Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-01 @ 11:28 AM
Study NCT ID:
NCT02779595
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2016-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Change of Regional Ventilation During Spontaneous Breathing After Lung Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D011015', 'term': 'Pneumonia, Aspiration'}, {'id': 'D001986', 'term': 'Bronchial Spasm'}, {'id': 'D001261', 'term': 'Pulmonary Atelectasis'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-02', 'studyFirstSubmitDate': '2016-05-17', 'studyFirstSubmitQcDate': '2016-05-17', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Association between lateral change of regional ventilation and change of forced vital capacity', 'timeFrame': 'baseline, 3., 5. and 7. postoperative day', 'description': "Correlation testing is done on the ipsi- and contralateral change in the calculated 'Center of Ventilation' and the forced vital capacity in % of normal (FVC%) by spirometry"}, {'measure': 'Sagittal change from baseline in regional ventilation', 'timeFrame': 'baseline, 3., 5. and 7. postoperative day', 'description': "Regional ventilation is measured by pulmonary electrical impedance tomography. The sagittal change in the calculated 'Center of Ventilation' is evaluated"}, {'measure': 'Association between sagittal change of regional ventilation and change of forced vital capacity', 'timeFrame': 'baseline, 3., 5. and 7. postoperative day', 'description': "Correlation testing is done sagittal change in the calculated 'Center of Ventilation' and the forced vital capacity in % of normal (FVC%) by spirometry"}, {'measure': 'Time shift in regional ventilation between ipsi- and contralateral lung', 'timeFrame': 'baseline, 3., 5. and 7. postoperative day', 'description': 'Regional ventilation is measured by pulmonary electrical impedance tomography. The shift in time of occurence of ipsi- and contralateral Ventilation is evaluated'}, {'measure': 'Impact on flail chest surgery to change from baseline in regional ventilation', 'timeFrame': 'baseline, 3., 5. and 7. postoperative day', 'description': 'Measured by EIT'}], 'primaryOutcomes': [{'measure': 'Lateral Change from baseline in regional ventilation', 'timeFrame': 'baseline and 3. postoperative day', 'description': "Regional ventilation is measured by pulmonary electrical impedance tomography. The ipsi- and contralateral change in the calculated 'Center of Ventilation' is evaluated"}], 'secondaryOutcomes': [{'measure': 'Lateral Change from baseline in regional ventilation depending on side of surgery', 'timeFrame': 'baseline and 3. postoperative day', 'description': "Regional ventilation is measured by pulmonary electrical impedance tomography. The influence of the side of surgery on the ipsi- and contralateral change in the calculated 'Center of Ventilation' is evaluated"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pulmonary Infection', 'Respiratory Insufficiency', 'Aspiration Pneumonitis', 'Bronchospasm', 'Atelectasis']}, 'referencesModule': {'references': [{'pmid': '21045639', 'type': 'BACKGROUND', 'citation': 'Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.'}, {'pmid': '24901240', 'type': 'BACKGROUND', 'citation': 'Mazo V, Sabate S, Canet J, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P. Prospective external validation of a predictive score for postoperative pulmonary complications. Anesthesiology. 2014 Aug;121(2):219-31. doi: 10.1097/ALN.0000000000000334.'}, {'pmid': '8942326', 'type': 'BACKGROUND', 'citation': 'Karayiannakis AJ, Makri GG, Mantzioka A, Karousos D, Karatzas G. Postoperative pulmonary function after laparoscopic and open cholecystectomy. Br J Anaesth. 1996 Oct;77(4):448-52. doi: 10.1093/bja/77.4.448.'}, {'pmid': '20963310', 'type': 'BACKGROUND', 'citation': 'Guizilini S, Bolzan DW, Faresin SM, Alves FA, Gomes WJ. Ministernotomy in myocardial revascularization preserves postoperative pulmonary function. Arq Bras Cardiol. 2010 Oct;95(5):587-93. doi: 10.1590/s0066-782x2010005000137. Epub 2010 Oct 15. English, Portuguese.'}, {'pmid': '23074580', 'type': 'BACKGROUND', 'citation': 'Davoudi M, Farhanchi A, Moradi A, Bakhshaei MH, Safarpour G. The Effect of Low Tidal Volume Ventilation during Cardiopulmonary Bypass on Postoperative Pulmonary Function. J Tehran Heart Cent. 2010 Summer;5(3):128-31. Epub 2010 Aug 31.'}, {'pmid': '22992946', 'type': 'BACKGROUND', 'citation': 'Leonhardt S, Lachmann B. Electrical impedance tomography: the holy grail of ventilation and perfusion monitoring? Intensive Care Med. 2012 Dec;38(12):1917-29. doi: 10.1007/s00134-012-2684-z. Epub 2012 Sep 20.'}, {'pmid': '22531334', 'type': 'BACKGROUND', 'citation': 'Radke OC, Schneider T, Heller AR, Koch T. Spontaneous breathing during general anesthesia prevents the ventral redistribution of ventilation as detected by electrical impedance tomography: a randomized trial. Anesthesiology. 2012 Jun;116(6):1227-34. doi: 10.1097/ALN.0b013e318256ee08.'}, {'pmid': '23877309', 'type': 'BACKGROUND', 'citation': 'Karsten J, Heinze H, Meier T. Impact of PEEP during laparoscopic surgery on early postoperative ventilation distribution visualized by electrical impedance tomography. Minerva Anestesiol. 2014 Feb;80(2):158-66. Epub 2013 Jul 23.'}, {'pmid': '9689281', 'type': 'BACKGROUND', 'citation': 'Frerichs I, Hahn G, Golisch W, Kurpitz M, Burchardi H, Hellige G. Monitoring perioperative changes in distribution of pulmonary ventilation by functional electrical impedance tomography. Acta Anaesthesiol Scand. 1998 Jul;42(6):721-6. doi: 10.1111/j.1399-6576.1998.tb05308.x.'