Effect of Using Endotracheal Tube Introducer for Intubation During Mechanical Chest Compressions in a Manikin

Study Overview
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Brief Summary
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The aim of this study was to compare the impact of using ETI with the Macintosh laryngoscope on first pass success rates of the final year students of medical school on a manikin during continuous chest compressions with mechanical compression device.

Detailed Description
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Fifty-two final year students of Kocaeli University Medical School will participate to the study. The participants will complete the one-hour training lecture on the use of the Macintosh laryngoscope (ML) and the endotracheal tube introducer (ETI) that will be instructed by an emergency medicine specialist. The information section will be followed by a chance of practice each endotracheal intubation method once by using the ML with and without the ETI on the manikin. Mechanical compression device will be used to perform chest compressions. The manikin will be placed on an ambulance stretcher in a supine position. Airway interventions will be performed in a sitting position on a seat that will be adjusted to the same height with the ambulance seat. The airway kit will be placed beside the head of the manikin. Each participant will perform 2 airway interventions. Participants will be allowed for maximum 2 attempts for each method. Each procedure will be recorded to the video camera. The participants will be aware of the video camera. Following the interventions each participant will be asked to grade the difficulty of the both methods on a 5-point Likert scale defined as 1: very easy, 2: easy, 3: moderate, 4: difficult and 5: very difficult. The participants will be asked for whether they have prior clinical experience or not with ML or/and ML with ETI use.

Official Title
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Effect of Using Endotracheal Tube Introducer for Intubation During Mechanical Chest Compressions in a Manikin: Randomized, Prospective, Crossover Study

Conditions
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Intubation, Intratracheal, Advanced Cardiac Life Support

Intervention / Treatment
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* Device: Endotracheal tube introducer
* Device: Macintosh laryngoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who want to participate the study Exclusion Criteria: Participants who do not want to participate the study
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
Interventional Model Description: Participants will be randomized to perform either Macintosh laryngoscope or Macintosh laryngoscope with endotracheal tube introducer first, using the envelope method. After completing these initial interventions, they will use the second method.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ML + ETI<br>Intubation with using endotracheal tube introducer with the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device. | Device: Endotracheal tube introducer<br>* Use of endotracheal tube introducer with the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device.<br>Device: Macintosh laryngoscope<br>* Use of the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device.<br>|
| Active Comparator: ML<br>Intubation with using the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device. | Device: Macintosh laryngoscope<br>* Use of the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First pass success | Comparison of the first pass success of the Macintosh laryngoscope and Macintosh laryngoscope with endotracheal tube introducer groups | 1 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to endotracheal intubation | The mean time to successful endotracheal intubation of Macintosh laryngoscope and Macintosh laryngoscope with endotracheal tube introducer groups | 1 minute | 
| Second endotracheal intubation attempt success rates | Second endotracheal intubation attempt success rates of Macintosh laryngoscope and Macintosh laryngoscope with endotracheal tube introducer groups | 1 minute | 
| Difficulty level of each method according to the Likert scale | Grading the difficulty of the Macintosh laryngoscope and Macintosh laryngoscope with endotracheal tube introducer on a 5-point Likert scale | 1 minute |