Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-06-21 @ 3:35 PM
Study NCT ID:
NCT03770793
Status:
COMPLETED
Last Update Posted:
2020-11-12
First Post:
2018-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Lung Sono in One-lung Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-09', 'studyFirstSubmitDate': '2018-12-06', 'studyFirstSubmitQcDate': '2018-12-06', 'lastUpdatePostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of desaturation', 'timeFrame': 'intraoperative', 'description': 'SpO2\\<95%'}, {'measure': 'P/F ratio', 'timeFrame': '30 minutes after one-lung ventilation', 'description': 'PaO2/FiO2 ratio'}], 'secondaryOutcomes': [{'measure': 'Lung ultrasound score', 'timeFrame': 'just after anesthesia induction, end of surgery', 'description': 'Lung ultrasound score of atelectasis'}, {'measure': 'Alveolar dead space', 'timeFrame': '30 minutes after one-lung ventilation', 'description': '(PaCO2-PetCO2)xVt/PaCO2'}, {'measure': 'Pulmonary complications', 'timeFrame': 'intraoperative, during hospital stay(an average of 3 days)', 'description': 'respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, atelectasis, bronchospasm, aspiration pneumonitis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['One lung ventilation', 'Lung ultrasound', 'Alveolar recruitment'], 'conditions': ['One Lung Ventilation']}, 'referencesModule': {'references': [{'pmid': '29309282', 'type': 'BACKGROUND', 'citation': 'Song IK, Kim EH, Lee JH, Kang P, Kim HS, Kim JT. Utility of Perioperative Lung Ultrasound in Pediatric Cardiac Surgery: A Randomized Controlled Trial. Anesthesiology. 2018 Apr;128(4):718-727. doi: 10.1097/ALN.0000000000002069.'}, {'pmid': '40581064', 'type': 'DERIVED', 'citation': 'Kim BR, Lim L, You J, Yoon S, Park JB, Bahk JH, Seo JH. Effectiveness of ultrasound-guided alveolar recruitment in thoracic surgery with one-lung ventilation: a randomized-controlled trial. Eur J Cardiothorac Surg. 2025 Jul 1;67(7):ezaf204. doi: 10.1093/ejcts/ezaf204.'}]}, 'descriptionModule': {'briefSummary': 'To observe the effectiveness of ultrasound-guided alveolar recruitment in thoracic surgery with one-lung ventilation(OLV).', 'detailedDescription': 'One-lung ventilation(OLV) is essential in thoracic surgery for patient safety and better surgical view. However, pulmonary complications such as hypoxemia may be caused by OLV which might be preventable with adequate alveolar recruitment and positive end-expiratory pressure(PEEP). Alveolar recruitment has been performed with conventional methods without diagnostic tools in clinical setting.\n\nUltrasound is a non-invasive, radiation-free device with high accuracy for the diagnosis of lung atelectasis. There are a few reports regarding the usefulness of lung ultrasound in other surgeries, but not in thoracic surgeries with OLV.\n\nThus, investigators designed a study to observe the effectiveness of ultrasound-guided alveolar recruitment in thoracic surgery with OLV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective thoracic surgery which requires one-lung ventilation with lateral decubitus position\n\nExclusion Criteria:\n\n* Patients who refuse to agree\n* Previous lung surgical history\n* History of pneumothorax or bullae\n* Severe cardiopulmonary disease, COPD\n* Operation time \\< 1hr'}, 'identificationModule': {'nctId': 'NCT03770793', 'briefTitle': 'Effectiveness of Lung Sono in One-lung Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effectiveness of Ultrasound-guided Alveolar Recruitment in Thoracic Surgery With One-lung Ventilation', 'orgStudyIdInfo': {'id': 'JHSeo_LungSono'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lung-sono guided', 'description': 'Before starting one-lung ventilation, alveolar recruitment is performed under the examination with ultrasound. Find the minimal airway pressure that actually starts to resolve the observed atelectasis. Repeat alveolar recruitment with the minimal pressure untill the atlelectasis is not visible.', 'interventionNames': ['Procedure: Lung-sono guided']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional', 'description': 'Before starting one-lung ventilation, alveolar recruitment is performed with the pressure of 30mmHg for 10 seconds which is a conventional method.'}], 'interventions': [{'name': 'Lung-sono guided', 'type': 'PROCEDURE', 'description': 'The patient undergoing thoracic surgery is intubated with double lumen tube after induction of general anesthesia with propofol and remifentanil.\n\nIn the intervention group, alveolar recruitment is performed to the non-surgical side of lung under examination with ultrasound just after anesthesia induction.\n\nDuring the gradual increment in the pressure of recruitment, the anesthesiologist can find the opening pressure that means the minimal pressure at which observed atelectasis starts to disappear.\n\nThen, alveolar recruitment is performed with the opening pressure until the atelectasis is not visible.', 'armGroupLabels': ['Lung-sono guided']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jeong-Hwa Seo, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeong-Hwa Seo', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}