Pediatric Intubation

Study Overview
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Brief Summary
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The aim of the study was to compare time and success rates of TruView PCD video laryngoscope and Macintosh laryngoscope for the pediatric emergency intubation with three airway scenarios in a standardized manikin model.

Official Title
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Comparison of the TruView PCD Video Laryngoscope and Macintosh Laryngoscope for Pediatric Tracheal Intubation by Novice Paramedics: A Randomized Crossover Simulation Trial.

Conditions
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Intubation, Cardiac Arrest

Intervention / Treatment
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* Device: Macintosh Laryngoscope
* Device: TruView PCD Video laryngoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: give voluntary consent to participate in the study inexperienced in pediatric intubation paramedics Exclusion Criteria: not meet the above criteria participants who had performed intubation in pediatric humans prior the trial or had previously TruView experience

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scenario A<br>The control scenario, where neither chest compression nor cervical stabilization was applied during intubation. | Device: Macintosh Laryngoscope<br>* Direct-Laryngoscopy<br>Device: TruView PCD Video laryngoscope<br>* Video-Laryngoscopy<br>|
| Experimental: Scenario B<br>The chest compression scenario, where continuous chest compression was applied using chest compression system LUCAS-2 (Physio-Control, Redmond, WA, USA). Chest compression was provided at a rate of 100 min-1 to a depth of 5-6 cm during all intubation procedures. | Device: Macintosh Laryngoscope<br>* Direct-Laryngoscopy<br>Device: TruView PCD Video laryngoscope<br>* Video-Laryngoscopy<br>|
| Experimental: Scenario C<br>The chest compression with cervical stabilization scenario, where both chest compression using Lucas-2 and cervical stabilization were applied. A correctly fitting standard cervical immobilization collar (StifNeck Select, Laerdal, Stavanger, Norway) was applied to the manikin's neck to prevent movement of the cervical spine. | Device: Macintosh Laryngoscope<br>* Direct-Laryngoscopy<br>Device: TruView PCD Video laryngoscope<br>* Video-Laryngoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to intubation | the time to intubation, defined as the time from insertion of the laryngoscope blade between the teeth to the first manual ventilation of the mannequin's lungs | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of intubation | success of the intubation attempt (i.e. tracheal or oesophageal placement of the tube) with was recorded when the success of the ventilation attempt was seen by the manikin's ventilation indicators. | 1 day | 
| Cormack-Lehan scale | self reported Cormack-Lehan scale during intubation | 1 day | 
| Dental compression | dental compression, with was assessed using a visual scale grading the pressure applied on the upper teeth (n=none, mild=1, moderate=2, severe=3). | 1day | 
| Ease of intubation (VAS) | To access subjective opinion about the difficulty of the each intubation method, participants were asked to rate it on a visual analogue scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult). | 1 day |