LarynGuide™ Assisted Tracheal Intubation
LarynGuide
Artificial Intelligence Assisted Tracheal Video Intubation: an Observational Trial About Correctness of LarynGuide™
1 other identifier
observational
110
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2024
CompletedFirst Posted
Study publicly available on registry
May 2, 2024
CompletedStudy Start
First participant enrolled
June 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2025
CompletedMay 14, 2025
May 1, 2024
10 months
April 29, 2024
May 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
5 minutes
Secondary Outcomes (7)
Overall success rate
5 minutes
first-attempt success rate
10 minutes
Number of attempts
5 minutes
Number of incidents of technical problems of larynGuide™
10 minutes
Percentage of glottic opening
2 minutes
- +2 more secondary outcomes
Study Arms (1)
adult patients undergoing elective surgery
adult patients undergoing elective surgery requiring tracheal intubation
Interventions
Artificial Intelligence assisted tracheal video intubation
Eligibility Criteria
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.
You may qualify if:
- male or female patients ≥18 years
- ASA class I to III
- undergoing elective surgery in general anesthesia with tracheal intubation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Insel Gruppe AG, University Hospital Bernlead
- aiEndsoscopiccollaborator
Study Sites (1)
Inselspital
Bern, Canton of Bern, 3010, Switzerland
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Riva, Prof.
Bern Univerisity Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med. Thomas Riva
Study Record Dates
First Submitted
April 29, 2024
First Posted
May 2, 2024
Study Start
June 3, 2024
Primary Completion
March 30, 2025
Study Completion
May 8, 2025
Last Updated
May 14, 2025
Record last verified: 2024-05