Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT06456606
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2024-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiopulmonary Effects of Prone Position in CARDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018497', 'term': 'Ventricular Dysfunction, Right'}], 'ancestors': [{'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-07', 'studyFirstSubmitDate': '2024-05-31', 'studyFirstSubmitQcDate': '2024-06-07', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA) change during prone position.', 'timeFrame': 'It was evaluated with transesophageal echocardiography three times: before prone position (T0), the first hour of prone position (T1), and the first hour of returning to the supine position (T0 + 24 hours) (T2) after 23 hours prone position treatment', 'description': 'It was preferred right ventricular recovery evaluation.'}], 'secondaryOutcomes': [{'measure': 'Static compliance (C-stat) change with prone position', 'timeFrame': 'It was evaluated with transesophageal echocardiography three times: before prone position (T0), the first hour of prone position (T1), and the first hour of returning to the supine position (T0 + 24 hours) (T2) after 23 hours prone position treatment', 'description': 'It was examined in the evaluation of the pulmonary effect of prone position as secondary outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transesophageal echocardiography', 'cards', 'heart lung interactions', 'prone position', 'right ventricle'], 'conditions': ['ARDS Due to Disease Caused by SARS Co-V-2', 'Right Ventricular Dysfunction']}, 'referencesModule': {'references': [{'pmid': '35200194', 'type': 'BACKGROUND', 'citation': 'Fossali T, Pavlovsky B, Ottolina D, Colombo R, Basile MC, Castelli A, Rech R, Borghi B, Ianniello A, Flor N, Spinelli E, Catena E, Mauri T. Effects of Prone Position on Lung Recruitment and Ventilation-Perfusion Matching in Patients With COVID-19 Acute Respiratory Distress Syndrome: A Combined CT Scan/Electrical Impedance Tomography Study. Crit Care Med. 2022 May 1;50(5):723-732. doi: 10.1097/CCM.0000000000005450. Epub 2022 Apr 11.'}, {'pmid': '32844261', 'type': 'RESULT', 'citation': 'Evrard B, Goudelin M, Fedou AL, Vignon P. Hemodynamic response to prone ventilation in COVID-19 patients assessed with 3D transesophageal echocardiography. Intensive Care Med. 2020 Nov;46(11):2099-2101. doi: 10.1007/s00134-020-06217-w. Epub 2020 Aug 26. No abstract available.'}, {'pmid': '35566751', 'type': 'RESULT', 'citation': 'Beyls C, Daumin C, Hermida A, Booz T, Ghesquieres T, Crombet M, Martin N, Huette P, Jounieaux V, Dupont H, Abou-Arab O, Mahjoub Y. Association between the Right Ventricular Longitudinal Shortening Fraction and Mortality in Acute Respiratory Distress Syndrome Related to COVID-19 Infection: A Prospective Study. J Clin Med. 2022 May 6;11(9):2625. doi: 10.3390/jcm11092625.'}, {'pmid': '35036925', 'type': 'RESULT', 'citation': 'Temperikidis P, Koroneos A, Xourgia E, Kotanidou A, Siempos II. Abnormal Right Ventricular Free Wall Strain Prior to Prone Ventilation May Be Associated With Worse Outcome of Patients With COVID-19-Associated Acute Respiratory Distress Syndrome. Crit Care Explor. 2022 Jan 11;4(1):e0620. doi: 10.1097/CCE.0000000000000620. eCollection 2022 Jan.'}, {'pmid': '34572414', 'type': 'RESULT', 'citation': "Tonetti T, Grasselli G, Rucci P, Alessandri F, Dell'Olio A, Boscolo A, Pasin L, Sella N, Mega C, Melotti RM, Girardis M, Busani S, Bellani G, Foti G, Grieco DL, Scaravilli V, Protti A, Langer T, Mascia L, Pugliese F, Cecconi M, Fumagalli R, Nava S, Antonelli M, Slutsky AS, Navalesi P, Pesenti A, Ranieri VM. Synergistic Effect of Static Compliance and D-dimers to Predict Outcome of Patients with COVID-19-ARDS: A Prospective Multicenter Study. Biomedicines. 2021 Sep 15;9(9):1228. doi: 10.3390/biomedicines9091228."