Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-05 @ 8:20 AM
Study NCT ID:
NCT03255356
Status:
UNKNOWN
Last Update Posted:
2017-08-21
First Post:
2017-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventilation in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-18', 'studyFirstSubmitDate': '2017-06-12', 'studyFirstSubmitQcDate': '2017-08-18', 'lastUpdatePostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of use prophylactic protective mechanical ventilation defined with with low tidal volume (6 to 8 ml / kg based on the ideal body weight)', 'timeFrame': '1 day', 'description': 'percent'}], 'secondaryOutcomes': [{'measure': 'incidence of using positive end-expiratory pressure', 'timeFrame': '1 day', 'description': '(PEEP)\\> 5 cmH2O'}, {'measure': 'incidence of using at least 2 alveolar lung recruitment manoeuvres', 'timeFrame': '1 day', 'description': 'percent'}, {'measure': 'incidence of using a protective ventilation bundle combining prophylactic protective mechanical ventilation and at least 2 alveolar recruitment manoeuvres', 'timeFrame': '1 day', 'description': 'percent'}, {'measure': 'incidence of postoperative pulmonary complications', 'timeFrame': '1 month postoperatively', 'description': 'percent'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative pulmonary complications', 'Protective mechanical ventilation', 'Alveolar lung recruitment manoeuvres', 'Cardiac Surgery Procedures'], 'conditions': ['Respiratory Complication', 'Respiration, Artificial', 'Anesthesia, General', 'Bypass, Cardiopulmonary']}, 'referencesModule': {'references': [{'pmid': '23902482', 'type': 'BACKGROUND', 'citation': 'Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.'}, {'pmid': '26643102', 'type': 'BACKGROUND', 'citation': 'Lellouche F, Delorme M, Bussieres J, Ouattara A. Perioperative ventilatory strategies in cardiac surgery. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):381-95. doi: 10.1016/j.bpa.2015.08.006. Epub 2015 Sep 4.'}, {'pmid': '26120769', 'type': 'BACKGROUND', 'citation': 'Guldner A, Kiss T, Serpa Neto A, Hemmes SN, Canet J, Spieth PM, Rocco PR, Schultz MJ, Pelosi P, Gama de Abreu M. Intraoperative protective mechanical ventilation for prevention of postoperative pulmonary complications: a comprehensive review of the role of tidal volume, positive end-expiratory pressure, and lung recruitment maneuvers. Anesthesiology. 2015 Sep;123(3):692-713. doi: 10.1097/ALN.0000000000000754.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate prospectively ventilatory practices in the perioperative cardiac surgery period.', 'detailedDescription': 'This is a International Multicentre Observational Trial on all adult cardiac surgery patients with cardiopulmonary bypass (CPB).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All adult cardiac surgery patients with cardiopulmonary bypass (CPB).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive cardiac surgery patients with CPB during one predefined period,\n* Elective or urgent surgery as defined by EuroSCORE2.\n\nExclusion Criteria:\n\n* Refusal of consent,\n* Pregnant women,\n* Age \\< 18 years,\n* Heart transplant, ECLS, ventricular assist\n* Emergency or salvage surgery as defined by EuroSCORE2'}, 'identificationModule': {'nctId': 'NCT03255356', 'acronym': 'VENICE', 'briefTitle': 'Ventilation in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'International Multicentre Observational Trial of Perioperative Ventilatory Management in Cardiac Surgery', 'orgStudyIdInfo': {'id': '16-081'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort', 'description': 'An anonymised questionnaire will be answered for each includable consecutive patient after verifying the absence of exclusion criteria.', 'interventionNames': ['Other: Survey']}], 'interventions': [{'name': 'Survey', 'type': 'OTHER', 'otherNames': ['not adapted'], 'description': 'An anonymised questionnaire will be answered for each includable consecutive patient after verifying the absence of exclusion criteria.', 'armGroupLabels': ['Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'contacts': [{'name': 'Alexandre Joosten, MD', 'role': 'CONTACT', 'email': 'joosten-alexandre@hotmail.com'}], 'facility': 'CUB Erasm, Université libre de Bruxelles', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Brasil', 'country': 'Brazil', 'contacts': [{'name': 'Caetano Nigro Neto, MD', 'role': 'CONTACT', 'email': 'caenigro@uol.com.br'}], 'facility': 'Universidade Federal de São Paulo (UNIFESP)', 'geoPoint': {'lat': -21.58333, 'lon': -46.9}}, {'city': 'Prague', 'country': 'Czechia', 'contacts': [{'name': 'Jan Kunstyr, MD', 'role': 'CONTACT', 'email': 'jkunstyr@gmail.com'}], 'facility': 'General University Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '14 000', 'city': 'Caen', 'country': 'France', 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '07747', 'city': 'Jena', 'country': 'Germany', 'contacts': [{'name': 'Christoph Sponholz, MD', 'role': 'CONTACT', 'email': 'christoph.sponholz@med.uni-jena.de'}], 'facility': 'Klinik für Anästhesiologie und Intensivmedizin', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'Pisa', 'country': 'Italy', 'contacts': [{'name': 'Fabio Guarracino, MD', 'role': 'CONTACT', 'email': 'f.guarracino@ao-pisa.toscana.it'}], 'facility': 'Azienda Ospedaliera Universitaria', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '545-8586', 'city': 'Ōsaki', 'country': 'Japan', 'contacts': [{'name': 'Koichi Koichi, MD', 'role': 'CONTACT', 'email': 'suehirokoichi@yahoo.co.jp'}], 'facility': 'Osaka city University Graduate school of Medecine', 'geoPoint': {'lat': 38.58866, 'lon': 140.973}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VU University Hospital', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Trondheim', 'country': 'Norway', 'contacts': [{'name': 'Idar KIRKEBY-GARSTAD', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'idar.kirkeby-garstad@ntnu.no'}], 'facility': 'St Olav University Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'city': 'Wroclaw', 'country': 'Poland', 'contacts': [{'name': 'Waldemar Gozdzik, MD', 'role': 'CONTACT', 'email': 'waldemar.gozdzik@gmail.com'}], 'facility': 'Wroclaw Medical University', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'centralContacts': [{'name': 'Marc-Olivier Fischer, MD, PhD', 'role': 'CONTACT', 'email': 'fischer-mo@chu-caen.fr', 'phone': '+33 2 31 06 31 06'}, {'name': 'Jennifer Brunet, MD', 'role': 'CONTACT', 'email': 'brunet-j@chu-caen.fr', 'phone': '33 2 31 06 31 06'}], 'overallOfficials': [{'name': 'Marc-Olivier Fischer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Caen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}