Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT03747250
Status:
COMPLETED
Last Update Posted:
2021-03-23
First Post:
2018-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Videolaryngoscopy vs. Direct Laryngoscopy for Elective Airway Management in Pediatric Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The allocation to the group will be randomized in located in closed envelope, that will be opened in the operating theater before anesthesia induction'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 501}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-22', 'studyFirstSubmitDate': '2018-11-16', 'studyFirstSubmitQcDate': '2018-11-16', 'lastUpdatePostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First intubation attempt success rate', 'timeFrame': 'Intraoperatively', 'description': 'Success rate of the first intubation attempt'}], 'secondaryOutcomes': [{'measure': 'Time for successful intubation', 'timeFrame': 'Intraoperatively', 'description': 'Time need for intubation from decision to intubate to first end-tidal CO2 wave'}, {'measure': 'Overall intubation success rate', 'timeFrame': 'Intraoperatively', 'description': 'Success rate fot intubation'}, {'measure': 'Laryngeal view', 'timeFrame': 'Intraoperatively', 'description': 'Laryngeal view scored by Cormack-Lehane grading system'}, {'measure': 'Complications', 'timeFrame': 'Intraoperatively', 'description': 'Incidence of associated complications during anesthesia induction - desaturation, bradycardia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Videolaryngoscopy', 'Laryngoscopy', 'Tracheal intubation', 'Success rate'], 'conditions': ['Tracheal Intubation Morbidity']}, 'referencesModule': {'references': [{'pmid': '34560686', 'type': 'DERIVED', 'citation': 'Klabusayova E, Klucka J, Kosinova M, Toukalkova M, Stoudek R, Kratochvil M, Marecek L, Svoboda M, Jabandziev P, Urik M, Stourac P. Videolaryngoscopy vs. Direct Laryngoscopy for Elective Airway Management in Paediatric Anaesthesia: A prospective randomised controlled trial. Eur J Anaesthesiol. 2021 Nov 1;38(11):1187-1193. doi: 10.1097/EJA.0000000000001595.'}]}, 'descriptionModule': {'briefSummary': 'Videolaryngoscopy can lead to superior airway conditions and to the possible higher success compared to standard direct laryngoscopy. Patient will be randomized to the interventional group (videolaryngoscopy) and control group (direct laryngoscopy). The first attempt success rate, time to first end-tidal CO2 (ETCO2) wave, overall success rate, incidence of aspiration, bradycardia, desaturation a overall complications will be monitored.', 'detailedDescription': 'Videolaryngoscopy is specialized equipment for airway management, where a camera located at the tip of the laryngoscope blade can visualize also structures that can´t be seen on direct laryngoscopy, co the operator can obtain superior view of aditus laryngis during intubation. Currently videolaryngoscopy is not routinely used for intubation and it is reserved for patients with difficult airway. The aim of the trial is to compare the elective use of videolaryngoscopy versus direct laryngoscopy for elective airway management (tracheal intubation). Patients after informed consent approval will be randomized to the interventional group (videolaryngoscopy) and control group (laryngoscopy). The randomization will be managed by the Institute of Biostatistics and Analyses by the Faculty of medicine, Masaryk university. The primary aim will be the first intubation attempt success rate, the secondary aims will be time to successful intubation (time to first ETCO2 wave), overall success rate, number of intubation attempts, incidence of aspiration, desaturation and incidence of overall complications in all operators, in trainees, residents (5-10 years of practice), consultants (10-15 years of clinical practice) and consultants with over 15 years of clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '29 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients scheduled for elective surgery\n* Planned tracheal intubation for airway management during surgery\n* Signed informed consent\n\nExclusion Criteria:\n\n* Emergency surgery\n* Other airway management plan\n* age outside the predefined limits\n* Informed consent not signed'}, 'identificationModule': {'nctId': 'NCT03747250', 'acronym': 'Videoscopy', 'briefTitle': 'Videolaryngoscopy vs. Direct Laryngoscopy for Elective Airway Management in Pediatric Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Brno University Hospital'}, 'officialTitle': 'Videolaryngoscopy Versus Direct Laryngoscopy for Elective Airway Management in Pediatric Anesthesia: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KDAR FN Brno 2018/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Videolaryngoscopy', 'description': 'Pediatric patients undergoing elective surgery with planned tracheal intubation for airway management. The tracheal intubation will be performed with the use of videolaryngoscope', 'interventionNames': ['Device: Videolaryngoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Direct laryngoscopy', 'description': 'Pediatric patients undergoing elective surgery with planned tracheal intubation for airway management. The tracheal intubation will be performed with the use of direct laryngoscopy', 'interventionNames': ['Device: Direct laryngoscopy']}], 'interventions': [{'name': 'Videolaryngoscopy', 'type': 'DEVICE', 'description': 'In experimental group (interventional group), patients will be intubated with the videolaryngoscope', 'armGroupLabels': ['Videolaryngoscopy']}, {'name': 'Direct laryngoscopy', 'type': 'DEVICE', 'description': 'In control group (active comparator group), patients will be intubated with the direct laryngoscope', 'armGroupLabels': ['Direct laryngoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62500', 'city': 'Brno', 'state': 'Czech Republic', 'country': 'Czechia', 'facility': 'University Hospital Brno - FN Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}], 'overallOfficials': [{'name': 'Petr Štourač, assoc.Prof.MD.Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'KDAR FN Brno'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brno University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assoc.prof.MD,Ph.D', 'investigatorFullName': 'Petr Štourač, MD', 'investigatorAffiliation': 'Brno University Hospital'}}}}