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Not yet recruitingNCT07922434DOLPHINUpdated Nov 6, 2026

AI-assisted Tracheal Intubation in Children

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

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
110
Ages
6 Months to 6 Years
Sex
All
01

Study summary

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.

Read the detailed description

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:

  • One or more of the following hypnotic agents (Thiopentone 4-7 mg/kg, Ketamine 0.5-2 mg/kg, Propofol 1-4 mg/kg, Midazolam 0.5-1 mg/kg, Sevoflurane up to 8%).
  • An opioid drug and anticholinergic can be chosen and administered at the discretion of the anaesthetist in charge.
  • A neuromuscular blocking agent (NMBA): Rocuronium 0.5-1 mg/kg, Cis Atracurium 0.2-0.5 mg/kg, Atracurium 0,5 mg/kg, Vecuronium 0.1 mg/kg, Mivacurium 0.2 - 0.3 mg/kg or Succinylcholine 2 mg/kg.

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.

02

Conditions studied

  • Intubation

Keywords

  • Artificial Intelligence
  • Tracheal video intubation
  • larynGuide
  • Airway management
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
6 Months to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Inclusion criteria

  • male or female pediatric patients ≥ 6 months to ≤ 6 years,
  • (ASA) class I to III
  • undergoing elective surgery in general anaesthesia with tracheal intubation.

Exclusion criteria

Exclusion Criteria:

  • for intubation with C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany)
  • Patients \< 6 months or > 6 years
  • No proper trained personnel for the device at the study site
  • Expected impossible mask ventilation.
  • High risk of aspiration (requiring rapid sequence induction and intubation)
  • Intracranial surgery
  • Limited knowledge of German language or refusing .
Terms in these criteria, in plain language(3)

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.

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.

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.

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.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
110 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Pediatric patients (≥ 6 months to ≤ 6 years) undergoing elective surgery

    Pediatric patients (≥ 6 months to ≤ 6 years) undergoing elective surgery surgery in general anaesthesia with tracheal intubation

    Device: LarynGuide

Interventions

  • DeviceLarynGuide

    Artificial Intelligence assisted tracheal video intubation in children

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Overall success rate

    Overall success rate under assistance with larynGuide™

    Time frame: 5 minutes

  2. first-attempt success rate

    First-attempt oro-tracheal intubation success rate confirmed with waveform capnography in percentage

    Time frame: 10 minutes

  3. Number of attempts

    number of attempts until correct intubation

    Time frame: 5 minutes

  4. 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

  5. Percentage of glottic opening (POGO)

    Best percentage of glottic opening (POGO)

    Time frame: 2 minutes

  6. 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

  7. 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

07

Study locations

1 site
08

References and documents

Publications

  • Fuchs A, Raeber A, Lippuner R, Weber L, Borysenko Y, Huber M, Greif R, Riva T. Artificial intelligence-assisted tracheal intubation in humans: a prospective observational study of diagnostic accuracy. Anaesthesia. 2026 Mar;81(3):343-350. doi: 10.1111/anae.70063. Epub 2025 Nov 17. PubMed 41243690 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07922434
Responsible party
Sponsor
First posted
Nov 6, 2026
Start date
Nov 2026 (estimated)
Primary completion
Oct 31, 2027 (estimated)
Completion
Apr 30, 2028 (estimated)
Last update
Nov 6, 2026

Study contacts

Alexander Fuchs, PD Dr. med.
Contact
alexander.fuchs@insel.ch
+41 31 632 23 84
Thomas Riva, Prof. Dr. med.
Contact
thomas.riva@insel.ch
+41 31 632 27 25

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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