Comparison of Direct Laryngoscopy, Truview EVO2 and Glidescope in Pediatric Patients

Study Overview
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Brief Summary
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The purpose of this study is to compare the effectiveness of two novel videolaryngoscope systems, the Glidescope and the Truview PCD against standard direct laryngoscopy (DL) in pediatric patients. The investigators primary hypothesis is that the use of videolaryngoscope devices, Glidescope and Truview provide better laryngeal views in pediatric patients as measured by Cormack and ehane (C&L) (1 to 4, 4 the worst), without increasing the time taken to intubate (TTI), compared with direct laryngoscopy (DL). The investigators secondary hypotheses are that the use of Glidescope and Truview PCD provoke less hemodynamic response and fewer episodes of de-saturation in pediatric patients.

Detailed Description
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Advances in airway management have led to development on videolaryngoscopy devices including the Glidescope® (Verathon Inc, Bothwell, USA), the AWD® (Pentax Corporation, Tokio, Japan) and most recently the Truview PCD (Truphatek International Ltd, Netanya, Israel). The use of videolaryngoscopy devices in adults have demonstrated some advantages including, minimal trauma on the airway and better view of the glottis. The Glidescope is designed with a 60º angle and a camera on the inferior aspect just at the inflection point. The view is obtained anteriorly and the camera is located remote from the glottis providing a good visual field. The video image is displayed on a Liquid Crystal Display (LCD), with electronic recording available. Despite a good experience using Glidescope in adults, few studies have been published in pediatric patients. Kim et al. in a randomized study comparing the use of Glidescope with direct laryngoscopy in children, demonstrated better or equal laryngoscopic view with longer time for intubation using the Glidescope.

Official Title
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Comparison of Direct Laryngoscopy, Truview EVO2 and Glidescope in Pediatric Patients

Conditions
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Intubation

Intervention / Treatment
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* Device: Macintosh blade
* Device: Glidescope
* Device: Truview PCD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status I-III elective general surgical procedures from 0-10 years-old Exclusion Criteria: increase intracranial pressure history of severe gastrointestinal reflux sore throat upper respiratory airway infection known or suspected difficult airway or coagulopathy

Ages Eligible for Study
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Maximum Age: 10 Years

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Macintosh blade<br>Intubation with Macintosh blade laryngoscope | Device: Macintosh blade<br>* Intubation with Macintosh blade laryngoscope<br>|
| Active Comparator: Glidescope<br>Intubation with Glidescope laryngoscope | Device: Glidescope<br>* Intubation with Glidescope laryngoscope.<br>|
| Active Comparator: Truview PCD<br>Intubation with the Truview PCD laryngoscope | Device: Truview PCD<br>* Intubation with Truview PCD laryngoscope.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Successfully Intubate Patient. |  | from start of intubation to successfully intubated up to 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Hemodynamic Response: Mean Arterial Blood Pressure |  | measured at 1 minute interval at induction time and from intubation for 10 minutes | 
| Cormack-Lehane Grade |  | immediately after intubation | 
| Mean Hemodynamic Response: Heart Rate |  | measured at 1 minute interval at induction time and from intubation for 10 minutes. | 
| Number of Participants Who Experienced Desaturation | Desaturation was defined as SpO2 less than 90% at induction time or any time from intubation to 10 minutes after | measured at 1 minute interval at induction time and from intubation for 10 minutes. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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videolaryngoscope devices, intubation, pediatric