Clinical trial NCT06525662: Stylet Shape in Simulated Endotracheal Intubation by Medical Students
Official title: Randomised Controlled Trial of Stylet Shape in Simulated Endotracheal Intubation by Medical Students
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endotracheal Intubation
Medical Education
Keywords: Medical education
Simulation
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: National University of Singapore
First posted: 2024-07-29
Enrollment: 268
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to successful intubation
timeFrame: 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:
measure: Proportion of participants who successfully intubate on first pass of laryngoscope
timeFrame: 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
measure: Proportion of participants who successfully intubate on first pass of endotracheal tube
timeFrame: 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
measure: Proportion of participants who perform an oesophageal intubation
timeFrame: Outcome assessment will occur within 2 weeks of endotracheal intubation being taught to participants, and immediately after their intubation attempt under video recording
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Yong Loo Lin School of Medicine, National University of Singapore
Study officials:
affiliation: National University Hospital, Singapore
name: Matthew JW Low, MBBS
role: PRINCIPAL_INVESTIGATOR
References: