A.I. Supported Laryngoscopy and Endotracheal Intubation: a Manikin Study (aiTN)

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.

Study Overview

• Status: Completed
• Conditions: Intubation; Difficult or Failed
• Intervention / Treatment: Device: Video laryngoscopy; Device: Video larnygoscopy

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 Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8008
    • Schulthess Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

1. Volunteer medical professionals
2. Experienced: consultant anaesthetists, resident anaesthetists and certified nurse
3. Inexperienced: junior doctors (other than anaesthetists), clinical year medical students, nurses and paramedics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard before AI support	Device: Video laryngoscopy; Standard video laryngoscopy before video laryngoscopy with additional larynGuide overlay
Experimental: AI support before standard	Device: Video larnygoscopy; Video laryngoscopy with additional larynGuide overlay before standard video laryngoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of first-attempt tracheal intubation success	12 single attempts per participant	2 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to intubation	12 single attempts per participant	2 minutes
Rate of total intubation success	12 single attempts per participant	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	2 minutes
Percentage of dental damage incidence	12 single attempts per participant	2 minutes

Collaborators and Investigators

• Sponsor: Schulthess Klinik
• Investigators: Study Chair: Christoph K Hofer, MD, Schulthess Klinik

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): August 25, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: airway management; Tracheal intubation; C-MAC video laryngoscope; LarynGuide software
• Other Study ID Numbers: ANEST-0004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No