Airway ManagementNCT06176677
Use of a Low-cost Video Laryngoscope on Manikin
An observational study of Airway Management, run by Azienda USL Toscana Nord Ovest at 1 site in Italy.
Trial summary
Videolaryngoscopy has become essential in airway management, providing improved glottis visualization and reducing intubation attempts. Proficiency in using videolaryngoscopes, especially those with hyperangulated blades, is crucial for challenging intubation cases. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Management
- What is being tested?
- Videolaryngoscope and Boroscope
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2024to 2 Mar 2024
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 30 doctors and nurses in the emergency area and operating room
Inclusion Criteria: emergency and operating room personnel who have participated and completed the videolaryngoscopy course -
Exclusion Criteria: any temporary or permanent physical impediment to performing the requested maneuver or not having participated or completed the videolaryngoscopy course
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Training Effectiveness Between Commercial Videolaryngoscope and Low-Cost Self Built Laryngoscope With Hyperangulated Blade
Videolaryngoscopy has become essential in airway management, providing improved glottis visualization and reducing intubation attempts. Proficiency in using videolaryngoscopes, especially those with hyperangulated blades, is crucial for challenging intubation cases. However, successful intubation with hyperangulated blades requires continuous training due to their unique shape. Despite the benefits, the high cost of commercial videolaryngoscopes limits their use, prompting the exploration of a cost-effective alternative-a self-built laryngoscope using a USB borescope. The study aims to compare its training effectiveness with a commercial hyperangulated blade videolaryngoscope, emphasizing accessible training options. The evaluation involves testing both devices on a Laerdal® intubation mannequin, focusing on the time to glottis visualization and the time to complete intubation.
Read the detailed description
Videolaryngoscopy has become integral in airway management, providing improved visualization of the glottis and reducing the number of intubation attempts. Proficiency in the use of videolaryngoscopes is essential, particularly in cases of difficult intubation. Videolaryngoscopes equipped with hyperangulated blades facilitate enhanced visualization, even in the most challenging scenarios. However, successful intubation using these blades requires adequate training due to their unique shape. While hyperangulated blades offer excellent views around the curvature of the tongue, their upward perspective from the base of the tongue can pose challenges in tube delivery. Therefore, continuous training is essential to achieve proficiency with these particular blades.
Despite the advantages, the high cost of commercially available videolaryngoscopes poses a barrier to regular use and training, especially in resource-limited settings. This study introduces a cost-effective alternative-a self-built laryngoscope using a Universal Serial Bus (USB) borescope. The objective is to compare its training effectiveness with that of a commercial hyperangulated blade videolaryngoscope, underscoring the significance of accessible training options.
The Glidescope videolaryngoscope and a custom-built laryngoscope equipped with a USB borescope blade will undergo testing. The evaluation will be conducted by 30 emergency and operating room personnel following a brief training course in videolaryngoscopy, using a Laerdal® intubation mannequin. Both devices will utilize size 4 hyperangulated blades with identical curvature angles. Assessment endpoints will encompass the duration required for glottis visualization and the time needed for the entire intubation process.
- Conditions
- Airway Management
- Being tested
- Videolaryngoscope, Boroscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideolaryngoscopeDevice
We set as endpoint the time from insertion of each laryngoscope through the mouth to complete visualization of the glottis (T1) and the time to complete intubation manoeuvre(T2)
BoroscopeDevice
We set as endpoint the time from insertion of each laryngoscope through the mouth to complete visualization of the glottis (T1) and the time to complete intubation manoeuvre(T2)
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the effectiveness of training between a commercial videolaryngoscope and a low cost videolaryngoscope
Compare the training effectiveness between a commercial videolaryngoscope and a low-cost videolaryngoscope by measuring the time from the insertion of each laryngoscope through the mouth to the complete visualization of the glottis (T1) and the time taken for the entire intubation maneuver (T2) in the manikin, among 30 emergency and operating room operators .
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start15 Feb 2024
- Primary completion1 Mar 2024
- Study completion2 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Toscana Nord Ovest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Tani, Azienda USL Toscana Nord Ovest
- Investigators
- Alessandro Tani, MD, Principal investigator, area Vasta Toscana Nordovest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176677
- Sponsor's protocol ID
- AVNO2024-1
- Status last verified
- Mar 2024
- First submitted
- 11 Dec 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tani A, Vagheggini G, Tudisco S, Del Colombo V, Mannelli E, Lehle J. Use of low-cost modified laryngoscope for training in videolaryngoscopy. A comparison between a Macintosh modified laryngoscope and Stortz C MAC 8403XDK: a manikin study. Minerva Anestesiol. 2022 Jan-Feb;88(1-2):85-86. doi: 10.23736/S0375-9393.21.15998-X. Epub 2021 Sep 16. No abstract available.
