Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-01-02 @ 12:15 AM
Study NCT ID:
NCT06486168
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2024-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Diaphragmatic Dysfunction After Non-Intubated Video-Assisted Thoracoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2024-06-21', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diaphragmatic excursion', 'timeFrame': 'Hour 24', 'description': "The measurement of diaphragmatic excursion at H2 and H24 constitutes the primary evaluation criterion. Diaphragmatic excursion will be measured by ultrasound using a low-frequency probe (\\< 5 MHz), either an abdominal or cardiac probe, positioned under the costal margin on the operated side and the contralateral side. To limit inter-operator variability, the patient's ultrasound evaluation will, as much as possible, be performed by the same operator. The presence of diaphragmatic dysfunction is defined by a diaphragmatic excursion of less than 1 cm."}], 'secondaryOutcomes': [{'measure': 'Pain evaluation', 'timeFrame': 'Hour 2', 'description': 'Pain will be assessed using a simple numeric scale ranging from 0 (no pain) to 10 (worst pain ever experienced).'}, {'measure': 'Pain evaluation', 'timeFrame': 'Hour 24', 'description': 'Pain will be assessed using a simple numeric scale ranging from 0 (no pain) to 10 (worst pain ever experienced).'}, {'measure': 'Diaphragmatic thickening evaluation', 'timeFrame': 'Hour 2', 'description': 'Diaphragmatic thickening will be measured by ultrasound and will be assessed in relation to the baseline thickness and the contralateral diaphragmatic thickness'}, {'measure': 'Diaphragmatic thickening evaluation', 'timeFrame': 'Hour 24', 'description': 'Diaphragmatic thickening will be measured by ultrasound and will be assessed in relation to the baseline thickness and the contralateral diaphragmatic thickness'}, {'measure': 'postoperative complications evaluation', 'timeFrame': 'Hour 2', 'description': 'The screening for hypoxemia using a pulse oximeter will be conducted continuously throughout the study duration.\n\nCardiovascular events will be evaluated based on the time to the occurrence of one of the 3 major cardiac events comprising the composite endpoint MACE (Major Adverse Cardiac Events): cardiovascular death, non-fatal myocardial infarction, non-fatal stroke.'}, {'measure': 'postoperative complications evaluation', 'timeFrame': 'Hour 24', 'description': 'The screening for hypoxemia using a pulse oximeter will be conducted continuously throughout the study duration.\n\nCardiovascular events will be evaluated based on the time to the occurrence of one of the 3 major cardiac events comprising the composite endpoint MACE (Major Adverse Cardiac Events): cardiovascular death, non-fatal myocardial infarction, non-fatal stroke.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diaphragmatic Dysfunction']}, 'descriptionModule': {'briefSummary': 'The objective of this this single-center prospective longitudinal study is to evaluate the incidence of diaphragmatic dysfunction after non-intubated video-assisted thoracoscopic surgery (NIVATS).\n\nParticipant will be evaluated during surgery, 2 hours and 24 hours after surgery.', 'detailedDescription': 'This is a prospective longitudinal single-center study conducted on patients undergoing non-intubated video-assisted thoracoscopic surgery. The main indications for this surgery are wedge resections, pneumothorax repair, and pleural biopsies (with or without talc pleurodesis) for pleural effusion.\n\nExcept for the inclusion visit, each patient will be evaluated twice, 2 and 24 hours after the end of the surgical procedure. The data from each evaluation will be recorded by the physician in the electronic CRF'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged 18 years or older\n* Patient who has read and signed the informed consent form for participation in the study\n* Patient undergoing surgery with video-assisted thoracoscopic surgery without intubation\n\nExclusion Criteria:\n\n* Known or detected diaphragmatic dysfunction before the intervention\n* Patient not affiliated with the French social security system\n* Patient under legal protection, guardianship, or curatorship\n* Patient already enrolled in another therapeutic study protocol (involving medications or non-drug therapies)\n* Patient in an exclusion period from a previous clinical study\n* Mental deficiency or any other reason that may hinder understanding or strict adherence to the protocol'}, 'identificationModule': {'nctId': 'NCT06486168', 'acronym': 'DYNASTY', 'briefTitle': 'Incidence of Diaphragmatic Dysfunction After Non-Intubated Video-Assisted Thoracoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': "GCS Ramsay Santé pour l'Enseignement et la Recherche"}, 'officialTitle': 'Incidence of Diaphragmatic Dysfunction After Non-Intubated Video-Assisted Thoracoscopic Surgery.', 'orgStudyIdInfo': {'id': '2024-A00912-45'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diaphragmatic Dysfunction evaluation', 'interventionNames': ['Procedure: NIVATS']}], 'interventions': [{'name': 'NIVATS', 'type': 'PROCEDURE', 'description': 'Non-Intubated Video-Assisted Thoracic Surgery (NIVATS) is the least invasive approach available. It is part of an optimal Enhanced Recovery After Surgery (ERAS) pathway and allows for expanding surgical indications in patients with poor cardio-pulmonary function.', 'armGroupLabels': ['Diaphragmatic Dysfunction evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91480', 'city': 'Quincy-sous-Sénart', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nabil ZANOUN, MD', 'role': 'CONTACT', 'email': 'nabil.zanoun@yahoo.fr', 'phone': '01 69 39 15 53', 'phoneExt': '33'}, {'name': 'Karim GUESSOUS, MD', 'role': 'CONTACT', 'email': 'guess_02@hotmail.fr'}], 'facility': 'Hôpital Privé Claude Galien', 'geoPoint': {'lat': 48.67294, 'lon': 2.53419}}], 'centralContacts': [{'name': 'Nabil ZANOUN, MD', 'role': 'CONTACT', 'email': 'nabil.zanoun@yahoo.fr', 'phone': '01 69 39 15 53', 'phoneExt': '33'}, {'name': 'Karim GUESSOUS, MD', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ICF'], 'ipdSharing': 'YES', 'description': 'Only data strictly relevant to and directly used in the published article will be eligible for sharing. No data outside the scope of the published analysis will be provided.', 'accessCriteria': 'Data may be made available upon explicit request from the journal and solely for the purpose of conducting a re-analysis of the published results. Requests must be submitted by email to the corresponding author. The statistical code used for the original analyses may also be shared if necessary. The study authors may be invited to participate in the re-analysis depending on the nature of the request.\n\nData will be provided as an anonymized Excel file, in compliance with applicable personal data protection regulations. No information allowing direct or indirect identification of study participants will be disclosed.\n\nShared data may be used only for the purpose defined in the initial request. No secondary use, data transfer agreement, or further data exploitation will be authorized.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "GCS Ramsay Santé pour l'Enseignement et la Recherche", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}