Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-26 @ 11:16 PM
Study NCT ID:
NCT05197868
Status:
COMPLETED
Last Update Posted:
2022-02-15
First Post:
2021-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Applied Forces During Neonatal Intubation
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-31', 'studyFirstSubmitDate': '2021-11-28', 'studyFirstSubmitQcDate': '2022-01-05', 'lastUpdatePostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forces applied to the epiglottis', 'timeFrame': '5 minutes', 'description': "The peak force (maximum force, expressed as Newton) applied on the epiglottis during intubation will be recorded by sensors positioned on the tip of the laryngoscope's blade."}], 'secondaryOutcomes': [{'measure': 'Forces applied to the palate', 'timeFrame': '5 minutes', 'description': "The peak force (maximum force, expressed as Newton) applied on the palate during intubation will be recorded by sensors positioned on the posterior side of the laryngoscope's blade."}, {'measure': 'Perceived workload during intubation', 'timeFrame': '20 minutes', 'description': 'Participants will be asked to report their perceived workload during intubation by using a validated tool'}, {'measure': 'Time of intubation', 'timeFrame': '5 minutes', 'description': 'Time elapsed frmo insertion of the laryngoscope in the mouth to his removal'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intubation', 'Training', 'Neonate', 'Manikin']}, 'referencesModule': {'references': [{'pmid': '28319487', 'type': 'RESULT', 'citation': 'Balaban O, Tobias JD. Videolaryngoscopy in Neonates, Infants, and Children. Pediatr Crit Care Med. 2017 May;18(5):477-485. doi: 10.1097/PCC.0000000000001128.'}, {'pmid': '32152886', 'type': 'RESULT', 'citation': 'Gordon JK, Bertram VE, Cavallin F, Parotto M, Cooper RM. Direct versus indirect laryngoscopy using a Macintosh video laryngoscope: a mannequin study comparing applied forces. Can J Anaesth. 2020 May;67(5):515-520. doi: 10.1007/s12630-020-01583-x. Epub 2020 Mar 9.'}, {'pmid': '29980290', 'type': 'RESULT', 'citation': 'Pouppirt NR, Nassar R, Napolitano N, Nawab U, Nishisaki A, Nadkarni V, Ades A, Foglia EE. Association Between Video Laryngoscopy and Adverse Tracheal Intubation-Associated Events in the Neonatal Intensive Care Unit. J Pediatr. 2018 Oct;201:281-284.e1. doi: 10.1016/j.jpeds.2018.05.046. Epub 2018 Jul 3.'}, {'pmid': '36788198', 'type': 'DERIVED', 'citation': 'Cavallin F, Sala C, Maglio S, Bua B, Villani PE, Menciassi A, Tognarelli S, Trevisanuto D. Applied forces with direct versus indirect laryngoscopy in neonatal intubation: a randomized crossover mannequin study. Can J Anaesth. 2023 May;70(5):861-868. doi: 10.1007/s12630-023-02402-9. Epub 2023 Feb 14.'}]}, 'descriptionModule': {'briefSummary': 'This study will be to compare the forces applied to mannequin airways (at epiglottis and at palate) during direct laryngoscopy and indirect video laryngoscopy with two kinds of blades (straight blade and hyper-angulated blade)', 'detailedDescription': 'This is a randomized controlled crossover trial of intubation with three laryngoscope devices in a neonatal manikin model. Level III NICU and PICU consultants, pediatric residents, anesthesiology consultants, and anesthesiology residents will be eligible to participate in the study. Participants in the ABC arm will be assigned to perform the intubation with a traditional laryngoscope (A), followed by the intubation with a straight blade video laryngoscope (B) and by the intubation with hyper-angulated video laryngoscope (C). Participants in different arms will be assigned to perform the intubations in different sequences (BCA/CAB/ACB/BAC/CBA). The primary outcome measure will be the forces applied to mannequin oro-tracheal tissues during intubation with the three kinds of tools. The secondary outcome measures will be the perceived workload during intubation and intubation time with the traditional laryngoscope and the video laryngoscope.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Level III NICU and PICU consultants, pediatric residents, anesthesiology consultants, and anesthesiology residents will be eligible to participate in the study.\n\nExclusion Criteria:\n\n* Refusal to participate.'}, 'identificationModule': {'nctId': 'NCT05197868', 'briefTitle': 'Applied Forces During Neonatal Intubation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Padova'}, 'officialTitle': 'Applied Forces During Neonatal Intubation: a Randomized Crossover Mannequin Study', 'orgStudyIdInfo': {'id': 'NEOUNIPD1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intubation with traditional laryngoscope', 'description': 'Participants will be required to intubate the manikin by using a traditional laryngoscope', 'interventionNames': ['Procedure: Intubation with traditional laryngoscope']}, {'type': 'EXPERIMENTAL', 'label': 'Intubation with a straight blade video laryngoscope', 'description': 'Participants will be required to intubate the manikin by using a straight blade video laryngoscope', 'interventionNames': ['Procedure: Intubation with a straight blade video laryngoscope']}, {'type': 'EXPERIMENTAL', 'label': 'Intubation with hyper-angulated video laryngoscope', 'description': 'Participants will be required to intubate the manikin by using a hyper-angulated video laryngoscope', 'interventionNames': ['Procedure: Intubation with a hyper-angulated video laryngoscope']}], 'interventions': [{'name': 'Intubation with traditional laryngoscope', 'type': 'PROCEDURE', 'description': 'Participants will be invited to intubate the mannequin with a traditional laryngoscope', 'armGroupLabels': ['Intubation with traditional laryngoscope']}, {'name': 'Intubation with a straight blade video laryngoscope', 'type': 'PROCEDURE', 'description': 'Intubation with a straight blade video laryngoscope', 'armGroupLabels': ['Intubation with a straight blade video laryngoscope']}, {'name': 'Intubation with a hyper-angulated video laryngoscope', 'type': 'PROCEDURE', 'description': 'Participants will be asked to intubate the mannequin with a hyper-angulated video laryngoscope', 'armGroupLabels': ['Intubation with hyper-angulated video laryngoscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'University Hospital of Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Padova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Daniele Trevisanuto', 'investigatorAffiliation': 'University Hospital Padova'}}}}