Bougies as Aid for Endotracheal Intubation Via Video Laryngoscopy During Continuous Chest Compressions

Study Overview
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Brief Summary
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The goal of this clinical trials is to analyze the effects of using bougies as adjuncts on the performance of endotracheal intubation via video laryngoscopy during cardiopulmonary resuscitation in anesthesia residents. The main question it aims to answer is whether bougie use has a significant effect on first-attempt failure of endotracheal intubation via video laryngoscopy during continuous chest compressions. Participants will perform endotracheal intubation via video laryngoscopy by four methods in a randomized order in a simulated cardiopulmonary resuscitation scenario on a manikin. The four methods are endotracheal intubations assisted by a railroaded bougie, assisted by a preloaded bougie, assisted by a stylet, and with no assistance. Researchers will compare the first-attempt failure rate of the four methods to see if a railroaded bougie method has a significant different first-attempt failure from that of the other three methods.

Official Title
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Bougies as Aid for Endotracheal Intubation Via Video Laryngoscopy During Continuous Chest Compressions by Anesthesia Residents: a Randomized Crossover Simulation Trial

Conditions
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Endotracheal Intubation, Cardiopulmonary Resuscitation, Simulation

Intervention / Treatment
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* Device: Railroaded bougie
* Device: Preloaded bougie
* Device: Stylet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Residents who are enrolled in the three-year standardized residency training program in the Department of Anesthesiology, Peking Union Medical College Hospital in February, 2023. Exclusion Criteria: Residents who refuse to participate and residents who fail the pre-test.
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: Crossover Assignment
Interventional Model Description: Participants will perform endotracheal intubation by four methods in a randomized order. The four methods are endotracheal intubations assisted by a railroaded bougie, assisted by a preloaded bougie, assisted by a stylet, and with no assistance.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Railroaded bougie<br>An endotracheal tube is loaded onto a bougie posterior to the placement of the bougie into the trachea. | Device: Railroaded bougie<br>* Residents expose the glottis by a video laryngoscope and place the tip of bougie through the vocal cords. Then, an assistant loads an endotracheal tube on the free end of the bougie. Residents advance the endotracheal tube over the bougie and withdraw the bougie.<br>|
| Other: Preloaded bougie<br>An endotracheal tube is loaded onto a bougie prior to initiating laryngoscopy. | Device: Preloaded bougie<br>* Residents expose the glottis by a video laryngoscope and perform the endotracheal intubation using a bougie with a preloaded endotracheal tube while an assistant secures the free end of the bougie. Residents withdraw the bougie when the endotracheal tube reaches an appropriate depth.<br>|
| Active Comparator: Stylet<br>A stylet is placed within an endotracheal tube prior to initiating laryngoscopy. | Device: Stylet<br>* Residents expose the glottis by a video laryngoscope and perform the endotracheal intubation with the assistance of a stylet. An assistant withdraws the stylet when the tip of the endotracheal tube passes through the vocal cords. Then residents place the endotracheal tube to an appropriate depth.<br>|
| No Intervention: Naked endotracheal tube<br>Residents expose the glottis by a video laryngoscope and perform the endotracheal intubation without assistance of stylet or bougie. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure on the first attempt | An attempt is terminated and defined as a failure when a resident tries for one minute but is still unable to start ventilation, or when a resident feels unable to succeed and decides to give up, or when a resident withdraws a laryngoscope blade, a bougie, or a tube out of the month after the initial insertion. This outcome will be measured based on videos of endotracheal intubation procedures recorded by a camera placed on the right side of the manikin. | At the completion of the intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure on two attempts | If the first attempt of a method fails, the resident will be given a second opportunity of the same method. This outcome will be measured based on videos of endotracheal intubation procedures recorded by a camera placed on the right side of the manikin. | At the completion of the intubation | 
| Duration of the first attempt | The time elapsed between the insertion of a laryngoscope blade into the month and either the start of ventilation in a successful attempt or the termination of a failed attempt. This outcome will be measured based on videos of endotracheal intubation procedures recorded by a camera placed on the right side of the manikin. | At the completion of the intubation | 
| Overall intubation duration | Duration of the first attempt if it succeeds or the sum of the duration of both attempts if the first attempt fails. This outcome will be measured based on videos of endotracheal intubation procedures recorded by a camera placed on the right side of the manikin. | At the completion of the intubation | 
| Self-reported intubation difficulty | 0-10 ranking scale with 0 representing the easiest and 10 the most difficult rated by the residents. | At the completion of the intubation |