Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT04793802
Status:
COMPLETED
Last Update Posted:
2022-05-13
First Post:
2020-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Physiotherapy Session in Cardiac Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-11', 'studyFirstSubmitDate': '2020-12-04', 'studyFirstSubmitQcDate': '2021-03-09', 'lastUpdatePostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung ultrasound score', 'timeFrame': 'The time of the event (the 2 measurements + the physiotherapy session) is estimated at 45 minutes.', 'description': "Reliable and verified score, subject to international recommendations allowing the physiotherapist to deepen his diagnosis and evaluate the effectiveness of his techniques. Measured on 12 thoracic regions The score (N B1 B2 C) will therefore be calculated according to the level obtained in each zone to determine a score out of 36. The higher the score, the more the lung has a deficit of ventilation.\n\nA decrease in the objective lung ultrasound score will result in better lung aeration.\n\nTwo lung ultrasound score measurements are realized on one patient. The first measurement is taken on the day of inclusion of the patient in the study at the time of the physiotherapist's assessment before the CPT session. (CPT = Chest Physiotherapy Treatment) The second and last measurement is taken after the CPT session (with or without NIV, depending on the medical prescription)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physiotherapy', 'Cardiac surgery', 'Lung ultrasound score', 'Noninvasive ventilation', 'High flow oxygenation'], 'conditions': ['Physical Therapy in Cardiac Surgery Patients']}, 'descriptionModule': {'briefSummary': 'This work consists, first of all, in making an inventory of the physiotherapy of the patient undergoing cardiac surgery under high flow oxygenation at the CHRU NANCY.\n\nThen, in a second step, the impact of the physiotherapy on the lung ultrasound score associated or not with the NIV of the patient under OHD after cardiac surgery will be studied.\n\nThe objective is therefore to answer the following research question: what is the impact of a physiotherapy session with or without non-invasive ventilation in patients receiving high flow oxygenation after cardiac surgery on the lung ultrasound score measured by ultrasound?\n\nMain hypothesis: Physiotherapy is associated with NIV when it is prescribed in patients undergoing high flow oxygenation after cardiac surgery.\n\nSecondary hypothesis: Physiotherapy + NIV further improves pulmonary aeration versus physiotherapy + high flow oxygenation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The subjects of the study will be patients who stayed in the Cardiovascular Surgery and Cardiac Transplant Intensive Care Unit at NANCY CHRU from September 15, 2020 to March 15, 2021', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person who has received full information on the organization of the research and has not objected to the use of the data.\n* Person benefiting from cardiac surgery programmed on Cardiothoracic Bypass\n* Patient under high flow oxygenation\n* Age ≥ 18 years old\n* 18.5 ≤ BMI ≤ 35 kg/m2\n* Conscious and oriented patients: Glasgow 15\n\nExclusion Criteria:\n\n* Surgical emergencies: grafting, dissections...\n* Lumbar drainage in progress\n* Beating heart surgery\n* Refusal to participate in the study\n* Persons referred to in Articles L.1121-8 and L.1122-1-2 of the Public Health Code (minors, person under guardianship, under curatorship)'}, 'identificationModule': {'nctId': 'NCT04793802', 'briefTitle': 'Impact of Physiotherapy Session in Cardiac Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Impact of Physiotherapy Session With or Without Non Invasive Ventilation in the Patient Benefiting From High Nasal Flow Oxygenation After Cardiac Surgery: a Pilot Study', 'orgStudyIdInfo': {'id': '2020PI208'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients benefiting from HIGH-FLOW OXYGENATION + NONINVASIVE VENTILATION', 'description': 'Patients benefiting from high-flow oxygenation will have their physiotherapy session with non-invasive ventilation.', 'interventionNames': ['Other: PHYSIO']}, {'label': 'Patients benefiting from HIGH-FLOW OXYGENATION', 'description': 'Patients benefiting from high-flow oxygenation will have their physiotherapy session without non-invasive ventilation.', 'interventionNames': ['Other: PHYSIO']}], 'interventions': [{'name': 'PHYSIO', 'type': 'OTHER', 'description': 'session of physiotherapy', 'armGroupLabels': ['Patients benefiting from HIGH-FLOW OXYGENATION', 'Patients benefiting from HIGH-FLOW OXYGENATION + NONINVASIVE VENTILATION']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'CHRU nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Jean PAYSANT, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Hospital, Nancy, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor, Medical Doctor, Philosophiae Doctor', 'investigatorFullName': 'PAYSANT Jean', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}