Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
Study NCT ID:
NCT06088966
Status:
UNKNOWN
Last Update Posted:
2023-10-18
First Post:
2023-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Hemodynamic and Ventilatory Effects of Negative Pressure Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002303', 'term': 'Cardiac Output, Low'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-11', 'studyFirstSubmitDate': '2023-10-03', 'studyFirstSubmitQcDate': '2023-10-11', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stroke Volume Index in ml/m2', 'timeFrame': '1 hour'}], 'secondaryOutcomes': [{'measure': 'Heart rate in beats/min', 'timeFrame': '1 hour'}, {'measure': 'blood pressure in mm/Hg', 'timeFrame': '1 hour'}, {'measure': 'arterial oxygen saturation in %', 'timeFrame': '1 hour'}, {'measure': 'mixed venous oxygen saturation in %', 'timeFrame': '1 hour', 'description': 'measured via pulmonary catheter'}, {'measure': 'right ventricular ejection fraction in %', 'timeFrame': '1 hour', 'description': 'measured via pulmonary catheter'}, {'measure': 'end diastolic volume index in ml/m2', 'timeFrame': '1 hour', 'description': 'measured via pulmonary catheter'}, {'measure': 'Cardiac index in l/min/m2', 'timeFrame': '1 hour', 'description': 'measured via pulmonary catheter'}, {'measure': 'tricuspid annular plane systolic excursion in mm', 'timeFrame': '1 hour', 'description': 'measured via transesophageal echocardiography'}, {'measure': 'right ventricular fractional area change in %', 'timeFrame': '1 hour', 'description': 'measured via transesophageal echocardiography'}, {'measure': 'Vena contract of tricuspid valve in mm', 'timeFrame': '1 hour', 'description': 'measured via transesophageal echocardiography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Output, Low']}, 'referencesModule': {'references': [{'pmid': '40744972', 'type': 'DERIVED', 'citation': 'Schemke S, Grunewald H, Schemke L, Franzen K, Hirschl D, Heringlake M, Muras L. A pilot study on the hemodynamic effects of negative pressure ventilation in patients after cardiac surgery focussing on right ventricular function. Sci Rep. 2025 Jul 31;15(1):27974. doi: 10.1038/s41598-025-12534-1.'}]}, 'descriptionModule': {'briefSummary': 'Investigation of the effects of negative pressure ventilation after cardiac surgery in adults onto performance of the left and right heart and the lungs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients after surgery without exclusion criteria', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with pulmonary artery catheter after cardiac surgery\n\nExclusion Criteria:\n\n* minimally invasive surgery\n* unstable conditions\n* bleeding\n* unability to fit cuirass'}, 'identificationModule': {'nctId': 'NCT06088966', 'briefTitle': 'Evaluation of Hemodynamic and Ventilatory Effects of Negative Pressure Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Karlsburg Hospital'}, 'officialTitle': 'Evaluation of Hemodynamic and Ventilatory Effects of Negative Pressure Ventilation', 'orgStudyIdInfo': {'id': 'KAIKB-2023-2'}}, 'contactsLocationsModule': {'locations': [{'zip': '17495', 'city': 'Karlsburg', 'state': 'Mecklenburg-Vorpommern', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Matthias Heringlake, Prof. Dr.', 'role': 'CONTACT', 'email': 'anaesthesie.karlsburg@klinikumkarlsburg.de', 'phone': '+4938355700'}, {'name': 'Simon Schemke, Dr.', 'role': 'CONTACT', 'email': 'anaesthesie.karlsburg@klinikumkarlsburg.de', 'phone': '+4938355700'}], 'facility': 'Klinikum Karlsburg, Klinik für Anästhesiologie', 'geoPoint': {'lat': 53.97172, 'lon': 13.61007}}], 'centralContacts': [{'name': 'Matthias Heringlake, Prof. Dr.', 'role': 'CONTACT', 'email': 'anaesthesie.karlsburg@klinikumkarlsburg.de', 'phone': '004938355700'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karlsburg Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor and head of the department of anesthesiology and intensive care Prof. Dr. Matthias Heringlake', 'investigatorFullName': 'Prof. Dr. Matthias Heringlake', 'investigatorAffiliation': 'Karlsburg Hospital'}}}}