Ignite Creation Date:
2025-12-25 @ 12:29 AM
Ignite Modification Date:
2025-12-25 @ 10:35 PM
Study NCT ID:
NCT02743767
Status:
COMPLETED
Last Update Posted:
2016-11-10
First Post:
2016-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Frequency of Airway Complications During General Anaesthesia After Introducing Five Handling Adaptations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7455}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-09', 'studyFirstSubmitDate': '2016-04-05', 'studyFirstSubmitQcDate': '2016-04-14', 'lastUpdatePostDateStruct': {'date': '2016-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of airway complications after introducing five treatment adaptations', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'Postoperative side effects after routinely general anaesthesia', 'timeFrame': '2 months'}, {'measure': 'Frequency of reporting critical incident (CIRS)', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Airway management', 'General anaesthesia', 'Critical incidents', 'Complications'], 'conditions': ['Airway Complications']}, 'referencesModule': {'references': [{'pmid': '36564247', 'type': 'DERIVED', 'citation': 'Huber M, Greif R, Pedersen TH, Theiler L, Kleine-Brueggeney M. Risk patterns of consecutive adverse events in airway management: a Bayesian network analysis. Br J Anaesth. 2023 Mar;130(3):368-378. doi: 10.1016/j.bja.2022.11.007. Epub 2022 Dec 22.'}, {'pmid': '34535275', 'type': 'DERIVED', 'citation': 'Pedersen TH, Ueltschi F, Hornshaw T, Greif R, Theiler L, Huber M, Kleine-Brueggeney M. Optimisation of airway management strategies: a prospective before-and-after study on events related to airway management. Br J Anaesth. 2021 Nov;127(5):798-806. doi: 10.1016/j.bja.2021.07.030. Epub 2021 Sep 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if five simple adaptations in airway management of patients undergoing general anaesthesia can reduce minor and major airway complications.\n\nAfter a first detection of causes of airway complications during general anaesthesia investigators initiated five different interventions in airway management, which were: immediate bag-valve mask ventilation after administering of muscle relaxants, optimized preoxygenation, introducing of a preinterventional checklist, increased usage of video laryngoscopy and immediate change of provider in case of failed intubation.\n\nIn a second phase of this observational study investigators want to evaluate if these five interventions can reduce minor and major airway complications during general anaesthesia.\n\nAdditionally, investigators want to record how many critical incidents (CIRS) occur during this observational period and how many of them will be reported by the involved stuff.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must receive a general anaesthesia with any form of airway management\n\nExclusion Criteria:\n\n* Anaesthesia without airway management\n* Patients who do not give or who withdraw general consent'}, 'identificationModule': {'nctId': 'NCT02743767', 'acronym': 'Papaya', 'briefTitle': 'Frequency of Airway Complications During General Anaesthesia After Introducing Five Handling Adaptations', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Frequency of Airway Complications During General Anaesthesia After Introducing Five Handling Adaptations', 'orgStudyIdInfo': {'id': 'PAPAYA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Before interventions', 'description': 'Only observational activity for this arm, to record the frequency and triggering factors of airway complications during general anaesthesia.'}, {'type': 'EXPERIMENTAL', 'label': 'After interventions', 'description': 'After introducing five different treating adaptations in airway management we want to record the frequency of airway complications during general anaesthesia.', 'interventionNames': ['Procedure: Introducing five different treating adaptations']}], 'interventions': [{'name': 'Introducing five different treating adaptations', 'type': 'PROCEDURE', 'description': 'Immediate Bag-valve mask ventilation after administering of muscle relaxants, optimized preoxygenation, introducing of a preinterventional checklist, increased usage of video laryngoscopy and immediate hand alternately if frustrated intubation.', 'armGroupLabels': ['After interventions']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-3010', 'city': 'Bern', 'state': 'Canton of Bern', 'country': 'Switzerland', 'facility': 'University Hospital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Robert Greif, MD MME FERC', 'role': 'STUDY_CHAIR', 'affiliation': 'Insel Gruppe AG, University Hospital Bern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}