Stylet Shape in Simulated Endotracheal Intubation by Medical Students

NCT06525662 | Recruiting

• 1 other identifier: NUS-L2023-08-01
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

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.

Conditions

Endotracheal Intubation; Medical Education

Keywords

Medical education; Simulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

30-degree straight to cuff

EXPERIMENTAL

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

Arcuate

ACTIVE COMPARATOR

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

Interventions

Endotracheal intubation using an endotracheal tube with a 30 degree straight to cuff shape PROCEDURE

Placement of an endotracheal tube into a simulated trachea in a mannequin using the abovementioned shape

30-degree straight to cuff

Endotracheal intubation using an endotracheal tube with an arcuate cuff shape PROCEDURE

Placement of an endotracheal tube into a simulated trachea in a mannequin using the abovementioned shape

Arcuate

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator

Study Sites (1)

Yong Loo Lin School of Medicine, National University of Singapore

Singapore, Singapore

RECRUITING

Study Officials

• Matthew JW Low, MBBS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew JW Low, MBBS

CONTACT

6908 2222; mlow@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The instructors teaching students how to use the different stylet shapes will be masked regarding the study hypothesis and participant group allocation. It will be emphasised to instructors that each participant has an equal amount of time to learn to use both shapes.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Design: Randomised controlled trial with 2 parallel groups Population: Final year medical students in NUS Medicine learning endotracheal intubation (ETI) with direct laryngoscopy using a Macintosh blade via simulation. These students have limited exposure to ETI and are novices in this procedure. Intervention: 30-degree STC styleted endotracheal tube (ETT) Comparator: Arcuate styleted ETT

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 29, 2024
• Study Start: July 10, 2024
• Primary Completion: March 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)