Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
Study NCT ID:
NCT05532033
Status:
COMPLETED
Last Update Posted:
2023-10-24
First Post:
2022-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Flow Nasal Cannula and Diaphragmatic Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-22', 'studyFirstSubmitDate': '2022-08-09', 'studyFirstSubmitQcDate': '2022-09-07', 'lastUpdatePostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Days without oxygen support', 'timeFrame': '7 days'}], 'primaryOutcomes': [{'measure': 'Incidence of diaphragmatic dysfunction', 'timeFrame': '24 hours after surgery', 'description': 'Ultrasound evaluation of diaphragmatic dysfunction'}], 'secondaryOutcomes': [{'measure': 'Postoperative pulmonary complication', 'timeFrame': '7 days after surgery', 'description': 'Incidence of postoperative pulmonary complication'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diaphragm Injury', 'Postoperative Complications']}, 'referencesModule': {'references': [{'pmid': '40706477', 'type': 'DERIVED', 'citation': 'Fogagnolo A, Grasso S, Dres M, Azzolina D, Dalla Corte F, Dolci G, Tamburini N, De Paoli G, Murgolo F, Pedarzani E, Andalo A, Volta CA, Savino S. Impact of early high flow nasal oxygen on diaphragmatic function and pulmonary complications after thoracic surgery: A randomized clinical trial. J Clin Anesth. 2025 Sep;106:111945. doi: 10.1016/j.jclinane.2025.111945. Epub 2025 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'Prospective randomized study investigating the effect of postoperative oxygen delivery on diaphragmatic function. Two different modalities of oxygen delivery will be compared: high flow nasal cannula versus standard oxygen therapy with facial mask'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective thoracic surgery\n\nExclusion Criteria:\n\n* ASA score \\>3\n* Body mass index \\> 35 kg/m2\n* History of neuromuscular disease\n* History of thoracic surgery\n* Phrenic nerve paisy'}, 'identificationModule': {'nctId': 'NCT05532033', 'briefTitle': 'High Flow Nasal Cannula and Diaphragmatic Function', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Ferrara'}, 'officialTitle': 'Effect of High Flow Nasal Cannula vs Standard Oxygen Therapy on Diaphragmatic Function After Thoracic Surgery', 'orgStudyIdInfo': {'id': 'HFNCThoracic'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high flow nasal cannula', 'description': 'Two hours after extubation patients will received high flow nasal cannula oxygenation therapy for 24 hours', 'interventionNames': ['Device: High flow nasal cannula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard oxygen therapy', 'description': 'Two hours after extubation patients will received standard oxygenation therapy for 24 hours', 'interventionNames': ['Device: Facial mask']}], 'interventions': [{'name': 'High flow nasal cannula', 'type': 'DEVICE', 'description': 'A device able to delivery high flow oxygen therapy', 'armGroupLabels': ['high flow nasal cannula']}, {'name': 'Facial mask', 'type': 'DEVICE', 'description': 'standard oxygen therapy', 'armGroupLabels': ['Standard oxygen therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44121', 'city': 'Ferrara', 'country': 'Italy', 'facility': 'Università di Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'Study dataset will be shared in anonymous form under reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università degli Studi di Ferrara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Alberto Fogagnolo', 'investigatorAffiliation': 'Università degli Studi di Ferrara'}}}}