PubMed 34527409
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Training Effectiveness Between Commercial Videolaryngoscope and Low-Cost Self Built Laryngoscope With Hyperangulated Blade
- ClinicalTrials.gov ID
- NCT06176677
- Acronym / sponsor ID
- AVNO2024-1
- Conditions
- Airway Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Azienda USL Toscana Nord OvestUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 2 Mar 2024 (actual)
- First posted
- 20 Dec 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.
Videolaryngoscopy has become essential in airway management, providing improved glottis visualization and reducing intubation attempts. Proficiency in using videolaryngoscopes, especially those with hyperangulated blades, is crucial for challenging intubation cases. However, successful intubation with hyperangulated blades requires continuous training due to their unique shape. Despite the benefits, the high cost of commercial videolaryngoscopes limits their use, prompting the exploration of a cost-effective alternative-a self-built laryngoscope using a USB borescope. The study aims to compare its training effectiveness with a commercial hyperangulated blade videolaryngoscope, emphasizing accessible training options. The evaluation involves testing both devices on a Laerdal® intubation mannequin, focusing on the time to glottis visualization and the time to complete intubation.
Detailed description
Videolaryngoscopy has become integral in airway management, providing improved visualization of the glottis and reducing the number of intubation attempts. Proficiency in the use of videolaryngoscopes is essential, particularly in cases of difficult intubation. Videolaryngoscopes equipped with hyperangulated blades facilitate enhanced visualization, even in the most challenging scenarios. However, successful intubation using these blades requires adequate training due to their unique shape. While hyperangulated blades offer excellent views around the curvature of the tongue, their upward perspective from the base of the tongue can pose challenges in tube delivery. Therefore, continuous training is essential to achieve proficiency with these particular blades.
Despite the advantages, the high cost of commercially available videolaryngoscopes poses a barrier to regular use and training, especially in resource-limited settings. This study introduces a cost-effective alternative-a self-built laryngoscope using a Universal Serial Bus (USB) borescope. The objective is to compare its training effectiveness with that of a commercial hyperangulated blade videolaryngoscope, underscoring the significance of accessible training options.
The Glidescope videolaryngoscope and a custom-built laryngoscope equipped with a USB borescope blade will undergo testing. The evaluation will be conducted by 30 emergency and operating room personnel following a brief training course in videolaryngoscopy, using a Laerdal® intubation mannequin. Both devices will utilize size 4 hyperangulated blades with identical curvature angles. Assessment endpoints will encompass the duration required for glottis visualization and the time needed for the entire intubation process.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30 doctors and nurses in the emergency area and operating room
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 |
|---|---|---|
| VideolaryngoscopeWe set as endpoint the time from insertion of each laryngoscope through the mouth to complete visualization of the glottis (T1) and the time to complete intubation manoeuvre(T2) | Device | – |
| BoroscopeWe set as endpoint the time from insertion of each laryngoscope through the mouth to complete visualization of the glottis (T1) and the time to complete intubation manoeuvre(T2) | Device | – |
Primary outcome
compare the effectiveness of training between a commercial videolaryngoscope and a low cost videolaryngoscope
Time frame: one hour
Compare the training effectiveness between a commercial videolaryngoscope and a low-cost videolaryngoscope by measuring the time from the insertion of each laryngoscope through the mouth to the complete visualization of the glottis (T1) and the time taken for the entire intubation maneuver (T2) in the manikin, among 30 emergency and operating room operators .
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 5 Mar 2024.
- Background: PubMed 34527409Tani A, Vagheggini G, Tudisco S, Del Colombo V, Mannelli E, Lehle J. Use of low-cost modified laryngoscope for training in videolaryngoscopy. A comparison between a Macintosh modified laryngoscope and Stortz C MAC 8403XDK: a manikin study. Minerva Anestesiol. 2022 Jan-Feb;88(1-2):85-86. doi: 10.23736/S0375-9393.21.15998-X. Epub 2021 Sep 16. No abstract available.
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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.
Alessandro Tani, MD principal investigator
area Vasta Toscana Nordovest
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, run by Azienda USL Toscana Nord Ovest at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 Mar 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 Italy. 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?
compare the effectiveness of training between a commercial videolaryngoscope and a low cost videolaryngoscope (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06176677, which also lists 1 linked publication.
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 5 Mar 2024.