Comparison of iLTS and LMA Fastrach in a Simulated Airway.

Study Overview
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Brief Summary
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Comparison of time to ventilation based on the chest rising of the Airway Simulator between the iLTS-D and LMA Fastrach

Detailed Description
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Prior to the study every participant obtained a standardized instruction of each device. In the proposed clinical trial the primary study objective will be to determine whether there is a difference in time to ventilation via endotracheal tube (seconds) for the novel iLTS-D compared to the LMA Fastrach. Time to Ventilation will be defined from when the tip of the extraglottic airway device passed the incisors to the point until confirmation the first chest rise of the high fidelity simulator (Laerdal SimMan). Additionally, two time points before final tracheal placement will evaluated: time to place the EGA and time to ventilate with the EGA after introducing the device into the oral cavity.

Official Title
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Comparison of the Novel iLTS and Fastrach Intubation Laryngeal Mask for Time to Ventilation in a Simulated Airway.

Conditions
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Ventilation Therapy; Complications

Intervention / Treatment
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* Device: Time to ventilation with the iLTS
* Device: Time to ventilation with the Fastrach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical students Present written informed consent of the research participant Exclusion Criteria: • inability to consent
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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Time to ventilation with the iLTS<br>Measuring the time to ventilation (ET) based of insert the iLTS until the chest rise of the simulator in seconds | Device: Time to ventilation with the iLTS<br>* Time to ventilation (ET) based of insert the iLTS until the chest rise of the simulator in seconds<br>Device: Time to ventilation with the Fastrach<br>* Time to ventilation (ET) based of insert the Fastrach until the chest rise of the simulator in seconds<br>|
| Experimental: Time to ventilation with the Fastrach<br>Measuring time to ventilation (ET) based of insert the Fastrach until the chest rise of the simulator in seconds | Device: Time to ventilation with the iLTS<br>* Time to ventilation (ET) based of insert the iLTS until the chest rise of the simulator in seconds<br>Device: Time to ventilation with the Fastrach<br>* Time to ventilation (ET) based of insert the Fastrach until the chest rise of the simulator in seconds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to ventilation via endotracheal tube | time to ventilation will defined from when the Endotracheal tube insert into the extraglottic airway device until the first chest rise | 0 to 300 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to ventilation via extraglottic airway device | time to ventilation will defined from when the device tip passed the incisors to the point until the first chest rise | 0 to 300 seconds | 
| Intubation attempts | Numbers of successful intubation attempts (1-5 attempts) | 0 to 300 seconds | 
| Ease of Insertion | Subjective Grading of the insertion process (Lickert Scale from 1 very easy to 5 very difficult) | 0 to 420 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway, extraglottic, simulation, laryngeal mask