Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 12:29 AM
Study NCT ID:
NCT05850260
Status:
COMPLETED
Last Update Posted:
2024-10-22
First Post:
2023-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
McGrath Video Laryngoscope for All Intubations in the Operating Room
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5220}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-18', 'studyFirstSubmitDate': '2023-04-18', 'studyFirstSubmitQcDate': '2023-04-28', 'lastUpdatePostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '"easy intubation"', 'timeFrame': 'during intubation', 'description': 'To compare "easy intubation" in the two study periods. "Easy intubation" defined as intubation at the first attempt, modified Cormack-Lehane grades of I or IIa and absence of need of adjuvant airway devices for intubation. (percentage)'}], 'secondaryOutcomes': [{'measure': 'Intubations at the first attempt', 'timeFrame': 'during intubation', 'description': 'To compare difference in the incidence of intubations at the first attempt in the two periods studied. (percentage)'}, {'measure': 'Number of intubations attempts', 'timeFrame': 'during intubation', 'description': 'To compare number of intubations attempts in the two periods studied'}, {'measure': 'Modified Cormack-Lehane grade of glottic view', 'timeFrame': 'during intubation', 'description': 'To compare Modified Cormack-Lehane grade of glottic view in the two periods studied Modified Cormack-Lehane grade of glottic view:I: full view of the glottis IIa: partial view of the glottis IIb: arytenoid or posterior part of the vocal cords just visible III: only epiglottis visible IV: neither glottis nor epiglottis visible'}, {'measure': 'Need of adjuvant airway devices for intubation', 'timeFrame': 'during intubation', 'description': 'To compare need of adjuvant airway devices for intubation in the two periods studied airway devices for intubation: bougie, videolaryngoscope, others)'}, {'measure': 'Operator-assessed subjective difficulty', 'timeFrame': 'during intubation', 'description': 'To compare degree of subjective difficulty experienced by the operator in the two periods studied.\n\nSubjective difficulty of intubation by means of a special analogue numerical scale from 0 to 10, where 0=no subjective difficulty and 10=maximal subjective difficulty'}, {'measure': 'Complications during intubation', 'timeFrame': 'Participants will be followed from the beginning of the intervention to 30 minutes after the intervention', 'description': 'To compare percentage of complications associated with the intubation in the two periods studied'}, {'measure': 'Overall success rate intubation', 'timeFrame': 'During intubation', 'description': 'To compare the difference overall success rate intubation (percentage) with the first device used in each period'}, {'measure': 'Need to change the device for intubation', 'timeFrame': 'During intubation', 'description': 'To compare the need to change the device for intubation in the two periods studied'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diificult intubation', 'videolaryngoscope', 'airway'], 'conditions': ['Intubation Complication']}, 'referencesModule': {'references': [{'pmid': '35820934', 'type': 'BACKGROUND', 'citation': 'Hansel J, Rogers AM, Lewis SR, Cook TM, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adults undergoing tracheal intubation: a Cochrane systematic review and meta-analysis update. Br J Anaesth. 2022 Oct;129(4):612-623. doi: 10.1016/j.bja.2022.05.027. Epub 2022 Jul 9.'}, {'pmid': '35811139', 'type': 'BACKGROUND', 'citation': 'De Jong A, Sfara T, Pouzeratte Y, Pensier J, Rolle A, Chanques G, Jaber S. Videolaryngoscopy as a first-intention technique for tracheal intubation in unselected surgical patients: a before and after observational study. Br J Anaesth. 2022 Oct;129(4):624-634. doi: 10.1016/j.bja.2022.05.030. Epub 2022 Jul 8.'}, {'pmid': '29397126', 'type': 'BACKGROUND', 'citation': 'Cook TM, Boniface NJ, Seller C, Hughes J, Damen C, MacDonald L, Kelly FE. Universal videolaryngoscopy: a structured approach to conversion to videolaryngoscopy for all intubations in an anaesthetic and intensive care department. Br J Anaesth. 2018 Jan;120(1):173-180. doi: 10.1016/j.bja.2017.11.014. Epub 2017 Nov 21.'}, {'pmid': '29397120', 'type': 'BACKGROUND', 'citation': 'Cooper RM. Implementing universal videolaryngoscopy: how to do it and what to expect. Br J Anaesth. 2018 Jan;120(1):13-15. doi: 10.1016/j.bja.2017.11.017. Epub 2017 Nov 21. No abstract available.'}, {'pmid': '39542091', 'type': 'DERIVED', 'citation': 'Taboada M, Estany-Gestal A, Rama-Maceiras P, Orallo MA, Bermudez M, Barreiro C, Gomez L, Amor M, Otero F, Fernandez J, Molins N, Amate JJ, Bascuas B, Rey R, Alonso MC, Castro MJ, Sarmiento A, Dos Santos L, Nieto C, Paredes S, Velasco A, Taboada C, Martin L, Campana D, Mosquera E, Novoa C, Varela S, da Silva L, Dominguez E, Bedoya A, Gomez AI, Estevez M, Martinez P, Sotojove R, Naveiro A, Diaz C, Ruido R, Miron P, Gonzalez M, Francisco C, Regueira J, Peiteado M, Eiras M, Paz E. Impact of universal use of the McGrath videolaryngoscope as the first option for all intubations in the operating room: The multicentre prospective before-after VIDEOLAR-SURGERY study protocol. Rev Esp Anestesiol Reanim (Engl Ed). 2025 Jan;72(1):101649. doi: 10.1016/j.redare.2024.101649. Epub 2024 Nov 12.'