Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-01-01 @ 7:39 PM
Study NCT ID:
NCT03978169
Status:
UNKNOWN
Last Update Posted:
2019-06-07
First Post:
2019-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Impacts of Anaesthetic Modalities Evaluated by Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 99}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-05', 'studyFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2019-06-05', 'lastUpdatePostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lung lesions by the anaesthetic and operative management after knee replacement surgery', 'timeFrame': '10 minutes before surgery', 'description': 'Describe lung lesions by the anaesthetic and operative management after knee replacement surgery'}, {'measure': 'lung lesions by the anaesthetic and operative management after knee replacement surgery', 'timeFrame': '10 minutes post surgery', 'description': 'Describe lung lesions by the anaesthetic and operative management after knee replacement surgery'}, {'measure': 'lung lesions by the anaesthetic and operative management after knee replacement surgery', 'timeFrame': '24hours post surgery', 'description': 'Describe lung lesions by the anaesthetic and operative management after knee replacement surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anaesthetic modality', 'Lung'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'A prospective, observational, monocentric study aimed at identifying ultrasound changes in anaesthesia on the pulmonary parenchyma after knee arthroplastic surgery using the LUS score in the preoperative, immediate post-operative (D0) and late post-operative (D1) periods.', 'detailedDescription': 'Post-operative pulmonary complications are responsible from morbidity and mortality close to cardiovascular complications.\n\nPerioperative and post-operative respiratory changes are secondary to anaesthesia (general anaesthesia, elongated position, tidal volume) and to surgery in particular abdominal and cardiothoracic surgery.\n\nSeveral risk factors related to patients were identified: age, ASA score\\> 2, functional dependence, chronic obstructive pulmonary disease, congestive heart failure, obesity, smoking.\n\nPulmonary ultrasound is a simple and rapid means of monitoring, widely used in resuscitation and developing in anaesthesia.\n\nThe hypothesis of the study is that anaesthesia and / or ventilation is responsible for lung lesions observable by ultrasound from the recovery room, even after extra-thoracic surgeries.\n\nTo do this, it will perform 3 pleuro-pulmonary ultrasound scans, preoperatively on the day of surgery, post-operatively in the recovery room and the day after surgery. LUS score will be calculated. Preoperative data (morphology, comorbidities), preoperative (ventilation, filling, position, type of anaesthesia - general anaesthesia with intubation or laryngeal mask, spinal anaesthesia- , type of surgery) and postoperative data (constants, oxygen therapy, complications) will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient undergoing scheduled primary knee arthroplasty', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient undergoing scheduled primary knee arthroplasty :\n* Partial knee replacement surgery\n* Total knee replacement surgery\n\n • Type of Anaesthesia\n* General anaesthesia with orotracheal intubation\n* General anaesthesia with laryngeal mask\n* Spinal anaesthesia\n\n * Major Patient\n * Oral non opposition collected after oral information of the study\n\nExclusion Criteria:\n\n* Refusal to participate\n* Preoperative pleural pathology (pleural effusion, pleural symphysis)\n* Pregnancy\n* Patient under authorship or curators\n* non-affiliation to a social security scheme'}, 'identificationModule': {'nctId': 'NCT03978169', 'acronym': 'PULCHO-KNEE', 'briefTitle': 'Pulmonary Impacts of Anaesthetic Modalities Evaluated by Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Pulmonary Impacts of Anaesthetic Modalities Evaluated by Ultrasound: A Prospective Study in Scheduled Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'RC31/18/0379'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General anaesthesia with orotracheal intubation', 'description': 'surgery patients under general anaesthesia with orotracheal intubation', 'interventionNames': ['Diagnostic Test: pleuropulmonary ultrasound']}, {'label': 'General anaesthesia with laryngeal mask', 'description': 'surgery patient under general anaesthesia with laryngeal mask', 'interventionNames': ['Diagnostic Test: pleuropulmonary ultrasound']}, {'label': 'Spinal anaesthesia', 'description': "surgery's patients under Spinal anaesthesia", 'interventionNames': ['Diagnostic Test: pleuropulmonary ultrasound']}], 'interventions': [{'name': 'pleuropulmonary ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'three pleuro-pulmonary ultrasound scans will be performed, preoperatively on the day of surgery, post-operatively in the recovery room and the day after surgery', 'armGroupLabels': ['General anaesthesia with laryngeal mask', 'General anaesthesia with orotracheal intubation', 'Spinal anaesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabrice FERRE, MD', 'role': 'CONTACT', 'email': 'ferre.f@chu-toulouse.fr', 'phone': '05 61 77 99 88', 'phoneExt': '+33'}, {'name': 'Fabrice FERRE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Laeticia BOSCH, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UHToulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Fabrice FERRE, MD', 'role': 'CONTACT', 'email': 'ferre.f@chu-toulouse.fr', 'phone': '05 61 77 99 88', 'phoneExt': '+33'}, {'name': 'LAETITIA BOSCH, MD', 'role': 'CONTACT', 'email': 'bosch.l@chu-toulouse.fr', 'phone': '05 61 77 99 80', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Fabrice FERRE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}