Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-25 @ 2:50 PM
Study NCT ID:
NCT06153550
Status:
COMPLETED
Last Update Posted:
2023-12-13
First Post:
2023-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Benefit of Preparation in Respiratory Physiotherapy Before a Sternotomy in the Context of Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-12', 'studyFirstSubmitDate': '2023-11-23', 'studyFirstSubmitQcDate': '2023-11-30', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of the evolution of the pulmonary function by Forced spirometry.', 'timeFrame': '3 weeks before, the day before and the day after surgery.', 'description': 'Measured by spirometry and pulse oximetry results.'}], 'secondaryOutcomes': [{'measure': 'Analysis of the evolution of the pulmonary function by Resistance', 'timeFrame': '3 weeks before, the day before and the day after surgery.', 'description': 'Measured by spirometry and pulse oximetry results.'}, {'measure': 'Analysis of the evolution of the pulmonary function by Lung volumes', 'timeFrame': '3 weeks before, the day before and the day after surgery.', 'description': 'Measured by spirometry and pulse oximetry results.'}, {'measure': 'Analysis of the evolution of the pulmonary function by Dissemination capacity,', 'timeFrame': '3 weeks before, the day before and the day after surgery.', 'description': 'Measured by spirometry and pulse oximetry results.'}, {'measure': 'Analysis of the evolution of the pulmonary function by Flow / volume curves', 'timeFrame': '3 weeks before, the day before and the day after surgery.', 'description': 'Measured by spirometry and pulse oximetry results.'}, {'measure': 'Analysis of the evolution of the pulmonary function by Peripheral saturation', 'timeFrame': '3 weeks before, the day before and the day after surgery.', 'description': 'Measured by spirometry and pulse oximetry results.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac surgery', 'Sternotomy', 'respiration', 'Spirometry', 'pulse oximetry'], 'conditions': ['Sternotomy']}, 'descriptionModule': {'briefSummary': 'The sternotomy has some influence on the respiratory system after cardiac surgery, considerably increasing the risk of perioperative and postoperative breathing.\n\nThere is respiratory preparation before cardiac surgery using local physiotherapeutic guidelines.', 'detailedDescription': 'The aim of the study is to have a quantification of this preparation spirometry: before starting the preparation and at the end of the preparation (right before surgery) by comparing the spirometric and pulse oximetry information. The prospective study will be conducted on 25 patients, who will be selected consecutively without randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with indication of cardiac surgery will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with indication of cardiac surgery\n\nExclusion Criteria:\n\n* Patient with a Body Mass Index (BMI) \\> 30\n* Restrictive patient\n* Obstructive patient\n* Asthmatic\n* Chronic Obstructive Pulmonary Disease (COPD)\n* History of pulmonary fibrosis, tuberculosis\n* Coronary patients with stenosis of the common trunk.\n* Emergency and lifesaving surgeries\n* History of thoracic trauma\n* Severe kyphotic patients\n* History of radiotherapy\n* Patients with neuromuscular disease\n* Patients with thoracic cage involvement (pectus excavatum, post thoracic surgery)\n* Patients with emphysema\n* Patients with dilated bronchi'}, 'identificationModule': {'nctId': 'NCT06153550', 'briefTitle': 'The Benefit of Preparation in Respiratory Physiotherapy Before a Sternotomy in the Context of Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'The Benefit of Preparation in Respiratory Physiotherapy Before a Sternotomy in the Context of Cardiac Surgery', 'orgStudyIdInfo': {'id': 'IRBN522021/CHUSTE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who have sternotomy', 'description': 'Patients who have sternotomy wll be included. They will have preparation in Respiratory Physiotherapy before sternotomy.', 'interventionNames': ['Other: preparation in Respiratory Physiotherapy']}], 'interventions': [{'name': 'preparation in Respiratory Physiotherapy', 'type': 'OTHER', 'description': 'preparation in Respiratory Physiotherapy consist to:\n\n* 3 sessions per week with the physiotherapist\n* spirometry and pulse oximetry test 3 weeks before surgery, the day before surgery and the day after surgery.', 'armGroupLabels': ['Patients who have sternotomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Andranik PETROSYAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}