Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-26 @ 12:50 AM
Study NCT ID:
NCT05545566
Status:
COMPLETED
Last Update Posted:
2023-03-16
First Post:
2022-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Thoracic Ultrasound in Monitoring Pleural Drainage in Postoperative Thoracic 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': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-15', 'studyFirstSubmitDate': '2022-09-10', 'studyFirstSubmitQcDate': '2022-09-14', 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Theoretical patient discharge', 'timeFrame': 'At the study completion, an average of 10 days', 'description': 'Theoretical patient discharge based on imaging data (pleural ultrasound or chest x-ray):\n\n* YES: Score ≤ 2 on each of the 4 items assessed AND total score ≤ 4.\n* NO: Score ≥ 3 on each of the items assessed and/or total score ≥ 5.'}], 'secondaryOutcomes': [{'measure': 'Pain du to examination', 'timeFrame': 'Day 0, Day 1 and At the study completion, an average of 10 days', 'description': 'To compare the pain generated by each examination (thoracic radiography and pleural ultrasound) with Visual Analogic Scale (0 to 10) at Day 0, Day 1 and post-drainage)'}, {'measure': 'Subcutaneous emphysema', 'timeFrame': 'Day 0, Day 1 and At the study completion, an average of 10 days', 'description': 'Evaluation of the concordance of pleural ultrasound data and chest radiography on the presence of subcutaneous emphysema at D0, D1 and post drain removal.'}, {'measure': 'Pneumothorax', 'timeFrame': 'Day 0, Day 1 and At the study completion, an average of 10 days', 'description': 'Evaluation of the concordance of pleural ultrasound data and chest radiography on the presence of Pneumothorax at D0, D1 and post drain removal.'}, {'measure': 'Pleural effusion', 'timeFrame': 'Day 0, Day 1 and At the study completion, an average of 10 days', 'description': 'Evaluation of the concordance of pleural ultrasound data and chest radiography on the presence of Pleural effusion at D0, D1 and post drain removal.'}, {'measure': 'Pulmonary Condensation', 'timeFrame': 'Day 0, Day 1 and At the study completion, an average of 10 days', 'description': 'Evaluation of the concordance of pleural ultrasound data and chest radiography on the presence of Pulmonary Condensation at D0, D1 and post drain removal.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative thoracic surgery', 'discharge decision', 'thoracic ultrasound', 'pleural drain removal', 'chest X-ray', 'thoracic surgery monitoring'], 'conditions': ['Thoracic Ultrasound', 'Pleural Drain Removal']}, 'descriptionModule': {'briefSummary': 'The investigator would like to conduct a study in patients undergoing thoracic surgery to evaluate the effectiveness of thoracic ultrasound in the decision to discharge the patient after pleural drain removal.', 'detailedDescription': 'Thoracic drainage is a common and almost systematic practice after thoracic surgery requiring daily management and monitoring until and after its removal.\n\nIt allows, after opening the pleura, the evacuation of liquid and/or air retained in the pleural cavity.\n\nThe overall monitoring of the patient after thoracic surgery is based on clinical vigilance combined with thoracic imaging, in particular the chest X-ray which remains the Gold Standard (reference examination).\n\nThe removal of the drain is decided according to the quantity and appearance of the evacuated fluid, the persistence of air leaks, etc… A few hours after the removal of the drain, it is routine to perform a chest X-ray before authorizing a possible discharge from the department.\n\nThis practice does not correspond to an established scientific protocol but is systematically performed in our department before discharge.\n\nSeveral studies have defended the place of ultrasound in thoracic imaging and its contribution to the detection of postoperative and intensive care complications.\n\nUnlike radiography, this technique is non-irradiating, less expensive and more readily available. It allows the detection of pneumothorax, pleural effusions and other complications detectable on X-ray.\n\nTo our knowledge, the contribution of thoracic ultrasound has not been studied in the decision to authorize the discharge of the patient after removal of the thoracic drain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients undergoing thoracic surgery (lung resection, pleural symphysis, biopsy or resection of a mediastinal tumor or ganglion, pleural decortication/decalcification) admitted immediately after surgery in the thoracic surgery department (standard care or continuous care) of the University Hospital of Limoges.\n\nExclusion Criteria:\n\n* Admission to the intensive care unit after thoracic surgery.\n* Pneumonectomy\n* Chest wall surgery\n* Patients \\<18 years old\n* Not affiliated to social security\n* Under guardianship or curatorship\n* Pregnant women\n* Not knowing the French language'}, 'identificationModule': {'nctId': 'NCT05545566', 'acronym': 'EchTHor', 'briefTitle': 'Evaluation of Thoracic Ultrasound in Monitoring Pleural Drainage in Postoperative Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'Evaluation of Thoracic Ultrasound in Monitoring Pleural Drainage in Postoperative Thoracic Surgery', 'orgStudyIdInfo': {'id': '87RI22_0022 (EchTHor)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All patients', 'interventionNames': ['Procedure: Thoracic ultrasound versus chest X-ray']}], 'interventions': [{'name': 'Thoracic ultrasound versus chest X-ray', 'type': 'PROCEDURE', 'description': 'Perform un ultrasound test, in addition to Chest X-Ray (usual practice), few hours after the surgery (D0), the next day (D1) and 4 to 6 hours after drain removal.\n\nThe data are collected in the standardized protocol for the two type of imaging.\n\nThe thoracic ultrasound and the Chest X-Ray are performed, blindly each other, in the same position for the patient and the same suction level of drain.', 'armGroupLabels': ['All patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Limoges Univesity Hospital', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}