Airway ManagementNCT05859542
Place of the Video-laryngoscope in Learning Intubation by Simulation
An observational study of Airway Management and Intubation, Intratracheal, run by Mongi Slim Hospital at 1 site in Tunisia.
Trial summary
The aim of the study was to determine the impact of the videolaryngoscope on reducing the time needed to intubate on a low-fidelity manikin for beginners. The investigators conducted a randomised crossover study, which took place in the simulation department of the medical school of Tunis. Read more about this study
- Who is it for?
- Ages 22 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Management, Intubation, Intratracheal, Simulation
- What is being tested?
- Videolaryngoscope first and Direct laryngoscope first
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jun 2023to 30 Jul 2023
- Phase
- Observational
- 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 22 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: We included 35 trainees. they were aged between 22 and 24 years old.
Who may be able to join
- fifth year's medical students.
- consentment of the participants
Who cannot join
- participants who had previously performed a tracheal intubation.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study was to determine the impact of the videolaryngoscope on reducing the time needed to intubate on a low-fidelity manikin for beginners.
The investigators conducted a randomised crossover study, which took place in the simulation department of the medical school of Tunis. They used a low-fidelity manikin designed for learning airway management. The first part of our session consisted in a theoretical training. The second part was the practical training with procedural simulation.
Read the detailed description
Simulation is nowadays a widespread teaching method, particularly in airway management. The direct laryngoscope is the most commonly used device for learning intubation. As for the videolaryngoscope, it is mostly used on an advanced level, for teaching difficult laryngoscopy to professionals. Its impact on teaching intubation to beginners remains unclear.
The aim of the study was to determine the impact of the videolaryngoscope on reducing the time needed to intubate on a low-fidelity manikin for beginners.
The investigators conducted a randomised crossover study, which took place in the simulation department of the medical school of Tunis. They used a low-fidelity manikin designed for learning airway management. They included 35 trainees.
The first part of our session consisted in a theoretical training, during which one single instructor exposed the anatomical basis and the material needed: a direct laryngoscope (Macintosh) with a number 3 curved blade, a videolaryngoscope (Med-Captain) with a number 3 curved blade and a number 7 tracheal tube with a stylet.
The second part was the practical training with procedural simulation. The investigators randomized the trainees in two groups.
Each trainee proceeded to three intubations with each device, in the specified order.
The investigators used the SPSS software for data analysis. The investigators considered a p-value < 0.05 as statistically significant.
- Conditions
- Airway Management, Intubation, Intratracheal, Simulation, Laryngoscopy
- Being tested
- Videolaryngoscope first, Direct laryngoscope first
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videolaryngoscope firstDevice
Also called VL
started the session with 3 intubations using the videolaryngoscope
Direct laryngoscope firstDevice
Also called DL
started the session with 3 intubations using the Direct laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Group A | The group A included 18 trainees, who started the session with videolaryngoscope followed by the direct laryngoscope. Receives: Device: Videolaryngoscope first | |
| Group B | The group B included 17 trainees, who started the session with the direct laryngoscope followed by the videolaryngoscope. Receives: Device: Direct laryngoscope first |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time needed for the first intubation.
Time en seconds needed for the tube to pass through the vocal cords.
Measured: up to 2 minutes
Secondary outcomes (2)
the Cormack-Lehane grade
Cormack and Lehane grades (1 to 4)
Measured: up to 2 minutes
the satisfaction of the trainees.
The score of satisfaction
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Jun 2023
- Primary completion27 Jun 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
- Investigators
- Mhamed Sami MS Mebazaa, Pr, Principal investigator, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859542
- Sponsor's protocol ID
- Sim intubation
- Status last verified
- Sep 2023
- First submitted
- 30 Apr 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Place of the Video-laryngoscope in Learning Intubation by Simulation
- ClinicalTrials.gov ID
- NCT05859542
- Acronym / sponsor ID
- Sim intubation
- Conditions
- Airway Management, Intubation, Intratracheal, Simulation, Laryngoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 16 May 2023 (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.
The aim of the study was to determine the impact of the videolaryngoscope on reducing the time needed to intubate on a low-fidelity manikin for beginners.
The investigators conducted a randomised crossover study, which took place in the simulation department of the medical school of Tunis. They used a low-fidelity manikin designed for learning airway management. The first part of our session consisted in a theoretical training. The second part was the practical training with procedural simulation.
Detailed description
Simulation is nowadays a widespread teaching method, particularly in airway management. The direct laryngoscope is the most commonly used device for learning intubation. As for the videolaryngoscope, it is mostly used on an advanced level, for teaching difficult laryngoscopy to professionals. Its impact on teaching intubation to beginners remains unclear.
The aim of the study was to determine the impact of the videolaryngoscope on reducing the time needed to intubate on a low-fidelity manikin for beginners.
The investigators conducted a randomised crossover study, which took place in the simulation department of the medical school of Tunis. They used a low-fidelity manikin designed for learning airway management. They included 35 trainees.
The first part of our session consisted in a theoretical training, during which one single instructor exposed the anatomical basis and the material needed: a direct laryngoscope (Macintosh) with a number 3 curved blade, a videolaryngoscope (Med-Captain) with a number 3 curved blade and a number 7 tracheal tube with a stylet.
The second part was the practical training with procedural simulation. The investigators randomized the trainees in two groups.
Each trainee proceeded to three intubations with each device, in the specified order.
The investigators used the SPSS software for data analysis. The investigators considered a p-value < 0.05 as statistically significant.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: Videolaryngoscope firstThe group A included 18 trainees, who started the session with videolaryngoscope followed by the direct laryngoscope. |
| Group B | – | Device: Direct laryngoscope firstThe group B included 17 trainees, who started the session with the direct laryngoscope followed by the videolaryngoscope. |
Who may qualify
- Ages
- 22 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We included 35 trainees. they were aged between 22 and 24 years old.
Key inclusion criteria (2 listed)
- fifth year's medical students.
- consentment of the participants
Key exclusion criteria (1 listed)
- participants who had previously performed a tracheal intubation.
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 |
|---|---|---|
| Videolaryngoscope firstAlso: VLstarted the session with 3 intubations using the videolaryngoscope | Device | Group A |
| Direct laryngoscope firstAlso: DLstarted the session with 3 intubations using the Direct laryngoscope | Device | Group B |
Primary outcome
the time needed for the first intubation.
Time frame: up to 2 minutes
Time en seconds needed for the tube to pass through the vocal cords.
2 secondary outcomes
the Cormack-Lehane grade
Time frame: up to 2 minutes
the satisfaction of the trainees.
Time frame: up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
Mhamed Sami MS Mebazaa, Pr principal investigator
Mongi Slim Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Management and Intubation, Intratracheal, run by Mongi Slim Hospital at 1 site in Tunisia.
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 2 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: finished, as of the sponsor's last update on 26 Sep 2023. 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 Tunisia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time needed for the first intubation. (time frame: up to 2 minutes). 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 26 Sep 2023.