IntubationLarynGuideNCT06397261
LarynGuide™ Assisted Tracheal Intubation
An observational study of Intubation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
This study aims to asses if the application of the larynGuide™, an assistive software running on a video-laryngoscope platform guiding laryngoscopy and intubation advise correctly and reliably on the position of the tracheal tube after an intubation attempt. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation
- What is being tested?
- LarynGuide
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Jun 2024to 8 May 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: german speaking adult patients classified ASA I, II or III undergoing surgery (except intracranial surgery) in general anaesthesia with tracheal intubation without contraindication for intubation with C-mac or indication for impossible mask ventilation and high aspiration risk with given informend consent.
Who may be able to join
- male or female patients ≥18 years
- ASA class I to III
- undergoing elective surgery in general anesthesia with tracheal intubation
Who cannot join
- Contraindication for intubation with C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) with a Macintosh nr 3 or 4 blade
- Patients < 18 years
- No proper trained personnel for the device at the study site
- Expected impossible mask ventilation.
- High risk of aspiration (requiring rapid sequence induction intubation)
- Intracranial surgery
- Limited knowledge of German language or refusing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Artificial Intelligence Assisted Tracheal Video Intubation: an Observational Trial About Correctness of LarynGuide™
This study aims to asses if the application of the larynGuide™, an assistive software running on a video-laryngoscope platform guiding laryngoscopy and intubation advise correctly and reliably on the position of the tracheal tube after an intubation attempt.
Read the detailed description
Eligible patients will be prepared for intubation according to the local SOPs of the anesthesia departments with mandatory monitoring of SpO2, HR, NIBP, EtCO2.
For the anesthesia Patients will be pre-oxygenated before induction via face-mask with FiO2 = 1.0 and flow rates of 18L/min until etO2 reaches 90%. Induction of anesthesia and TI will be performed using a combination of sedative/hypnotic drugs, opioids and non-depolarizing muscle relaxant. The following medications will be mandatory as per protocol:
- Hypnotic agent (Propofol 1-4 mg/kg).
- Opioids (Fentanyl 1-3 mcg/kg, Remifentanyl 1-3 mcg/kg).
- Non-depolarizing muscle relaxant (Rocuronium 0.5-1 mg/kg). After induction of anesthesia and the administration of the muscle relaxant, bag-mask ventilation with FiO2 = 1.0 (flow rates of 18 Lmin-1) will be performed until apnea sets in. After induction all patients will be paralyzed to facilitate airway management. Neuromuscular blockade will be assessed by train-of-four monitoring. Thereafter oxygen administration, laryngoscopy and tracheal intubation are performed as usually.
Tracheal intubation performed with the aid of larynGuide™, an assistive software running on a video-laryngoscope platform guiding laryngoscopy and intubation (aiEndoscopic, Zürich, Switzerland). The larynGuide™ will be combined with the C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) with a Macintosh nr 3 or 4 blade by a board-certified anesthesiologist. The board-certified anesthesiologist performing the intubation communicates to the research staff when he completed the intubation attempt. The anaesthesiologist in charge (board certified) checks to assess the correctness of the tube position by visual check and by attaching the patient to the ventilator and measuring the endtidal CO2 (Gold standard for detection of tube placement in anesthesia).
For the study the research staff will then - after the confirmation of the anaesthesiologist in charge of the tubes correct placement - look if the software displays a green light or the words "Bad intubation" on the monitor and document either outcome.
- Conditions
- Intubation
- Being tested
- LarynGuide
- Keywords
- Artificial Intelligence, Tracheal video intubation, larynGuide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LarynGuideDevice
Artificial Intelligence assisted tracheal video intubation
| Study group | Role | What they receive |
|---|---|---|
| adult patients undergoing elective surgery | adult patients undergoing elective surgery requiring tracheal intubation Receives: Device: LarynGuide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of correct assessment given by larynGuide™
Correctness of the advice measured by accuracy of the LarynGuide™, a software for artificial intelligence assisted tracheal intubation (aiEndoscopic, Zürich, Switzerland) on tube position given at the end of an intubation attempt
Measured: 5 minutes
Secondary outcomes (7)
Overall success rate
Overall success rate under assistance with larynGuide™
Measured: 5 minutes
first-attempt success rate
First-attempt oro-tracheal intubation success rate confirmed with waveform capnography in percentage
Measured: 10 minutes
Number of attempts
number of attempts until correct intubation
Measured: 5 minutes
Number of incidents of technical problems of larynGuide™
Number of the occurrence of any technical problem of the larynGuide™, a software for artificial intelligence assisted tracheal intubation (aiEndoscopic, Zürich, Switzerland)
Measured: 10 minutes
Percentage of glottic opening
Best percentage of glottic opening (POGO)
Measured: 2 minutes
Rate of Cormack & Lehane Score from 1 to 4
Cormack-Lehane classification is used to describe laryngeal view during direct laryngoscopy and can be divided into 4 grades of which 1 is the best (all of the glottis can be seen - so the best view) and 4 is the worste (not even the epiglottis is visible - worst view) the occurrence of which we will be counting.
