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OpenTrials
Completed

NCT Number: NCT06397261

LarynGuide™ Assisted Tracheal Intubation

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inselspital

Bern, Canton of Bern, 3010, Switzerland

About this study

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:

  • Hypnotic agent (Propofol 1-4 mg/kg).
  • Opioids (Fentanyl 1-3 mcg/kg, Remifentanyl 1-3 mcg/kg).
  • Non-depolarizing muscle relaxant (Rocuronium 0.5-1 mg/kg). After induction of anesthesia and the administration of the muscle relaxant, bag-mask ventilation with FiO2 = 1.0 (flow rates of 18 Lmin-1) will be performed until apnea sets in. After induction all patients will be paralyzed to facilitate airway management. Neuromuscular blockade will be assessed by train-of-four monitoring. Thereafter oxygen administration, laryngoscopy and tracheal intubation are performed as usually.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male or female patients ≥18 years
  • ASA class I to III
  • undergoing elective surgery in general anesthesia with tracheal intubation

Exclusion criteria

  • Contraindication for intubation with C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) with a Macintosh nr 3 or 4 blade
  • Patients < 18 years
  • No proper trained personnel for the device at the study site
  • Expected impossible mask ventilation.
  • High risk of aspiration (requiring rapid sequence induction intubation)
  • Intracranial surgery
  • Limited knowledge of German language or refusing informed consent

Treatment and study plan

LarynGuide

Device

Artificial Intelligence assisted tracheal video intubation

Primary outcomes

  1. Rate of correct assessment given by larynGuide™

    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

Secondary outcomes

  1. Overall success rate

    Time frame: 5 minutes

    Overall success rate under assistance with larynGuide™

  2. first-attempt success rate

    Time frame: 10 minutes

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

  3. Number of attempts

    Time frame: 5 minutes

    number of attempts until correct intubation

  4. Number of incidents of technical problems of larynGuide™

    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)

  5. Percentage of glottic opening

    Time frame: 2 minutes

    Best percentage of glottic opening (POGO)

  6. Rate of Cormack & Lehane Score from 1 to 4

    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.

  7. Occurrence rate of airway management complications

    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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • aiEndsoscopic

Registry information

Official study title

Artificial Intelligence Assisted Tracheal Video Intubation: an Observational Trial About Correctness of LarynGuide™

Acronym: LarynGuide

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 2, 2024
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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