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

NCT05689125 | Completed DMC

• 1 other identifier: K2562
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endotracheal Intubation; Cardiopulmonary Resuscitation; Simulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Failure on two attempts

  At the completion of the intubation

• Duration of the first attempt

  At the completion of the intubation

• Overall intubation duration

  At the completion of the intubation

• Self-reported intubation difficulty

  At the completion of the intubation

Study Arms (4)

Railroaded bougie

EXPERIMENTAL

An endotracheal tube is loaded onto a bougie posterior to the placement of the bougie into the trachea.

Device: Railroaded bougie

Preloaded bougie

OTHER

An endotracheal tube is loaded onto a bougie prior to initiating laryngoscopy.

Device: Preloaded bougie

Stylet

ACTIVE COMPARATOR

A stylet is placed within an endotracheal tube prior to initiating laryngoscopy.

Device: Stylet

Naked endotracheal tube

NO INTERVENTION

Residents expose the glottis by a video laryngoscope and perform the endotracheal intubation without assistance of stylet or bougie.

Interventions

Railroaded bougie DEVICE

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.

Railroaded bougie

Preloaded bougie DEVICE

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.

Preloaded bougie

Stylet DEVICE

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.

Stylet

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Residents who refuse to participate and residents who fail the pre-test.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

• Xu X, Ma H, Zhang Y, Liu W, Jung B, Li X, Shen L. Efficacy of bougie first approach for endotracheal intubation with video laryngoscopy during continuous chest compression: a randomized crossover manikin trial. BMC Anesthesiol. 2024 May 21;24(1):181. doi: 10.1186/s12871-024-02560-3.

  PMID: 38773386 DERIVED

Study Officials

• Xu Li, MD

  Peking Union Medical College Hospital

  STUDY CHAIR

• Yuguang Huang, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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.

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 18, 2023
• Study Start: February 9, 2023
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)