Inselspital
Bern, Canton of Bern, 3010, Switzerland
NCT Number: NCT06397261
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.
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Notify Me18 year and older
All sexes
Observational
Bern, Canton of Bern, 3010, Switzerland
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Artificial Intelligence assisted tracheal video intubation
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
Time frame: 5 minutes
Overall success rate under assistance with larynGuide™
Time frame: 10 minutes
First-attempt oro-tracheal intubation success rate confirmed with waveform capnography in percentage
Time frame: 5 minutes
number of attempts until correct intubation
Time frame: 10 minutes
Number of the occurrence of any technical problem of the larynGuide™, a software for artificial intelligence assisted tracheal intubation (aiEndoscopic, Zürich, Switzerland)
Time frame: 2 minutes
Best percentage of glottic opening (POGO)
Time frame: 2 minutes
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.
Time frame: 5 minutes
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
Insel Gruppe AG, University Hospital Bern
Other
Artificial Intelligence Assisted Tracheal Video Intubation: an Observational Trial About Correctness of LarynGuide™
Acronym: LarynGuide
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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