Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-03-01 @ 6:29 AM
Study NCT ID:
NCT05902858
Status:
UNKNOWN
Last Update Posted:
2023-06-15
First Post:
2023-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Standard Laryngoscopy Versus Video-laryngoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007440', 'term': 'Intubation'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'open-label, randomized, 3-parallel arm, monocentric trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-05', 'studyFirstSubmitDate': '2023-01-23', 'studyFirstSubmitQcDate': '2023-06-05', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate on first intubation attemps', 'timeFrame': 'During the procedure', 'description': 'The first-attempt intubation success is defined as tracheal tube placement with a single maneuver after insertion of the tube in the mouth. Reinsertion of the tube in the mouth counts as an additional attempt.'}], 'secondaryOutcomes': [{'measure': 'Time of intubation', 'timeFrame': 'During the procedure', 'description': 'Time from insertion of the laryngoscope beyond the dental rhyme to cuffed tube'}, {'measure': 'Time of laryngoscopy', 'timeFrame': 'During the procedure', 'description': 'Time from insertion of the laryngoscope beyond the dental rhyme to the insertion of the tube beyond the dental rhyme'}, {'measure': 'Number of intubation attempts', 'timeFrame': 'During the procedure', 'description': 'Times of reinsertion of the tube beyond the dental rhyme'}, {'measure': 'Complications', 'timeFrame': 'During the procedure', 'description': 'Evaluation of the type and rate of complications, including desaturation \\< 90%, esophageal intubation, tooth breakage and bleeding from the oropharyngeal mucosa'}, {'measure': 'Use of "jaw trust" or "BURP"', 'timeFrame': 'During the procedure', 'description': 'Need to perform adjuvant maneuvers (jaw trust or BURP), measured with yes/no'}, {'measure': 'Need of another anesthesiologist intervention', 'timeFrame': 'During the procedure', 'description': 'Required intervention of another anesthesiologist, measured with yes/no, after 3 failed intubation attempt or after request of the first anesthesiologist'}, {'measure': 'Needs to change the path of the intubation strategy', 'timeFrame': 'During the procedure', 'description': 'Needs to change intubation strategy, measured with yes/no, includes use of fiberoptic intubation, change of videolaryngoscope or postpone intervention'}, {'measure': 'Learning curve analysis of intubation rate success', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Improvement of intubation rate success'}, {'measure': 'Learning curve analysis of time of procedure', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Improvement of time of procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PROVU', 'Videolaryngoscopy', 'Laryngoscopy'], 'conditions': ['Difficult Intubation']}, 'referencesModule': {'references': [{'pmid': '33817645', 'type': 'BACKGROUND', 'citation': 'Harrison SL, Ahmad I, Elwen F, Curtis A, Dua G, Surda P, Johnstone C. Awake tracheal intubation with the ProVu video stylet: a case series. Anaesth Rep. 2021 Mar 29;9(1):e12102. doi: 10.1002/anr3.12102. eCollection 2021 Jan-Jun.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this open-label, randomized, 3-parallel arm trial is to compare success of intubation rate at first try between three groups that will be intubated:\n\n1. Conventional intubation with hyperangulated videolaryngoscope (control group),\n2. Intubation ProVu TM video stylet combined with hyperangulated videolaryngoscope,\n3. Intubation ProVu TM video stylet combined with standard Macintosh laryngoscope.', 'detailedDescription': 'Critical anesthetic incidents in the operating room are often related to airway management. Difficult airway management is defined as the clinical situation in which an anesthesiologist with conventional training has difficulty with upper airway face mask ventilation, difficulty with tracheal intubation, or both. Airway management has undergone a major transformation since the development of hyper-angle videolaryngoscopy (VL). Recently, the ProVuTM video stylet (Flexicare Medical Ltd, Mountain Ash, UK), which combines visualization technology with a tube guidance system, has been proposed as a new device for endotracheal intubation in participants with difficult airway management.\n\nThe investigators hypothesized that the ProVuTM video stylet combined with videolaryngoscopy or standard laryngoscopy may improve the success rate of intubation on the first attempt compared with using a videolaryngoscope alone in patientes with predicted difficult intubation. In fact, using ProVuTM the position of the video stylet tip can be adjusted continuously during the tracheal intubation maneuver.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing elective surgery requiring oral tracheal intubation;\n* ≥18 years of age;\n* simplified Arné score ≥11;\n* Written informed consent will be obtained from every participant.\n\nExclusion Criteria:\n\n* ≤18 years of age\n* interincisor distance at maximal mouth opening ≤2 cm;\n* planned awake fiberoptic intubation because patients are patients considered to be high-risk for difficult intubation or difficult mask ventilation (e.g. with neck tumours, complete cervical arthrodesis; neck circumference \\>50 cm);\n* patients at risk of gastric aspiration\n* planned nasal intubation.'}, 'identificationModule': {'nctId': 'NCT05902858', 'acronym': 'PROVU', 'briefTitle': 'Effect of Standard Laryngoscopy Versus Video-laryngoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria'}, 'officialTitle': 'Efferct of Standard Laryngoscopy Versus Video-laryngoscop on First-attempt Success in Difficult Airways Undergoing ProVu TM Video Stylet Guided Intubationa (PROVU)', 'orgStudyIdInfo': {'id': 'ASO.RianGen.22.03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Conventional intubation with hyperangulated videolaryngoscope', 'interventionNames': ['Device: Conventional intubation with hyperangulated videolaryngoscope']}, {'type': 'EXPERIMENTAL', 'label': 'Provu TM video stylet + hyperangulated videolaryngoscope', 'description': 'Intubation ProVu TM video stylet combined with hyperangulated videolaryngoscope', 'interventionNames': ['Device: Intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope']}, {'type': 'EXPERIMENTAL', 'label': 'Provu TM video stylet + Macintosh laryngoscope', 'description': 'Intubation ProVu TM video stylet combined with standard Macintosh laryngoscope', 'interventionNames': ['Device: Intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope']}], 'interventions': [{'name': 'Conventional intubation with hyperangulated videolaryngoscope', 'type': 'DEVICE', 'description': 'After the induction of general anesthesia, the patient will undergo conventional intubation with hyperangulated videolaryngoscope', 'armGroupLabels': ['Control Group']}, {'name': 'Intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope', 'type': 'DEVICE', 'description': 'After the induction of general anesthesia, the patient will undergo intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope', 'armGroupLabels': ['Provu TM video stylet + hyperangulated videolaryngoscope']}, {'name': 'Intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope', 'type': 'DEVICE', 'description': 'After the induction of general anesthesia, the patient will undergo intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope', 'armGroupLabels': ['Provu TM video stylet + Macintosh laryngoscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15121', 'city': 'Alessandria', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}], 'overallOfficials': [{'name': 'Mirco Leo, Physician', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria', 'class': 'OTHER'}, 'collaborators': [{'name': 'Flexicare Medical Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}