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

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

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.

Study Overview

• Status: Completed
• Conditions: Endotracheal Intubation; Simulation; Cardiopulmonary Resuscitation
• Intervention / Treatment: Device: Railroaded bougie; Device: Preloaded bougie; Device: Stylet

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Railroaded bougie; An endotracheal tube is loaded onto a bougie posterior to the placement of the bougie into the trachea.	Device: Railroaded bougie; 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.
Other: Preloaded bougie; An endotracheal tube is loaded onto a bougie prior to initiating laryngoscopy.	Device: Preloaded bougie; 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.
Active Comparator: Stylet; A stylet is placed within an endotracheal tube prior to initiating laryngoscopy.	Device: Stylet; 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.
No Intervention: Naked endotracheal tube; Residents expose the glottis by a video laryngoscope and perform the endotracheal intubation without assistance of stylet or bougie.

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Chair: Xu Li, MD, Peking Union Medical College Hospital; Principal Investigator: YuGuang Huang, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2023
• Primary Completion (Actual): February 20, 2023
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 10, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: K2562

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study plan can be obtained from the principal investigator on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No