Intubation; Difficult or FailedaiTNNCT06657417
A.I. Supported Laryngoscopy and Endotracheal Intubation: a Manikin Study
A study testing Video laryngoscopy and Video larnygoscopy in people with Intubation; Difficult or Failed, run by Schulthess Klinik at 1 site in Switzerland.
Trial summary
LarynGuide is a newly developed AI-supported software for video laryngoscopy that supports the user through correct placement of endotracheal tube by means of audio-visual signals and warning of incorrect or potentially dangerous handling. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed
- What is being tested?
- Video laryngoscopy and Video larnygoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2024to 30 Aug 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
- Volunteer medical professionals
- Experienced: consultant anaesthetists, resident anaesthetists and certified nurse
- Inexperienced: junior doctors (other than anaesthetists), clinical year medical students, nurses and paramedics
Trial locations and contacts
1 site in 1 country.
About this study
LarynGuide is a newly developed AI-supported software for video laryngoscopy that supports the user through correct placement of endotracheal tube by means of audio-visual signals and warning of incorrect or potentially dangerous handling. This prospective study assesses the performance of tracheal intubation using video laryngoscopy with larynGuide AI overlay as compared to standard video larnygoscopy an simulation setting.
Read the detailed description
Tracheal intubation is a core competence in anesthesia and emergency medicine. This complex medical procedure aims to preserve gas exchange in the lungs. Vital for that is a secured and patent airway as soon as spontaneous ventilation ceases under general anesthesia or in life-threatening conditions like (e.g, respiratory insufficiency or resuscitation). Failure in securing an airway can result in hypoxemia, leading to neurologic damage, cardiovascular complications, and death. Complex anatomic structures or abnormalities of the upper airway, as well as airway trauma, bear the risk of failed intubation and inability to ventilate the lungs, which furthermore may result in ventilation and oxygenation failure. Tracheal intubation\'s success highly depends on user experience and skills. Literature reports unexpected difficult intubations ranging from 5 to 10%, mostly corresponding to a Cormack/Lehane grade 3 or 4.4-7. Besides classic direct laryngoscopes and flexible optic endoscopes, video laryngoscopes with high-resolution video cameras placed at the tip of the devices facilitate tracheal intubation. Video laryngoscopy seems superior in normal and difficult intubation, as it improves the first-attempt success rate.
Complication rates and upper airway trauma after direct laryngoscopy with a Macintosh type blade in patients with normal airway have been reported up to 7%15. Video laryngoscopy reduces that relative high incidence Upper airway trauma is increased when physical force is used during laryngoscopy to improve limited view on the glottis16 or if more than two intubation attempts are needed. The newly developed larynGuide software is an artificially intelligent video laryngoscope monitoring system which provides information to the user on visible anatomy, next steps to advance the oro-tracheal intubation to completion, and to advise on un-safe or incorrect maneuvers \& interventions. As soon as the device places the scope into the trachea the provider slides the tracheal tube over the scope into the proper place of the trachea as usually done during flexible scope intubation.
Aimof this study is to determine the effects larynGuide has on tracheal intubation performance compared with standard of care video laryngoscopy.
- Conditions
- Intubation; Difficult or Failed
- Being tested
- Video laryngoscopy, Video larnygoscopy
- Keywords
- Tracheal intubation, airway management, C-MAC video laryngoscope, LarynGuide software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video laryngoscopyDevice
Standard video laryngoscopy before video laryngoscopy with additional larynGuide overlay
Video larnygoscopyDevice
Video laryngoscopy with additional larynGuide overlay before standard video laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Standard before AI support | Experimental | Not described Receives: Device: Video laryngoscopy |
| AI support before standard | Experimental | Not described Receives: Device: Video larnygoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of first-attempt tracheal intubation success
12 single attempts per participant
Measured: 2 minutes
Secondary outcomes (4)
Time to intubation
12 single attempts per participant
Measured: 2 minutes
Rate of total intubation success
12 single attempts per participant
Measured: 2 minutes
Global Rating Scale of Procedural Performance
instrument handling, flow and knowledge of procedure for each intubation on a grade scale from 1 to 5; 12 single time points per participant
Measured: 2 minutes
Percentage of dental damage incidence
12 single attempts per participant
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Mar 2024
- Primary completion25 Aug 2024
- Study completion30 Aug 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 Intubation; Difficult or FailedStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The trial is a randomized 2x2 crossover design. Each procedure will be performed by the same participant in sequence with at least 3 days between the first and second round of procedures. The procedures will be performed in sequence to which the participants were randomized (TC: First Test and then Control or CT: First Control and then Test). A sequence of 6 intubations will be performed in each sitting (in order, 3 easy and 3 difficult).
