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NCT Number: NCT06525662

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yong Loo Lin School of Medicine, National University of Singapore

Singapore

Location status: Recruiting

Location contact

Matthew JW Low, MBBS

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Time to successful intubation

    Time frame: 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 outcomes

  1. Proportion of participants who successfully intubate on first pass of laryngoscope

    Time frame: 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

  2. Proportion of participants who successfully intubate on first pass of endotracheal tube

    Time frame: 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

  3. Proportion of participants who perform an oesophageal intubation

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew JW Low, MBBS

CONTACT

[email protected]

6908 2222

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

  • National University of Singapore

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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