Pediatric Intubation During Resuscitation

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 four intubation devices in a cardiopulmonary scenario with and without chest compressions with a standardized pediatric manikin model.

Detailed Description
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Emergency airway management during resuscitation is a critical skill in emergency medicine. According to the European Resuscitation Council (ERC) guidelines for resuscitation 2010 , endotracheal intubation (ETI) is considered the gold standard during resuscitation.

Official Title
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A Comparison of Endotracheal Intubation Using the Shikani Optical Stylet or the Endoeye Flexible Intubation During Pediatric Resuscitation

Conditions
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Intubation, Resuscitation

Intervention / Treatment
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* Device: Shikani Optical Stylet
* Device: Endoeye Flexible Intubation (LF-V)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: give voluntary consent to participate in the study minimum 1 year of work experience in emergency medicine experienced emergency medical personnel (paramedics, nurses, physicians) Exclusion Criteria: not meet the above criteria wrist or low back diseases

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intubation without chest compressions<br>Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions. | Device: Shikani Optical Stylet<br>* Optical intubation<br>Device: Endoeye Flexible Intubation (LF-V)<br>* endoscopy intubation<br>|
| Experimental: Intubation with uninterrupted chest compressions<br>Endotracheal intubation of pediatric mannikin during resuscitation with uninterrupted chest compressions. In order to simulate the difficulties associated with intubation during uninterrupted chest compressions, CPR was performed by using LUCAS-2 (Physio-Control, Redmond, WA, U.S.). | Device: Shikani Optical Stylet<br>* Optical intubation<br>Device: Endoeye Flexible Intubation (LF-V)<br>* endoscopy intubation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to intubation | time from insertion of the blade to the first manual ventilation of the manikin´s lungs. If time of intubation is over than 60 seconds, attempt was recognized as failure. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of intubation | effectiveness of the first, second and third intubation attempts and overall effectiveness of intubation by participants using four intubation devices. If the examinee failed at all attempts, the case was excluded from the time calculations. | 1 month | 
| VAS score | participants were asked which method they would prefer in a real-life resuscitation. | 1 month |