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| Name | Class |
|---|---|
| National University of Singapore | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who successfully intubate on first pass of laryngoscope | Defined as successful placement of the tube into the trachea with only one insertion of the laryngoscope blade into the mouth | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew JW Low, MBBS | Contact | 6908 2222 | mlow@nus.edu.sg |
| Name | Affiliation | Role |
|---|---|---|
| Matthew JW Low, MBBS | National University Hospital, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yong Loo Lin School of Medicine, National University of Singapore | Recruiting | Singapore | Singapore |
No plan for this, as this was not a part of the approved IRB application
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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
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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.
| 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 |
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| Proportion of participants who successfully intubate on first pass of endotracheal tube | Defined as successful placement of the tube into the trachea with only one insertion of the endotracheal tube into the mouth | 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 | Defined as placement of the endotracheal tube into the oesophagus as the end state of the participant's attempt | Outcome assessment will occur within 2 weeks of endotracheal intubation being taught to participants, and immediately after their intubation attempt under video recording |