Endotracheal IntubationNCT06525662
Stylet Shape in Simulated Endotracheal Intubation by Medical Students
A study testing Endotracheal intubation using an endotracheal tube with a 30 degree straight to cuff shape and Endotracheal intubation using an endotracheal tube with an arcuate cuff shape in people with Endotracheal Intubation and Medical Education, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endotracheal Intubation, Medical Education
- What is being tested?
- Endotracheal intubation using an endotracheal tube with a 30 degree straight to cuff shape and Endotracheal intubation using an endotracheal tube with an arcuate cuff shape
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteSingapore
- Study dates
- 10 Jul 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Injuries precluding performance of endotracheal intubation. Non exhaustive examples include arm injuries.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Yong Loo Lin School of Medicine, National University of Singapore
Singapore
Matthew JW Low, MBBS
About this study
Official title: Randomised Controlled Trial of 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.
Read the 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.
- Conditions
- Endotracheal Intubation, Medical Education
- Being tested
- Endotracheal intubation using an endotracheal tube with a 30 degree straight to cuff shape, Endotracheal intubation using an endotracheal tube with an arcuate cuff shape
- Keywords
- Medical education, Simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal intubation using an endotracheal tube with a 30 degree straight to cuff shapeProcedure or surgery
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 shapeProcedure or surgery
Placement of an endotracheal tube into a simulated trachea in a mannequin using the abovementioned shape
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Endotracheal intubation using an endotracheal tube with a 30 degree straight to cuff shape |
| 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. Receives: Procedure: Endotracheal intubation using an endotracheal tube with an arcuate cuff shape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to successful intubation
Defined as the time between insertion of the laryngoscope to successful placement of the tube in the trachea
Measured: 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 (3)
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
Measured: 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 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
Measured: 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
Measured: Outcome assessment will occur within 2 weeks of endotracheal intubation being taught to participants, and immediately after their intubation attempt under video recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start10 Jul 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Matthew JW Low, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525662
- Sponsor's protocol ID
- NUS-L2023-08-01
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan for this, as this was not a part of the approved IRB application
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Stylet Shape in Simulated Endotracheal Intubation by Medical Students
- ClinicalTrials.gov ID
- NCT06525662
- Acronym / sponsor ID
- NUS-L2023-08-01
- Conditions
- Endotracheal Intubation, Medical Education
- Keywords
- Medical education, Simulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| 30-degree straight to cuff | Experimental | Procedure: Endotracheal intubation using an endotracheal tube with a 30 degree straight to cuff shapeThe 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. |
| Arcuate | Active comparator | Procedure: Endotracheal intubation using an endotracheal tube with an arcuate cuff shapeThe 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Injuries precluding performance of endotracheal intubation. Non exhaustive examples include arm injuries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endotracheal intubation using an endotracheal tube with a 30 degree straight to cuff shapePlacement of an endotracheal tube into a simulated trachea in a mannequin using the abovementioned shape | Procedure or surgery | 30-degree straight to cuff |
| Endotracheal intubation using an endotracheal tube with an arcuate cuff shapePlacement of an endotracheal tube into a simulated trachea in a mannequin using the abovementioned shape | Procedure or surgery | Arcuate |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No. No plan for this, as this was not a part of the approved IRB application
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew JW Low, MBBS principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal intubation using an endotracheal tube with a 30 degree straight to cuff shape and Endotracheal intubation using an endotracheal tube with an arcuate cuff shape in people with Endotracheal Intubation and Medical Education, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew JW Low, MBBS (6908 2222, mlow@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.