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Stylet Shape in Simulated Endotracheal Intubation by Medical Students

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06525662
Enrollment
268
Registered
2024-07-29
Start date
2024-07-10
Completion date
2025-12-31
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotracheal Intubation, Medical Education

Keywords

Medical education, Simulation

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.

Interventions

PROCEDUREEndotracheal 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

PROCEDUREEndotracheal 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

Sponsors

National University of Singapore
CollaboratorOTHER
National University Hospital, Singapore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Caregiver)

Masking description

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.

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

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Time to successful intubationOutcome 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 recordingDefined as the time between insertion of the laryngoscope to successful placement of the tube in the trachea

Secondary

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

Countries

Singapore

Contacts

Primary ContactMatthew JW Low, MBBS
mlow@nus.edu.sg6908 2222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026