Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT05690867
Status:
COMPLETED
Last Update Posted:
2023-01-19
First Post:
2022-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pressure Controlled Ventilation Versus Volume Controlled Ventilation in Upper Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-18', 'studyFirstSubmitDate': '2022-10-18', 'studyFirstSubmitQcDate': '2023-01-18', 'lastUpdatePostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'calculation of mechanical power changes in two different ventilation modes', 'timeFrame': 'change from at the beginning of surgery till the end of surgery', 'description': "mechanical power will be calculated using the Van der Meijden's formula for pressure support ventilation and Gattinoni's formula for volume controlled ventilation and two mechanical powers will be compared"}], 'secondaryOutcomes': [{'measure': 'postoperative pulmonary complications', 'timeFrame': 'post-operative 7 days', 'description': 'postoperative pulmonary complication including pneumonia, acute lung injury, respiratory failure requiring reintubation'}, {'measure': 'hospitalisation time', 'timeFrame': 'up to 20 days', 'description': 'up to 20 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mechanical power', 'volume controlled ventilation', 'pressure controlled ventilation'], 'conditions': ['Ventilator Lung']}, 'referencesModule': {'references': [{'pmid': '28701178', 'type': 'BACKGROUND', 'citation': 'Gattinoni L, Marini JJ, Collino F, Maiolo G, Rapetti F, Tonetti T, Vasques F, Quintel M. The future of mechanical ventilation: lessons from the present and the past. Crit Care. 2017 Jul 12;21(1):183. doi: 10.1186/s13054-017-1750-x.'}, {'pmid': '31359082', 'type': 'BACKGROUND', 'citation': 'van der Meijden S, Molenaar M, Somhorst P, Schoe A. Calculating mechanical power for pressure-controlled ventilation. Intensive Care Med. 2019 Oct;45(10):1495-1497. doi: 10.1007/s00134-019-05698-8. Epub 2019 Jul 29. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of mechanical powers produced at volume controlled and pressure controlled mechanical ventilation', 'detailedDescription': "The mechanical power created by mechanical ventilation, as a new concept, can enable to evaluate the effect of different components in the lung.Our aim in this study is to calculate mechanical power in different ventilation modes ( pressure controlled and volume controlled ventilation) and to compare them. To calculate the mechanical powers we will use Van der Meijden's mechanical power formula for pressure controlled ventilation and for volume controlled ventilation we will use Gattinoni's mechanical power formula. In the literature we haven't seen any publication comparing the mechanical power of two commonly used ventilation modes (volume controlled and pressure controlled ventilation)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ASA1-2 , \\>18 years old patients having upper abdominal surgery\n\nExclusion Criteria:\n\n* chronic obstructive lung disease, interstitial lung disease\n* chronic renal failure\n* Child-Pugh \\> 6 liver disease\n* Patients who don't give consent\n* NYHA \\> 2 heart failure"}, 'identificationModule': {'nctId': 'NCT05690867', 'briefTitle': 'Pressure Controlled Ventilation Versus Volume Controlled Ventilation in Upper Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Comparison of Pressure and Volume Controlled Ventilation in Terms of Mechanical Power in Upper Abdominal Surgery', 'orgStudyIdInfo': {'id': '2021-2081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group 1', 'description': 'group 1 starts with volume controlled ventilation', 'interventionNames': ['Other: Starting with volume controlled ventilation and changing the ventilation mode every 20 minutes']}, {'type': 'OTHER', 'label': 'Group 2', 'description': 'group 2 starts with pressure controlled ventilation', 'interventionNames': ['Other: Starting with pressure controlled ventilation and changing the ventilation mode every 20 minutes']}], 'interventions': [{'name': 'Starting with volume controlled ventilation and changing the ventilation mode every 20 minutes', 'type': 'OTHER', 'description': 'group 1 starts with volume controlled ventilation and we take three consecutive measurements in twenty minutes , after twenty minutes we change the ventilation mode to pressure controlled ventilation after letting washout we take three consecutive measurements at pressure controlled ventilation and we will repeat this protocol during surgery', 'armGroupLabels': ['Group 1']}, {'name': 'Starting with pressure controlled ventilation and changing the ventilation mode every 20 minutes', 'type': 'OTHER', 'description': 'group 2 starts with pressure controlled ventilation and we take three consecutive measurements in twenty minutes , after twenty minutes we change the ventilation mode to volume controlled ventilation after letting washout we take three consecutive measurements at volume controlled ventilation and we will repeat this protocol during surgery', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University, Department of Anesthesiology', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Istanbul University', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Reyhan Nil Kırsan', 'investigatorAffiliation': 'Istanbul University'}}}}