Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT04327193
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2020-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Driving Pressure-guided PEEP Titration in Robot-assisted Laparoscopic Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001261', 'term': 'Pulmonary Atelectasis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-14', 'studyFirstSubmitDate': '2020-03-26', 'studyFirstSubmitQcDate': '2020-03-26', 'lastUpdatePostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified lung ultrasound score', 'timeFrame': '30 minutes after PACU administration', 'description': 'The score is calculated by adding up the 12 individual part scores assessed using lung ultrasound. The score for each part ranges from 0 to 3.'}], 'secondaryOutcomes': [{'measure': 'Modified lung ultrasound score', 'timeFrame': 'Intraoperative (at the end of operation before emergence)', 'description': 'The score is calculated by adding up the 12 individual part scores assessed using lung ultrasound. The score for each part ranges from 0 to 3.'}, {'measure': 'Incidence of intraoperative desaturation', 'timeFrame': 'Intraoperative', 'description': 'Oxygen saturation by pulse oximetry\\< 95%'}, {'measure': 'Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio', 'timeFrame': 'Intraoperative (30 minutes after designated PEEP applied)', 'description': 'Partial pressure of arterial oxygen/fraction of inspired oxygen ratio'}, {'measure': 'Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio', 'timeFrame': '30 minutes after PACU administration', 'description': 'Partial pressure of arterial oxygen/fraction of inspired oxygen ratio'}, {'measure': 'Postoperative pulmonary complications', 'timeFrame': 'After operation~ postoperative day 3', 'description': 'Extubation failure, Fever, respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, pneumonia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Driving pressure', 'Positive end-expiratory pressure', 'Lung ultrasound'], 'conditions': ['Atelectasis, Postoperative Pulmonary']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of driving-pressure guided positive end-expiratory pressure (PEEP) titration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing robot-assisted laparoscopic prostatectomy with Trendelenburg position\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists physical status IV or more\n* Severe cardiovascular disease\n* Severe chronic obstructive pulmonary disease, emphysema\n* History of pneumothorax, bullae\n* History of lung resection surgery\n* Conversion to laparotomy\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT04327193', 'briefTitle': 'Driving Pressure-guided PEEP Titration in Robot-assisted Laparoscopic Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effectiveness of Driving Pressure Based Ventilation Strategy in Robot-assisted Laparoscopic Surgeries With Steep Trendelenburg Position: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SYoon_DP_RALP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Driving pressure', 'description': 'The selected PEEP which makes the driving pressure lowest is applied during the operation.', 'interventionNames': ['Procedure: Titrated PEEP based on driving pressure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional', 'description': 'Conventional PEEP (5cmH2O) is applied.', 'interventionNames': ['Procedure: Conventional PEEP']}], 'interventions': [{'name': 'Titrated PEEP based on driving pressure', 'type': 'PROCEDURE', 'description': 'Alveolar recruitment and PEEP titration is performed at three time points: after intubation, after Trendelenburg, and after supine after CO2 deflation. The level of PEEP which makes the driving pressure lowest is selected and applied during the operation.', 'armGroupLabels': ['Driving pressure']}, {'name': 'Conventional PEEP', 'type': 'PROCEDURE', 'description': 'Alveolar recruitment is performed at three time points: after intubation, after Trendelenburg, and after supine after CO2 deflation. Conventional PEEP (5cmH2O) is applied during the operation.', 'armGroupLabels': ['Conventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'state': 'Jongnogu', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Susie Yoon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Susie Yoon', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}