Stylet Shape in Simulated Endotracheal Intubation by Medical Students

Randomised Controlled Trial of Stylet Shape in Simulated Endotracheal Intubation by Medical Students

Endotracheal intubation is a life saving procedure where a tube is placed into a person's windpipe to help them to breathe. This is a study of which shape of tube would lead to improved success in this procedure.

Study Overview

• Status: Recruiting
• Conditions: Endotracheal Intubation; Medical Education
• Intervention / Treatment: Procedure: Endotracheal intubation using an endotracheal tube with a 30 degree straight to cuff shape; Procedure: Endotracheal intubation using an endotracheal tube with an arcuate cuff shape

Detailed Description

Endotracheal intubation (ETI) is a lifesaving procedure. It involves placing a tube in the patient's airway to maintain ventilation and oxygenation.

Simulation has been shown to be effective for medical procedural skills training. Medical simulation literature now focuses on instructional design (ID) features that improve learning.

There are multiple aspects of ETI technique and ID that can be modified to improve successful ETI. Patient positioning, mastery learning, and dyad rather than solo practice are examples for which evidence exists to guide instructors. Despite this, ETI complication rates are substantial.

Thus, areas for continued improvement in ETI ID should be explored. One area is the optimal endotracheal tube (ETT) shape, achieved using a stylet, for novices learning ETI, for which there is limited evidence.

The straight to cuff (STC) shape has been postulated to optimise views of the airway compared to an arcuate shape. These shapes have only been directly compared as subgroups among multiple other comparisons in ETI technique in difficult intubations in one study. This does not generalise well to educating novices such as medical students, where intubations at normal difficulty are within the learner's zone of proximal development, and findings from subgroup comparisons are hypothesis generating rather than definitive evidence

This study will compare which shape is most likely to lead to successful endotracheal intubation, when performed by novices (medical students) learning this procedure on mannequins.

• Study Type: Interventional
• Enrollment (Estimated): 268
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew JW Low, MBBS; Phone Number: 6908 2222; Email: mlow@nus.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • Yong Loo Lin School of Medicine, National University of Singapore
    • Contact: Matthew JW Low, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Final year medical students in the Yong Loo Lin School of Medicine, National University of Singapore, undergoing their simulation posting. Endotracheal intubation is a procedure that is taught during this posting.

Exclusion Criteria:

• Injuries precluding performance of endotracheal intubation. Non exhaustive examples include arm injuries.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 30-degree straight to cuff; The endotracheal tube to be used for endotracheal intubation will have a stylet inserted into it and manipulated into a shape that is straight from its proximal end to the cuff. At the cuff, there will be a 30 degree anterior bend.	Procedure: Endotracheal intubation using an endotracheal tube with a 30 degree straight to cuff shape; Placement of an endotracheal tube into a simulated trachea in a mannequin using the abovementioned shape
Active Comparator: Arcuate; The endotracheal tube to be used for endotracheal intubation will have a stylet inserted into it and manipulated into an arcuate shape, and thus curved throughout the length of the tube.	Procedure: Endotracheal intubation using an endotracheal tube with an arcuate cuff shape; Placement of an endotracheal tube into a simulated trachea in a mannequin using the abovementioned shape

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to successful intubation	Defined as the time between insertion of the laryngoscope to successful placement of the tube in the trachea	Outcome assessment will occur within 2 weeks of endotracheal intubation being taught to participants, and immediately upon randomisation to a specified shape to attempt endotracheal intubation under video recording

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who successfully intubate on first pass of laryngoscope	Defined as successful placement of the tube into the trachea with only one insertion of the laryngoscope blade into the mouth	Outcome assessment will occur within 2 weeks of endotracheal intubation being taught to participants, and immediately upon randomisation to a specified shape to attempt endotracheal intubation under video recording
Proportion of participants who successfully intubate on first pass of endotracheal tube	Defined as successful placement of the tube into the trachea with only one insertion of the endotracheal tube into the mouth	Outcome assessment will occur within 2 weeks of endotracheal intubation being taught to participants, and immediately upon randomisation to a specified shape to attempt endotracheal intubation under video recording
Proportion of participants who perform an oesophageal intubation	Defined as placement of the endotracheal tube into the oesophagus as the end state of the participant's attempt	Outcome assessment will occur within 2 weeks of endotracheal intubation being taught to participants, and immediately after their intubation attempt under video recording

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore
• Collaborators: National University of Singapore
• Investigators: Principal Investigator: Matthew JW Low, MBBS, National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Medical education; Simulation
• Other Study ID Numbers: NUS-L2023-08-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan for this, as this was not a part of the approved IRB application

Drug and device information, study documents

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