Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT03856918
Status:
COMPLETED
Last Update Posted:
2022-04-18
First Post:
2019-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimal Level of PEEP in Protective One-lung Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-15', 'studyFirstSubmitDate': '2019-02-26', 'studyFirstSubmitQcDate': '2019-02-26', 'lastUpdatePostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified lung ultrasound score', 'timeFrame': 'Postoperative 1 hour', 'description': 'The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound.'}], 'secondaryOutcomes': [{'measure': 'Intraoperative desaturation', 'timeFrame': 'Average time of 60-90 minutes', 'description': 'Oxygen saturation by pulse oximetry \\<95% during one-lung ventilation'}, {'measure': 'Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio', 'timeFrame': 'Average time of 60-90 minutes', 'description': 'partial pressure of arterial oxygen/fraction of inspired oxygen ratio during one-lung ventilation'}, {'measure': 'Postoperative desaturation', 'timeFrame': 'Postoperative 24 hours', 'description': 'Oxygen saturation by pulse oximetry \\<95%'}, {'measure': 'plasma Tumor Necrosis Factor-α', 'timeFrame': '10 minutes after initiation of one-lung ventilation', 'description': 'proinflammatory cytokine'}, {'measure': 'plasma Interleukin-6', 'timeFrame': '10 minutes after initiation of one-lung ventilation', 'description': 'proinflammatory cytokine'}, {'measure': 'plasma Interleukin-10', 'timeFrame': '10 minutes after initiation of one-lung ventilation', 'description': 'anti-inflammatory cytokine'}, {'measure': 'Postoperative pulmonary complication', 'timeFrame': 'Postoperative 7 days', 'description': 'Composite outcome of atelectasis, pneumonia, acute respiratory distress syndrome, or pulmonary aspiration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Protective ventilation', 'One-lung ventilation'], 'conditions': ['Video-assisted Thoracic Surgery', 'Postoperative Atelectasis', 'Positive End-expiratory Pressure']}, 'descriptionModule': {'briefSummary': 'Protective ventilation strategy has been widely applied in the field of thoracic surgery requiring one-lung ventilation to reduce postoperative pulmonary complications. Low tidal volume, positive end-expiratory pressure (PEEP), and intermittent recruitment maneuver are key components of protective ventilation strategy. Recent evidence suggests that a tidal volume of 4-5 ml/kg should be applied during protective one-lung ventilation. However, optimal level of PEEP is still unclear. This study aims to investigate optimal level of PEEP to minimize postoperative atelectasis by comparing modified lung ultrasound score in patients applied protective one-lung ventilation using PEEP of 3, 6, or 9 cm of water during thoracic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing Video-assisted Thoracic Surgery under one-lung ventilation\n\nExclusion Criteria:\n\n* Moderate to severe obstructive/restrictive pattern in preoperative pulmonary function test\n* Chronic kidney disease\n* Coronary artery disease\n* Pulmonary hypertension\n* Bilateral lung surgery\n* Conversion to thoracotomy\n* American Society of Anesthesiologists physical status IV or more\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT03856918', 'briefTitle': 'Optimal Level of PEEP in Protective One-lung Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Optimal Level of Positive End-expiratory Pressure to Reduce Postoperative Atelectasis After Lung Resection With Protective One-lung Ventilation', 'orgStudyIdInfo': {'id': 'H-1901-086-1004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEEP 3 cm of water', 'description': 'Patients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 3 cm of water during thoracic surgery.', 'interventionNames': ['Procedure: PEEP 3 cm of water']}, {'type': 'EXPERIMENTAL', 'label': 'PEEP 6 cm of water', 'description': 'Patients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 6 cm of water during thoracic surgery.', 'interventionNames': ['Procedure: PEEP 6 cm of water']}, {'type': 'EXPERIMENTAL', 'label': 'PEEP 9 cm of water', 'description': 'Patients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 9 cm of water during thoracic surgery.', 'interventionNames': ['Procedure: PEEP 9 cm of water']}], 'interventions': [{'name': 'PEEP 3 cm of water', 'type': 'PROCEDURE', 'description': 'PEEP of 3 cm of water will be applied during one-lung ventilation.', 'armGroupLabels': ['PEEP 3 cm of water']}, {'name': 'PEEP 6 cm of water', 'type': 'PROCEDURE', 'description': 'PEEP of 6 cm of water will be applied during one-lung ventilation.', 'armGroupLabels': ['PEEP 6 cm of water']}, {'name': 'PEEP 9 cm of water', 'type': 'PROCEDURE', 'description': 'PEEP of 9 cm of water will be applied during one-lung ventilation.', 'armGroupLabels': ['PEEP 9 cm of water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jae-Hyon Bahk, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jae-Hyon Bahk, MD, PhD', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}