Measured: 2 minutes
Occurrence rate of airway management complications
Complications during and after airway management such oral/airway injury with bleeding, difficult bag-mask ventilation, emesis, aspiration of gastric contents, hypotension necessitating treatment, hypoxia causing bradycardia requiring chest compressions, pneumothorax and the administration of resuscitation drugs
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start3 Jun 2024
- Primary completion30 Mar 2025
- Study completion8 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- aiEndsoscopic
- Responsible party
- Principal investigator, Thomas Riva, Insel Gruppe AG, University Hospital Bern
- Investigators
- Thomas Riva, Prof., Principal investigator, Bern Univerisity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397261
- Sponsor's protocol ID
- LarynGuide
- Acronym
- LarynGuide
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Assisted Tracheal Video Intubation: an Observational Trial About Correctness of LarynGuide™
- ClinicalTrials.gov ID
- NCT06397261
- Acronym / sponsor ID
- LarynGuide / LarynGuide
- Conditions
- Intubation
- Keywords
- Artificial Intelligence, Tracheal video intubation, larynGuide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- aiEndsoscopic
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 8 May 2025 (actual)
- First posted
- 2 May 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.
This study aims to asses if the application of the larynGuide™, an assistive software running on a video-laryngoscope platform guiding laryngoscopy and intubation advise correctly and reliably on the position of the tracheal tube after an intubation attempt.
Detailed description
Eligible patients will be prepared for intubation according to the local SOPs of the anesthesia departments with mandatory monitoring of SpO2, HR, NIBP, EtCO2.
For the anesthesia Patients will be pre-oxygenated before induction via face-mask with FiO2 = 1.0 and flow rates of 18L/min until etO2 reaches 90%. Induction of anesthesia and TI will be performed using a combination of sedative/hypnotic drugs, opioids and non-depolarizing muscle relaxant. The following medications will be mandatory as per protocol:
- Hypnotic agent (Propofol 1-4 mg/kg).
- Opioids (Fentanyl 1-3 mcg/kg, Remifentanyl 1-3 mcg/kg).
- Non-depolarizing muscle relaxant (Rocuronium 0.5-1 mg/kg). After induction of anesthesia and the administration of the muscle relaxant, bag-mask ventilation with FiO2 = 1.0 (flow rates of 18 Lmin-1) will be performed until apnea sets in. After induction all patients will be paralyzed to facilitate airway management. Neuromuscular blockade will be assessed by train-of-four monitoring. Thereafter oxygen administration, laryngoscopy and tracheal intubation are performed as usually.
Tracheal intubation performed with the aid of larynGuide™, an assistive software running on a video-laryngoscope platform guiding laryngoscopy and intubation (aiEndoscopic, Zürich, Switzerland). The larynGuide™ will be combined with the C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) with a Macintosh nr 3 or 4 blade by a board-certified anesthesiologist. The board-certified anesthesiologist performing the intubation communicates to the research staff when he completed the intubation attempt. The anaesthesiologist in charge (board certified) checks to assess the correctness of the tube position by visual check and by attaching the patient to the ventilator and measuring the endtidal CO2 (Gold standard for detection of tube placement in anesthesia).
For the study the research staff will then - after the confirmation of the anaesthesiologist in charge of the tubes correct placement - look if the software displays a green light or the words "Bad intubation" on the monitor and document either outcome.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients undergoing elective surgery | – | Device: LarynGuideadult patients undergoing elective surgery requiring tracheal intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- german speaking adult patients classified ASA I, II or III undergoing surgery (except intracranial surgery) in general anaesthesia with tracheal intubation without contraindication for intubation with C-mac or indication for impossible mask ventilation and high aspiration risk with given informend consent.
Key inclusion criteria (3 listed)
- male or female patients ≥18 years
- ASA class I to III
- undergoing elective surgery in general anesthesia with tracheal intubation
Key exclusion criteria (7 listed)
- Contraindication for intubation with C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) with a Macintosh nr 3 or 4 blade
- Patients < 18 years
- No proper trained personnel for the device at the study site
- Expected impossible mask ventilation.
- High risk of aspiration (requiring rapid sequence induction 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 |
|---|---|---|
| LarynGuideArtificial Intelligence assisted tracheal video intubation | Device | adult patients undergoing elective surgery |
Primary outcome
Rate of correct assessment given by larynGuide™
Time frame: 5 minutes
Correctness of the advice measured by accuracy of the LarynGuide™, a software for artificial intelligence assisted tracheal intubation (aiEndoscopic, Zürich, Switzerland) on tube position given at the end of an intubation attempt
7 secondary outcomes
Overall success rate
Time frame: 5 minutes
first-attempt success rate
Time frame: 10 minutes
Number of attempts
Time frame: 5 minutes
Number of incidents of technical problems of larynGuide™
Time frame: 10 minutes
Percentage of glottic opening
Time frame: 2 minutes
Rate of Cormack & Lehane Score from 1 to 4
Time frame: 2 minutes
Occurrence rate of airway management complications
Time frame: 5 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 14 May 2025.
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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.
Thomas Riva, Prof. principal investigator
Bern Univerisity 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 Intubation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 inclusion and 7 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 14 May 2025. 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 correct assessment given by larynGuide™ (time frame: 5 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 14 May 2025.