Comparison Four Intubation Devices

Study Overview
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Brief Summary
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Comparison of four laryngoscope blades (Miller, Macintosh, Phillips and Wis-Hipple) for infant intubation during resuscitation with and without chest compressions.

Official Title
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Comparison of Tracheal Intubation Using the Miller, Macintosh, Phillips and Wis-Hipple Blades During Infant Resuscitation: A Randomized Crossover Simulation Trial

Conditions
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Intubation

Intervention / Treatment
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* Device: MIL
* Device: MAC
* Device: WIS
* Device: PHIL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: give voluntary consent to participate in the study paramedics no clinical experience in infant intubation Exclusion Criteria: not meet the above criteria wrist or low back diseases pregnancy.

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: Intubation without chest compression<br>Endotracheal intubation of infant mannikin using different laryngoscope blades (MAC, MIL, PHIL, WIS) during resuscitation without chest compressions. | Device: MIL<br>* Direct laryngoscopy 1<br>* Other names: Miller blade;Device: MAC<br>* Direct laryngoscopy 2<br>* Other names: Macintosh blade;Device: WIS<br>* Direct laryngoscopy 3<br>* Other names: Wis-Hipple blade;Device: PHIL<br>* Direct laryngoscopy 4<br>* Other names: Phillips blade;|
| Experimental: Intubation with chest compression<br>Endotracheal intubation of infant mannikin using different laryngoscope blades (MAC, MIL, PHIL, WIS) with uninterrupted chest compressions. Chest compressions with the two thumb-encircling hands technique were performed by the same Basic Life Support (BLS) instructor at a rate of 100 compressions per minute and at a depth of about 1.5 inches according to the European Resuscitation Council guidelines of 2010 year. | Device: MIL<br>* Direct laryngoscopy 1<br>* Other names: Miller blade;Device: MAC<br>* Direct laryngoscopy 2<br>* Other names: Macintosh blade;Device: WIS<br>* Direct laryngoscopy 3<br>* Other names: Wis-Hipple blade;Device: PHIL<br>* Direct laryngoscopy 4<br>* Other names: Phillips blade;|

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 day | 

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 day | 
| Ease of Use | To access subjective opinions about the difficulty of the each intubation method, participants were asked to give a rating on a visual analogue scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult). | 1 day | 
| POGO score | The POGO score describes how much glottic opening is visible. A POGO score of 100% indicates visualization of the entire glottic opening from the anterior commissure of the vocal cords to the interarytenoid notch. A POGO score of 0% corresponds with no visualization of laryngeal structures. | 1 day | 
| Cormack-Lehane grading | self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4) | 1 day | 
| dental compression | pressure applied on the upper teeth (n=none, mild=1, moderate=2, severe=3) | 1 day |