Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657417
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
AI Supported Laryngoscopy and Endotracheal Intubation a Manikin Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
AI Supported Laryngoscopy and Endotracheal Intubation a Manikin Study
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
aiTN
Brief 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 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 eg 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 intubation39s success highly depends on user experience and skills Literature reports unexpected difficult intubations ranging from 5 to 10 mostly corresponding to a CormackLehane grade 3 or 44-7 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 715 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 amp 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
Complication rates and upper airway trauma after direct laryngoscopy with a Macintosh type blade in patients with normal airway have been reported up to 715 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 amp 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None