}]}, 'descriptionModule': {'briefSummary': 'In coronavirus disease-2019 (COVID-19)-related ARDS (C-ARDS), especially in the severe form, increased shunt rate, impaired ventilation/perfusion ratio (V/Q), hypoxic pulmonary vasoconstriction inhibition, and increased immune microthrombosis may have similar effects on the right ventricle .The cardiopulmonary pathophysiology and outcomes of C-ARDS vary, and this variability requires monitoring to follow the diagnosis and treatment process. This study aimed to increase the treatment success of the prone position in C-ARDS and to provide a prognostic factor for survival by analyzing and monitoring heart-lung interactions. Therefore, we used transesophageal echocardiography (TEE) to evaluate the cardiopulmonary effects of prone position.', 'detailedDescription': 'This prospective study included 30 moderate-to-severe C-ARDS patients who were treated with prone position in the first 48 hours of invasive mechanical ventilation support. It was evaluated with transesophageal echocardiography three times: before prone position (PP) (T0), the first hour of PP (T1), and the first hour of returning to the supine position (T0 + 24 hours) (T2) after 23 hours prone position treatment. Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA) was preferred right ventricular evaluations as primer outcome. Static compliance (C-stat) was examined in the evaluation of the pulmonary effect of prone position as secondary outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'moderate/severe C-ARDS patients admitted to the Bakırköy Dr Sadi Konuk Training and Research Hospital Anesthesiology and Reanimation Clinic Intensive Care Unit, who received invasive mechanical ventilation support and applied prone position in the first 48 h were included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years\n* Patients diagnosed with polymerase chain reaction/computed tomography results\n* Moderate/severe severity class according to the Berlin ARDS classification\n* Prone position applied in the first 48 h after orotracheal intubation in treatment\n* Obtaining an informed consent form\n\nExclusion Criteria:\n\n* Pulmonary embolism\n* Pneumothorax\n* Heart valve disease\n* Pregnancy\n* Perforated esophageal varices\n* Coagulopathy\n* Esophageal stricture\n* Esophageal tumor\n* Neck fracture\n* Thrombocytopenia\n* Gastrointestinal bleeding\n* Previous stomach surgery\n* Previous esophageal surgery\n* Esophageal perforation'}, 'identificationModule': {'nctId': 'NCT06456606', 'briefTitle': 'Cardiopulmonary Effects of Prone Position in CARDS', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}, 'officialTitle': 'The Effect of Prone Position on Right Ventricular Functions in CARDS: is Survival Predictable When Evaluated Through Transesophageal Echocardiography?', 'orgStudyIdInfo': {'id': '2022/40'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group a', 'description': '30 moderate-to-severe C-ARDS patients who were treated with prone position in the first 48 hours of invasive mechanical ventilation support. It was evaluated with transesophageal echocardiography three times: before prone position (T0), the first hour of prone position (T1), and the first hour of returning to the supine position (T0 + 24 hours) (T2) after 23 hours prone position treatment.', 'interventionNames': ['Procedure: before prone position', 'Procedure: the first hour of prone position', 'Procedure: the first hour of returning to the supine position']}], 'interventions': [{'name': 'before prone position', 'type': 'PROCEDURE', 'otherNames': ['t0'], 'description': 'It was evaluated with transesophageal echocardiography', 'armGroupLabels': ['group a']}, {'name': 'the first hour of prone position', 'type': 'PROCEDURE', 'otherNames': ['t1'], 'description': 'It was evaluated with transesophageal echocardiography', 'armGroupLabels': ['group a']}, {'name': 'the first hour of returning to the supine position', 'type': 'PROCEDURE', 'otherNames': ['t2'], 'description': 'It was evaluated with transesophageal echocardiography', 'armGroupLabels': ['group a']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34140', 'city': 'Istanbul', 'state': 'Bakırköy', 'country': 'Turkey (Türkiye)', 'facility': 'Bakirkoy Dr. Sadi Konuk Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'Data available from the publication date can start If requested, data will be shared with medical doctors dealing with'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Dicle Birtane', 'investigatorAffiliation': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}}}}