert a breathing tube using one of two methods, either by direct laryngoscopy or using the Glidescope Cobalt Video system. | Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonate, Laryngoscopes