An observational study in Intubation, sponsored by Insel Gruppe AG, University Hospital Bern. Not yet recruiting at 1 site in Switzerland. Open to participants aged 6 Months to 6 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Insel Gruppe AG, University Hospital Bern · Observational
The aim of this study is to investigate whether the use of larynGuide™ provides accurate and reliable information regarding the position of the endotracheal tube following an intubation attempt in children. larynGuide™ is a software tool that runs on a video laryngoscope platform to assist with laryngoscopy and intubation.
Eligible patients will be prepared for intubation according to the local Standard Operating Procedures (SOPs) of the anaesthesia departments. Mandatory monitoring: saturation of peripheral oxygen (SpO₂), heart rate (HR), non-invasive blood pressure (NIBP), end-tidal carbon dioxide (EtCO₂).
The larynGuide™ software system (consisting of 2 displays, one regular C-MAC video laryngoscope monitor (KARL STORZ, Tuttlingen, Germany) which will be used by the board-certified anaesthesiologist for intubation and the other one for the study team displaying the software which is not to be seen from the anaesthetist perspective) is being taken to the induction room making sure that display is not to be seen from the anaesthesiologist point of view.
Induction of anaesthesia: If feasible, all children included in this protocol will be pre oxygenated before induction of anaesthesia for one minute through face-mask with Fraction of inspired oxygen (FiO₂) 1.0 and flow rates of 6-10L/min. The induction of anaesthesia for tracheal intubation 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:
Before intubation: After induction of anaesthesia and the administration of a NMBA, bag-mask ventilation with FiO₂ 1.0 (flow rates of 6-10 L/min) will be performed for 60 seconds until apnea sets in. Thereafter bag-mask ventilation will be stopped and apnoeic oxygenation (1l/kgBW) will be started. Video laryngoscopy will be performed with a C-MAC video laryngoscope and the patient's trachea will be intubated. Once the intubation attempt is completed, the software displays a green light for the correct tube position or the words "Bad intubation" on the monitor (which is only seen by the study personnel). The anaesthesiologist in charge (board certified) performs checks to assess the correctness of the tracheal tube position by visual check and by attaching the patient to the ventilator and measuring the endtidal carbon dioxide (CO₂) (Gold standard to rule out oesophageal intubation in anaesthesia). After the board-certified anaesthesiologist communicated to have completed the intubation attempt, the research staff will look if the software displays a green light or the words "Bad intubation" on the monitor.
Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pediatric patients aged 6 months to 6 years with German-speaking parents classified American Society of Anesthesiologists (ASA) I, II or III undergoing surgery (except intracranial surgery) in general anaesthesia with tracheal intubation without contraindication for intubation with C-MAC video laryngoscope (KARL STORZ, Tuttlingen, Germany) or indication for impossible mask ventilation and high aspiration risk with given informend consent
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pediatric patients (≥ 6 months to ≤ 6 years) undergoing elective surgery surgery in general anaesthesia with tracheal intubation
Device: LarynGuide
Artificial Intelligence assisted tracheal video intubation in children
Rate of correct assessment given by larynGuide™
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
Overall success rate under assistance with larynGuide™
Time frame: 5 minutes
first-attempt success rate
First-attempt oro-tracheal intubation success rate confirmed with waveform capnography in percentage
Time frame: 10 minutes
Number of attempts
number of attempts until correct intubation
Time frame: 5 minutes
Number of incidents of technical problems of larynGuide™
Number of the occurrence of any technical problem of the larynGuide™, a software for artificial intelligence assisted tracheal intubation (aiEndoscopic, Zürich, Switzerland)
Time frame: 10 minutes
Percentage of glottic opening (POGO)
Best percentage of glottic opening (POGO)
Time frame: 2 minutes
Rate of Cormack & Lehane Score from 1 to 4
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 these grades will be recorded.
Time frame: 2 minutes
Occurrence rate of airway management complications
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
Time frame: 5 minutes
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Insel Gruppe AG, University Hospital Bern →