Software-assisted placement of the ventilation tube: an observational study on the accuracy of the software's indications regarding the position of the ventilation tube

Zusammenfassung der Studie

With this study, we aim to analyze the function of the new CE-certified medical device Larynguide TM (aiEndoscopic, Zurich, Switzerland). This device, with an installed AI software, is used for the placement of the ventilation tube and for assessing the correct position of the ventilation tube. A study on models with Larynguide TM showed that AI-assisted placement of the ventilation tube by less experienced personnel can be successfully performed in a similar time as by experienced anesthetists. The newly developed software Larynguide TM aims to increase safety during the placement of the ventilation tube. Patients requiring general anesthesia with a ventilation tube during surgery at the University Hospital of Bern will be asked for their consent. The study is designed as an observational study: for all consenting patients, Larynguide TM will be used for the placement of the ventilation tube, provided that no exclusion criteria are present. This medical device does not differ, apart from the installed software, from the video spatulas we routinely use for the placement of the ventilation tube. Thus, participation in the study does not pose any additional risks to the patients. The aim of our observational study is to evaluate whether Larynguide TM can better judge and recognize the incorrect placement of the ventilation tube in humans thanks to the software, compared to the anesthetists themselves using a conventional video spatula. The anesthetist will use Larynguide TM for the placement of the ventilation tube, while judging for themselves whether the position of the ventilation tube is correct or not. Simultaneously, the study team will note the assessment from Larynguide TM. The induction of anesthesia is not delayed by the conduct of the study.

(BASEC)

Untersuchte Intervention

We investigate the process of placing a ventilation tube. Patients undergoing surgery with general anesthesia must be artificially ventilated. A possible method of securing the airway is the insertion of a ventilation tube. This is inserted in the sleeping patient using a laryngoscope/video laryngoscope. A laryngoscope is a spatula used to visualize the larynx and vocal cords to introduce the ventilation tube into the airways under direct vision. A video laryngoscope has the additional function of displaying on a small screen (at the top of the spatula handle) a transmission from a camera located at the tip of the spatula, allowing the laryngoscopy to be observed not only by the person performing it but also by a supervisor. During the placement of the ventilation tube, there is a risk, despite visualizing the larynx, of mistakenly placing the ventilation tube in the esophagus. If an incorrect placement goes unnoticed, it can lead to death, as the patient cannot be ventilated. aiEndoscopic has developed a video laryngoscope with an installed AI software (Larynguide TM), which assesses during the placement of the ventilation tube whether the tube has been correctly placed. The software displays its assessment in real-time on the monitor of the video laryngoscope as "confirmation" or "warning". Thus, the rate of unnoticed placements of the ventilation tube in the esophagus should be able to be reduced.

(BASEC)

Untersuchte Krankheit(en)

We investigate the placement of the ventilation tube, which is necessary to artificially ventilate patients. The health condition in which such an intervention is necessary arises when there is an indication for general anesthesia or generally for artificial ventilation (e.g., comatose state). Our research project does not focus on any specific disease but on an intervention applied across various clinical pictures.

(BASEC)

Sponsor

Thomas Riva

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Bern

(BASEC)

Datum der Bewilligung durch die Ethikkommission

30.05.2024

(BASEC)

Ergebnisse der Studie