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph K Hofer, MD, Study chair, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657417
- Sponsor's protocol ID
- ANEST-0004
- Acronym
- aiTN
- Status last verified
- Oct 2024
- First submitted
- 3 Sep 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Comaniciu A, Schurter D, Kanapari A, Lorenzoni G, Lazaridou A, Ganter MT, Gregori D, Hofer CK. AI-assisted videolaryngoscopy improves intubation success: results from a randomized simulation trial. J Clin Monit Comput. 2026 Aug;40(4):905-915. doi: 10.1007/s10877-026-01431-1. Epub 2026 Mar 30.
PubMed 41910861
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A.I. Supported Laryngoscopy and Endotracheal Intubation: a Manikin Study
- ClinicalTrials.gov ID
- NCT06657417
- Acronym / sponsor ID
- aiTN / ANEST-0004
- Conditions
- Intubation; Difficult or Failed
- Keywords
- Tracheal intubation, airway management, C-MAC video laryngoscope, LarynGuide software
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 25 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 24 Oct 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.
LarynGuide is a newly developed AI-supported software for video laryngoscopy that supports the user through correct placement of endotracheal tube by means of audio-visual signals and warning of incorrect or potentially dangerous handling. This prospective study assesses the performance of tracheal intubation using video laryngoscopy with larynGuide AI overlay as compared to standard video larnygoscopy an simulation setting.
Detailed description
Tracheal intubation is a core competence in anesthesia and emergency medicine. This complex medical procedure aims to preserve gas exchange in the lungs. Vital for that is a secured and patent airway as soon as spontaneous ventilation ceases under general anesthesia or in life-threatening conditions like (e.g, respiratory insufficiency or resuscitation). Failure in securing an airway can result in hypoxemia, leading to neurologic damage, cardiovascular complications, and death. Complex anatomic structures or abnormalities of the upper airway, as well as airway trauma, bear the risk of failed intubation and inability to ventilate the lungs, which furthermore may result in ventilation and oxygenation failure. Tracheal intubation\'s success highly depends on user experience and skills. Literature reports unexpected difficult intubations ranging from 5 to 10%, mostly corresponding to a Cormack/Lehane grade 3 or 4.4-7. Besides classic direct laryngoscopes and flexible optic endoscopes, video laryngoscopes with high-resolution video cameras placed at the tip of the devices facilitate tracheal intubation. Video laryngoscopy seems superior in normal and difficult intubation, as it improves the first-attempt success rate.
Complication rates and upper airway trauma after direct laryngoscopy with a Macintosh type blade in patients with normal airway have been reported up to 7%15. Video laryngoscopy reduces that relative high incidence Upper airway trauma is increased when physical force is used during laryngoscopy to improve limited view on the glottis16 or if more than two intubation attempts are needed. The newly developed larynGuide software is an artificially intelligent video laryngoscope monitoring system which provides information to the user on visible anatomy, next steps to advance the oro-tracheal intubation to completion, and to advise on un-safe or incorrect maneuvers \& interventions. As soon as the device places the scope into the trachea the provider slides the tracheal tube over the scope into the proper place of the trachea as usually done during flexible scope intubation.
Aimof this study is to determine the effects larynGuide has on tracheal intubation performance compared with standard of care video laryngoscopy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The trial is a randomized 2x2 crossover design. Each procedure will be performed by the same participant in sequence with at least 3 days between the first and second round of procedures. The procedures will be performed in sequence to which the participants were randomized (TC: First Test and then Control or CT: First Control and then Test). A sequence of 6 intubations will be performed in each sitting (in order, 3 easy and 3 difficult).
| Arm | Type | Receives |
|---|---|---|
| Standard before AI support | Experimental | Device: Video laryngoscopy |
| AI support before standard | Experimental | Device: Video larnygoscopy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Video laryngoscopyStandard video laryngoscopy before video laryngoscopy with additional larynGuide overlay | Device | Standard before AI support |
| Video larnygoscopyVideo laryngoscopy with additional larynGuide overlay before standard video laryngoscopy | Device | AI support before standard |
Primary outcome
Rate of first-attempt tracheal intubation success
Time frame: 2 minutes
12 single attempts per participant
4 secondary outcomes
Time to intubation
Time frame: 2 minutes
Rate of total intubation success
Time frame: 2 minutes
Global Rating Scale of Procedural Performance
Time frame: 2 minutes
Percentage of dental damage incidence
Time frame: 2 minutes
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 24 Oct 2024.
- Derived from this study: PubMed 41910861Comaniciu A, Schurter D, Kanapari A, Lorenzoni G, Lazaridou A, Ganter MT, Gregori D, Hofer CK. AI-assisted videolaryngoscopy improves intubation success: results from a randomized simulation trial. J Clin Monit Comput. 2026 Aug;40(4):905-915. doi: 10.1007/s10877-026-01431-1. Epub 2026 Mar 30.
- Individual participant dataSharing planned: No
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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.
Christoph K Hofer, MD study chair
Schulthess Klinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video laryngoscopy and Video larnygoscopy in people with Intubation; Difficult or Failed, run by Schulthess Klinik at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 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 Switzerland. 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?
Rate of first-attempt tracheal intubation success (time frame: 2 minutes). 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 NCT06657417, 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 24 Oct 2024.