}, {'pmid': '21261780', 'type': 'BACKGROUND', 'citation': 'Reifferscheid F, Elke G, Pulletz S, Gawelczyk B, Lautenschlager I, Steinfath M, Weiler N, Frerichs I. Regional ventilation distribution determined by electrical impedance tomography: reproducibility and effects of posture and chest plane. Respirology. 2011 Apr;16(3):523-31. doi: 10.1111/j.1440-1843.2011.01929.x.'}, {'pmid': '25398109', 'type': 'BACKGROUND', 'citation': 'Guerin C, Frerichs I. Getting a better picture of the correlation between lung function and structure using electrical impedance tomography. Am J Respir Crit Care Med. 2014 Nov 15;190(10):1186-7. doi: 10.1164/rccm.201405-0812IM. No abstract available.'}, {'pmid': '18431279', 'type': 'BACKGROUND', 'citation': 'Wrigge H, Zinserling J, Muders T, Varelmann D, Gunther U, von der Groeben C, Magnusson A, Hedenstierna G, Putensen C. Electrical impedance tomography compared with thoracic computed tomography during a slow inflation maneuver in experimental models of lung injury. Crit Care Med. 2008 Mar;36(3):903-9. doi: 10.1097/CCM.0B013E3181652EDD.'}]}, 'descriptionModule': {'briefSummary': 'Perioperative changes in regional ventilation by pulmonary electrical impedance tomography and spirometry will be investigated in patients at risk for postoperative pulmonary complications. Those patients undergo lung and flail chest surgery.', 'detailedDescription': "Postoperative pulmonary complications (Defined as pulmonary infection, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis or respiratory insufficiency subsequent to surgery) increase the morbidity and mortality of surgical patients. Several independent factors determined by the patients' characteristics and the operative procedure increase the risk for those complications. The postoperative decrease of values measured by spirometry, such as the forced vital capacity (FVC) and forced expiratory volume in one second (FEV1), were found in patients after major surgical procedures for several days. The postoperative reduction of those measurement can be the result of general functional limitations in those patients (e.g. by postoperative pain) or the result of a regional postoperative pulmonary complication (e.g. atelectasis, pleural effusion). The method of the electrical impedance tomography (EIT) enables to visualize the regional ventilation within a transversal section of the lung in real time. Studies examining the change of pulmonary EIT for several days postoperatively in spontaneously breathing patients are lacking. The aim of the present study is to examine perioperative changes in regional ventilation in spontaneously breathing patients during their recovery after lung and flail chest surgery. Moreover, the association of those changes with expected changes in spirometry is tested. Finally, in patients with evident postoperative pulmonary complications the value of pulmonary EIT to detect those changes is investigated. The study should improve the knowledge about the development of postoperative pulmonary complications and test the scientific and clinical value of pulmonary EIT in those spontaneously breathing patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult inpatients undergoing elective surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult\n* Inpatient\n* Lung surgery under general anaesthesia\n\nExclusion Criteria:\n\n* Missing informed consent\n* Outpatient\n* Emergency procedure\n* Revision surgery of hospitalized patients\n* Pneumothorax\n* Pleural effusion\n* Pleural effusion or pleural empyema with need to cannulate\n* scheduled Pneumonectomy\n* Expected hospital stay of less than three days\n* Pregnancy\n* Allergy against material of the electrode belt (silicone rubber, stainless steel, gold-plated brass)\n* Injured, inflamed or otherwise affected skin within the target region of the electrode belt\n* Unstable spine injury\n* Body mass index of more than 50 kg/m2\n* Incapacity to lie quietly for the examination\n* Pacemaker, defibrillator or other active implant\n* Reoperation before the examination at the third postoperative day\n\nExclusion criteria during clinical course:\n\n* performed pneumonectomy\n* Reoperation\n* postoperative ventilation at the third day'}, 'identificationModule': {'nctId': 'NCT02779595', 'briefTitle': 'Change of Regional Ventilation During Spontaneous Breathing After Lung Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Wuerzburg University Hospital'}, 'officialTitle': 'Change of Regional Ventilation During Spontaneous Breathing After Lung Surgery', 'orgStudyIdInfo': {'id': 'thoraxEIT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lung surgery', 'description': '26 patients (up to 36) undergoing lung surgery having an elevated risk for postoperative pulmonary complications will be examined by perioperative pulmonary function tests', 'interventionNames': ['Other: Perioperative pulmonary function tests']}, {'label': 'Flail chest', 'description': '8 patients undergoing an operative stabilization of a flail chest will be examined by perioperative pulmonary function tests', 'interventionNames': ['Other: Perioperative pulmonary function tests']}], 'interventions': [{'name': 'Perioperative pulmonary function tests', 'type': 'OTHER', 'description': 'Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the the third, fifth and seventh postoperative day', 'armGroupLabels': ['Flail chest', 'Lung surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'University of Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'overallOfficials': [{'name': 'Markus Kredel, PD.Dr.med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Würzburg, Department of Anaesthesia and Critical Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}