Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-29 @ 6:24 AM
Study NCT ID:
NCT01455766
Status:
COMPLETED
Last Update Posted:
2012-09-05
First Post:
2011-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Volumetric Monitoring in Major Lung Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood plasma for non-specified additional retrospective tests.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-04', 'studyFirstSubmitDate': '2011-10-17', 'studyFirstSubmitQcDate': '2011-10-19', 'lastUpdatePostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['postpneumonectomy pulmonary edema', 'extravascular lung water'], 'conditions': ['Pneumonectomy', 'Acute Pulmonary Edema']}, 'descriptionModule': {'briefSummary': 'The hypothesis of this observational single-center clinical study was to explore the volumetric hemodynamic monitoring in the perioperative period in major and risky thoracic intervention. The investigators monitored the changes in the volumes of blood in the central vessels and heart chambers as well as a volume of fluid in pulmonary tissue (i. e. extravascular lung water).', 'detailedDescription': 'The goal of this observational study is to investigate into changes in volumetric hemodynamic parameters obtained with a technique of transpulmonary indicator dilution after major thoracic intervention, including pneumonectomy and lobar resections. The important parameters of hemodynamics were monitored throughout the intervention and 48 hrs postoperatively, including extravascular lung water index, global end-diastolic volume index, etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes the patients scheduled for extended thoracic resections (lobar resection and pneumonectomy) due to bronchial cancer or severe destructive pulmonary infection (abscess and/or pneumonia).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* Age above 18 and below 80\n* Confirmed malignant bronchial neoplasm or\n* Destructive pulmonary infection\n\nExclusion Criteria:\n\n* Pregnant\n* Severe pulmonary hypertension\n* Pulmonary tuberculosis\n* Severe occlusive atherosclerosis of lower extremities'}, 'identificationModule': {'nctId': 'NCT01455766', 'acronym': 'EVLW-PNEUMO', 'briefTitle': 'Volumetric Monitoring in Major Lung Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Northern State Medical University'}, 'officialTitle': 'Pulmonary Edema Following Major Thoracic Resections: a Value of Perioperative Volumetric Monitoring', 'orgStudyIdInfo': {'id': '2005-2011'}}, 'contactsLocationsModule': {'locations': [{'zip': '163000', 'city': 'Arkhangelsk', 'state': 'Arkhangelskaya oblast', 'country': 'Russia', 'facility': 'Regional Hospital of Arkhangelsk', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}], 'overallOfficials': [{'name': 'Vsevolod V. Kuzkov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northern State Medical University'}, {'name': 'Mikhail M. Orlov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regional hospital of Arkhangelsk'}, {'name': 'Mikhail Y. Kirov, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Northern State Medical University'}, {'name': 'Lars J. Bjertnaes, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Trmsoe, Tromsoe, Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northern State Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regional hospital of Arkhangelsk', 'class': 'UNKNOWN'}, {'name': 'University of Tromso', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, MD, PhD', 'investigatorFullName': 'Vsevolod V. Kuzkov', 'investigatorAffiliation': 'Northern State Medical University'}}}}