Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-28 @ 3:15 PM
Study NCT ID:
NCT05818332
Status:
RECRUITING
Last Update Posted:
2025-02-11
First Post:
2023-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ClassIntra® for Better Outcomes in Surgery - CIBOSurg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1800}, 'targetDuration': '90 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2023-03-15', 'studyFirstSubmitQcDate': '2023-04-17', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Qualitative conclusions', 'timeFrame': 'Longitudinal data collection before, during and after the implementation', 'description': 'Qualitative conclusions about the effectiveness of the employed implementation strategy.'}, {'measure': 'Characterising themes', 'timeFrame': 'Longitudinal data collection before, during and after the implementation', 'description': 'Themes characterising the factors that influenced the observed implementation processes, based on the results from the contextual analysis.'}, {'measure': 'Comprehensive Complication Index (CCI®)', 'timeFrame': 'Difference in CCI® before and after the implementation at hospital discharge and at 90 days after surgery', 'description': 'CCI® (Comprehensive Complication Index) is the weighted sum of all pAEs according to Clavien-Dindo. It will be assessed at hospital discharge and at 90 days after surgery.'}, {'measure': 'Severe iAEs according to ClassIntra®', 'timeFrame': 'Difference in number of severe iAEs before and after the implementation', 'description': 'Severe iAEs according to ClassIntra® are defined as greater than or equal to grade III.'}, {'measure': 'Total number of iAEs according to ClassIntra®', 'timeFrame': 'Difference in total number of iAEs before and after the implementation', 'description': 'Total number of iAEs according to ClassIntra® occurring in the baseline and the after implementation period.'}, {'measure': 'Severe pAEs according to Clavien-Dindo', 'timeFrame': 'Difference in number of severe iAEs before and after the implementation', 'description': 'Severe pAEs according to Clavien-Dindo are defined as greater than or equal to grade IIIa. They will be assessed at hospital discharge and at 90 days after surgery.'}, {'measure': 'Total number of pAEs according to Clavien-Dindo', 'timeFrame': 'Difference in total number of pAEs before and after the implementation', 'description': 'Total number of pAEs according to Clavien-Dindo occurred in the baseline and the after implementation period. They will be assessed at hospital discharge and at 90 days after surgery.'}, {'measure': 'Number of resulting actions due to the routine recording and discussion of iAEs during the sign-out', 'timeFrame': 'Difference in number of resulting actions before and after the implementation', 'description': 'Resulting actions are e.g. preventive measures for anticipated pAEs.'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Difference in length of hospital stay before and after the implementation', 'description': 'Length of hospital stay will be measured in days.'}], 'primaryOutcomes': [{'measure': 'Intervention fidelity - component checklist completion', 'timeFrame': '2 months after the end of the implementation', 'description': 'Checklist completion is defined as completeness of all ticks on the sign-out checklist taking into consideration the minimum standard.'}], 'secondaryOutcomes': [{'measure': 'Intervention fidelity - component quality of checklist performance', 'timeFrame': 'Up to four months after the implementation', 'description': 'Quality of the sign-out will be measured with the WHO behaviourally anchored rating scale (WHOBARS):\n\nQuality will be measured in a random sample of 20-25%, assessed in those centres with well-established sign-out in the baseline period and in all centres in the after-implementation phase.'}, {'measure': 'Implementation fidelity - Quantitative and qualitative evaluation of critical implementation steps', 'timeFrame': 'Up to four months after the implementation', 'description': 'Quantitative and qualitative evaluation of critical implementation steps followed or not (and why not) by each site, according to the proposed/designed implementation plan (template)'}, {'measure': 'Intervention acceptability - extent of perception among stakeholders that the intervention is agreeable or satisfactory', 'timeFrame': 'Measured after the implementation', 'description': 'Acceptability is the extent of perception among stakeholders that the intervention is agreeable or satisfactory. It will be measured according to the Acceptability of Intervention Measure (AIM).'}, {'measure': 'Adaptation - extent to which sign-out and documentation of iAEs have been locally adapted', 'timeFrame': 'Checklist and process modifications classified according to FRAME.', 'description': 'Adaptation is the extent to which sign-out and documentation of iAEs have been locally adapted. It will be measured by comparing the local checklists with the minimum standard sign-out.'}, {'measure': 'Appropriateness - extent to which staff perceive the intervention as being a good fit, relevant and compatible with their setting', 'timeFrame': 'Measured after the implementation', 'description': 'Appropriateness is the extent to which staff perceive the intervention as being a good fit, relevant and compatible with their setting. It will be measured by the Intervention Appropriateness Measure (IAM).'}, {'measure': 'Feasibility - extent to which sign-out and documentation of iAEs can be successfully used or carried out within a given setting', 'timeFrame': 'Measured after the implementation', 'description': 'Feasibility is the extent to which sign-out and documentation of iAEs can be successfully used or carried out within a given setting. It will be measured by the Feasibility of Intervention Measure FIM.'