}]}, 'descriptionModule': {'briefSummary': 'Tracheal intubation is a very common procedure performed in the operating room. The usual intubation technique in the operating room is based on direct laryngoscopy, using a standard Macintosh laryngoscope. Although in most patients there are no complications during intubation, more than 90% of difficult tracheal intubations in the operate room are unpredictable, and several authors, recommend the universal use of the videolaryngoscope for all intubations, using as the first intubation option regardless of whether the patient has predictors of a difficult airway or no.The authors do not know whether providing a own videolaryngoscope to each anesthesiologist to use as the first option for intubation in all patients who need it in the operating room improves the percentage of patients with easy intubation and decrease the incidence of complications.', 'detailedDescription': "Tracheal intubation is a very common procedure performed in the operating room. The usual intubation technique in the operating room is based on direct laryngoscopy, using a standard Macintosh laryngoscope. Although in most patients there are no complications during intubation, more than 90% of difficult tracheal intubations in the operate room are unpredictable, and several authors, recommend the universal use of the videolaryngoscope for all intubations, using as the first intubation option regardless of whether the patient has predictors of a difficult airway or no. The authors do not know whether providing a personal videolaryngoscope to each anesthesiologist to use as the first option for intubation in all patients who need it in the operating room improves the percentage of patients with easy intubation and decrease the incidence of complications.\n\nThe VIDEOLAR-SURGERY trial is a prospective, observational, open-label, multicenter study, with before-after analysis. Consecutive patients requiring tracheal intubation for an elective o urgent surgical intervention from a period of 14 months by one of the 35 researcher's anesthesiologists assigned will be recruited. In the pre-implementation period (6 months), the 35 anesthesiologists will perform all tracheal intubations using the standard Macintosh direct laryngoscope as a first intubation option. During the implementation period (2 months), a personal McGrath videolaryngoscope will be provided to each anesthesiologist to train in its use. During the post-implementation period (6 months), the 35 anesthesiologists will perform all tracheal intubations using their personal McGrath Mac videolaryngoscope as a first intubation option. The main objective is to evaluate whether the use of a own McGrath videolaryngoscope by anesthesiologists, as the first intubation option, improves the percentage of patients with easy intubation compared with the standard Macintosh laryngoscope. Secondary objectives are to compare incidence of first-attempt intubation, laryngoscopic vision, need of adjuvant airway devices, difficulty, and complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients who need to be tracheal intubated for an elective o urgent surgical intervention from a period of 14 months by one of the 35 anesthesiologists assigned by the Anesthesiology Services of the 8 Hospitals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older\n* Patients who need to be tracheal intubated for a surgical intervention in the surgical area.\n\nExclusion Criteria:\n\n* Patients who are intubated in a place other than the surgical area (Intensive Care, Emergency, Hospitalization floor) will not be included.'}, 'identificationModule': {'nctId': 'NCT05850260', 'acronym': 'VIDEO-SURG', 'briefTitle': 'McGrath Video Laryngoscope for All Intubations in the Operating Room', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinico Universitario de Santiago'}, 'officialTitle': 'Effect of Providing a Personal McGrath Video Laryngoscope to Anesthesiologists for All Intubations in the Operating Room: a Multicentre Prospective Observational, Before-after Study', 'orgStudyIdInfo': {'id': 'VIDEOLAR-SURGERY'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Macintosh laryngoscope', 'description': 'During the pre-implementation period (6 months), the 35 assigned attending anesthetists will perform all tracheal intubations in the operation room according to the standard of care using the standard Macintosh direct laryngoscope as a first intubation option', 'interventionNames': ['Device: Macintosh laryngoscope']}, {'label': 'McGrath Mac videolaryngoscope', 'description': 'During the post-implementation period (6 months), the 35 assigned attending anesthetists will perform all tracheal intubations using their personal McGrath Mac videolaryngoscope as a first intubation option', 'interventionNames': ['Device: Videolaryngoscope']}], 'interventions': [{'name': 'Macintosh laryngoscope', 'type': 'DEVICE', 'description': 'During the pre-implementation period (6 months), the 35 assigned attending anesthetists will perform all tracheal intubations in the operation room according to the standard of care using the standard Macintosh direct laryngoscope as a first intubation option', 'armGroupLabels': ['Macintosh laryngoscope']}, {'name': 'Videolaryngoscope', 'type': 'DEVICE', 'description': 'During the post-implementation period (6 months), the 35 assigned attending anesthetists will perform all tracheal intubations using their personal McGrath Mac videolaryngoscope as a first intubation option.', 'armGroupLabels': ['McGrath Mac videolaryngoscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15866', 'city': 'Santiago de Compostela', 'state': 'A Coruña', 'country': 'Spain', 'facility': 'Manuel Taboada', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}], 'overallOfficials': [{'name': 'Manuel Taboada Muñiz, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Clinical Hospital of Santiago de Compostela'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'When available: With publication', 'ipdSharing': 'YES', 'description': 'Data types: Deidentified participant data How to access data: Requests must be sent to manutabo@yahoo.es When available: With publication Additional Information Who can access the data: Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose Mechanisms of data availability: With investigator support', 'accessCriteria': 'Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinico Universitario de Santiago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Profesor', 'investigatorFullName': 'Manuel Taboada Muñiz', 'investigatorAffiliation': 'Hospital Clinico Universitario de Santiago'}}}}