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

S

Schulthess Klinik

Status

Completed

Conditions

Intubation; Difficult or Failed

Treatments

Device: Video laryngoscopy
Device: Video larnygoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT06657417
ANEST-0004

Details and patient eligibility

About

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.

Full 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.

Enrollment

74 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

  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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

74 participants in 2 patient groups

Standard before AI support
Experimental group
Treatment:
Device: Video laryngoscopy
AI support before standard
Experimental group
Treatment:
Device: Video larnygoscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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