Stylet Shape in Simulated Endotracheal Intubation by Medical Students

Not Applicable

Recruiting

• Conditions: Medical Education; Endotracheal Intubation
• Interventions: 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

• Registration Number: NCT06525662
• Lead Sponsor: National University Hospital, Singapore

Brief Summary

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.

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 Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-08
• Study Start: 2024-07-10
• Study First Submitted QC: 2024-07-24
• Last Update Submitted: 2024-07-24
• Study First Posted: 2024-07-29
• Last Update Posted: 2024-07-29
• Primary Completion: 2025-03-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 268

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30-degree straight to cuff	Endotracheal intubation using an endotracheal tube with a 30 degree straight to cuff shape	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.
Arcuate	Endotracheal intubation using an endotracheal tube with an arcuate cuff shape	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.

Primary Outcome Measures

Name	Time	Method
Time to successful intubation	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	Defined as the time between insertion of the laryngoscope to successful placement of the tube in the trachea

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yong Loo Lin School of Medicine, National University of Singapore; 🇸🇬 Singapore, Singapore