Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-27 @ 10:10 PM
Study NCT ID:
NCT06397261
Status:
COMPLETED
Last Update Posted:
2025-05-14
First Post:
2024-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LarynGuide™ Assisted Tracheal Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2024-04-29', 'studyFirstSubmitQcDate': '2024-04-29', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of correct assessment given by larynGuide™', 'timeFrame': '5 minutes', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Overall success rate', 'timeFrame': '5 minutes', 'description': 'Overall success rate under assistance with larynGuide™'}, {'measure': 'first-attempt success rate', 'timeFrame': '10 minutes', 'description': 'First-attempt oro-tracheal intubation success rate confirmed with waveform capnography in percentage'}, {'measure': 'Number of attempts', 'timeFrame': '5 minutes', 'description': 'number of attempts until correct intubation'}, {'measure': 'Number of incidents of technical problems of larynGuide™', 'timeFrame': '10 minutes', 'description': 'Number of the occurrence of any technical problem of the larynGuide™, a software for artificial intelligence assisted tracheal intubation (aiEndoscopic, Zürich, Switzerland)'}, {'measure': 'Percentage of glottic opening', 'timeFrame': '2 minutes', 'description': 'Best percentage of glottic opening (POGO)'}, {'measure': 'Rate of Cormack & Lehane Score from 1 to 4', 'timeFrame': '2 minutes', 'description': '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.'}, {'measure': 'Occurrence rate of airway management complications', 'timeFrame': '5 minutes', 'description': '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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Artificial Intelligence', 'Tracheal video intubation', 'larynGuide'], 'conditions': ['Intubation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Eligible patients will be prepared for intubation according to the local SOPs of the anesthesia departments with mandatory monitoring of SpO2, HR, NIBP, EtCO2.\n\nFor 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:\n\n* Hypnotic agent (Propofol 1-4 mg/kg).\n* Opioids (Fentanyl 1-3 mcg/kg, Remifentanyl 1-3 mcg/kg).\n* 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.\n\nTracheal 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).\n\nFor 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'german speaking adult patients classified ASA I, II or III undergoing surgery (except intracranial surgery) in general anaesthesia with tracheal intubation without contraindication for intubation with C-mac or indication for impossible mask ventilation and high aspiration risk with given informend consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female patients ≥18 years\n* ASA class I to III\n* undergoing elective surgery in general anesthesia with tracheal intubation\n\nExclusion Criteria:\n\n* Contraindication for intubation with C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) with a Macintosh nr 3 or 4 blade\n* Patients \\< 18 years\n* No proper trained personnel for the device at the study site\n* Expected impossible mask ventilation.\n* High risk of aspiration (requiring rapid sequence induction intubation)\n* Intracranial surgery\n* Limited knowledge of German language or refusing informed consent'}, 'identificationModule': {'nctId': 'NCT06397261', 'acronym': 'LarynGuide', 'briefTitle': 'LarynGuide™ Assisted Tracheal Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Artificial Intelligence Assisted Tracheal Video Intubation: an Observational Trial About Correctness of LarynGuide™', 'orgStudyIdInfo': {'id': 'LarynGuide'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'adult patients undergoing elective surgery', 'description': 'adult patients undergoing elective surgery requiring tracheal intubation', 'interventionNames': ['Device: LarynGuide']}], 'interventions': [{'name': 'LarynGuide', 'type': 'DEVICE', 'description': 'Artificial Intelligence assisted tracheal video intubation', 'armGroupLabels': ['adult patients undergoing elective surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'state': 'Canton of Bern', 'country': 'Switzerland', 'facility': 'Inselspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Thomas Riva, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bern Univerisity Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'aiEndsoscopic', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Thomas Riva', 'investigatorFullName': 'Thomas Riva', 'investigatorAffiliation': 'Insel Gruppe AG, University Hospital Bern'}}}}