Stylet Shape in Simulated Endotracheal Intubation by Medical Students

NCT ID: NCT06525662

Last Updated: 2024-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-10

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Endotracheal Intubation Medical Education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Caregivers
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.

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Endotracheal intubation using an endotracheal tube with an arcuate cuff shape

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National University of Singapore

OTHER

Sponsor Role collaborator

National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew JW Low, MBBS

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

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Yong Loo Lin School of Medicine, National University of Singapore

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Matthew JW Low, MBBS

Role: CONTACT

6908 2222

Facility Contacts

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Matthew JW Low, MBBS

Role: primary

Other Identifiers

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NUS-L2023-08-01

Identifier Type: -

Identifier Source: org_study_id

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