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

Endotracheal Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05689125
• Other study ID #: K2562
• Status: Completed
• Phase: N/A
• Start date: February 9, 2023
• Est. completion date: February 20, 2023

Study information

• Verified date: June 2023
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 20, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiopulmonary Resuscitation
• Endotracheal Intubation
• Simulation

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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