}, {'measure': 'Sustainment', 'timeFrame': '12 months after the last patient out', 'description': 'Sustainment is measured by comparing (full) adherence (defined as completeness of all ticks on the sign-out checklist) 12 months after implementation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perioperative safety', 'sign-out', 'intraoperative adverse events', 'ClassIntra®', 'hybrid design'], 'conditions': ['Perioperative Patient Safety']}, 'descriptionModule': {'briefSummary': "Intra- and postoperative adverse events (iAEs and pAEs) occur in up to one third of all patients undergoing surgery. They are devastating to patients and costly to health care systems. Their number tends to increase due to the rising complexity of both the patient's risk profile and the surgical procedure. Postoperative deaths have been identified to be the third most frequent cause of death worldwide. Teamwork in surgery has been attributed to have a potentially great impact on avoiding postoperative morbidity. Up to 50% of all adverse in-hospital events were rated to be potentially preventable. However, their prevention typically requires a change in systems and individual behaviour. Standardised assessments of iAEs and pAEs are a prerequisite to develop and define strategies for prevention of AEs. While awareness of pAEs has highly risen through the introduction of the Clavien-Dindo classification, the most widely used classification for grading severity of pAEs, the relevance of transparent monitoring of iAEs is still highly undervalued."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All in-hospital patients (consecutive) undergoing surgery in the operating room with anaesthesia involvement', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All in-hospital patients (consecutive or random sample) undergoing surgery from general surgery, vascular, surgery, orthopaedics/traumatology and urology in the operating room with anaesthesia involvement\n\nExclusion Criteria:\n\n* Patients undergoing one-day-surgery (with or without anaesthesia-involvement)\n* Procedures without anaesthesia-involvement (in- or out-patient)\n* ASA risk classification (ASA) VI patients (brain-death, organ-donor)\n* Follow-up procedure of a patient already included in the study'}, 'identificationModule': {'nctId': 'NCT05818332', 'acronym': 'CIBOSurg', 'briefTitle': 'ClassIntra® for Better Outcomes in Surgery - CIBOSurg', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Implementation of Routine Recording of Intraoperative Adverse Events According to ClassIntra® During the Sign-out Phase of the WHO Surgical Safety Checklist Using a Multifaceted, Tailored Implementation Strategy: Protocol of a Collaborative Before- and After-cohort Project', 'orgStudyIdInfo': {'id': 'Req-2023-00330'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'before and after implementation cohort', 'description': 'consecutive cohort of 900 surgical patients (baseline)\n\nconsecutive cohort of 900 surgical patients (after implementation with a multifaceted, tailored implementation strategy to improve adherence to the WHO SSC and routine recording of iAEs)', 'interventionNames': ['Other: Observational study']}], 'interventions': [{'name': 'Observational study', 'type': 'OTHER', 'description': 'No intervention, observational only', 'armGroupLabels': ['before and after implementation cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nijmegen', 'status': 'WITHDRAWN', 'country': 'Netherlands', 'facility': 'Radboud UMC', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Basel', 'status': 'COMPLETED', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'city': 'Bern', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Judith Winkens', 'role': 'CONTACT', 'email': 'judith.winkens@lindenhofgruppe.ch', 'phone': '+41 31 366 39 89'}], 'facility': 'Lindenhofspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Bern', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Andreas Vogt, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'andreas.vogt@insel.ch', 'phone': '+41 31 632 42 17'}], 'facility': 'University Hospital Berne', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Chur', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Gianluca Ursprung, Dipl. med.', 'role': 'CONTACT', 'email': 'gianluca.ursprung@ksgr.ch', 'phone': '+41 81 256 69 32'}], 'facility': 'Cantonal Hospital Graubünden', 'geoPoint': {'lat': 46.84986, 'lon': 9.53287}}, {'city': 'Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Guy Haller, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'guy.haller@huge.ch'}], 'facility': 'University Hospital Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'city': 'Lausanne', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Dieter Hahnloser, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'dieter.hahnloser@chuv.ch', 'phone': '+41 21 314 66 31'}], 'facility': 'University Hospital Lausanne', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'city': 'Lucerne', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Markus Gass, Dr. med.', 'role': 'CONTACT', 'email': 'markus.gass@luks.ch', 'phone': '+41 41 205 45 39'}], 'facility': 'Cantonal Hospital Lucerne', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}, {'city': 'Lugano', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Giorgio Prouse, Dr. med.', 'role': 'CONTACT', 'email': 'Giorgio.Prouse@eoc.ch', 'phone': '+41 91 811 66 03'}], 'facility': 'Regional Hospital Lugano', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}, {'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Valentin Neuhaus, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'valentin.neuhaus@usz.ch', 'phone': '+41 44 255 23 99'}], 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Salome Dell-Kuster, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'salome.dell-kuster@usb.ch', 'phone': '+41 61 328 64 74'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}