A Comparison of the Infant Truview EVO2 Video Laryngoscope and the Macintosh Laryngoscope in Pediatric Patients

Study Overview
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Brief Summary
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This study is intended to examine the effectiveness of a new type of laryngoscope, the Truview EVO2, in an infant patient population. They device will be tested against the current clinical standard, the Macintosh laryngoscope, in patients undergoing surgery at our hospital in terms of ease of use, view obtained of the vocal cords, and ability to place an endotracheal tube.

Official Title
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A Comparison of the Infant Truview EVO2 Video Laryngoscope and the Macintosh Laryngoscope in Pediatric Patients

Conditions
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Laryngoscopy

Intervention / Treatment
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* Device: Truview EVO2 laryngoscope
* Device: Macintosh laryngoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age less than one year Requiring general anesthesia and orotracheal intubation Weight less than 10 kg ASA class 1-3 Exclusion Criteria: Documented difficult airway Facial deformities

Ages Eligible for Study
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Maximum Age: 12 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Truview intubation<br>Receive laryngoscopy with Truview first and is immediately followed by laryngoscopy and intubation with Macintosh | Device: Truview EVO2 laryngoscope<br>* will use the Truview laryngoscope instead of the traditional Macintosh laryngoscope<br>|
| Active Comparator: Macintosh intubation<br>Macintosh blade will be used first followed by laryngoscopy and intubation with the truview | Device: Macintosh laryngoscope<br>* Intubation using the traditional Macintosh laryngoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Laryngeal View Obtained on Comarck Lehane Classification | The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible. | during laryngoscopy prior to intubation. Few minutes before intubation | 
| Number of Intubation Attempts | Number of participants with the indicated number of intubation attempts (1/2/3) | during intubation prior to surgery | 
| Quality of Laryngeal View Obtained With 2nd Laryngoscopy | The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible. | during laryngoscopy prior to intubation (few minutes prior to intubation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Taken for Intubation |  | throughout the intubation procedure | 
| POGO Score With 1st Laryngoscopy | POGO score is the percent of glottic opening observed during laryngoscopy. 100% POGO score indicates a full view of glottic opening and 0% POGO score indicates no glottic opening. | Before patient is intubated (few minutes before intubation) | 
| POGO Score With 2nd Laryngoscopy | POGO score is the percent of glottic opening observed during laryngoscopy. 100% POGO score indicates a full view of glottic opening and 0% POGO score indicates no glottic opening. | Before patient is intubated | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngoscopy [E04.580.373]