Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-07 @ 11:25 PM
Study NCT ID:
NCT03943433
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2019-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxygen Concentration During Alveolar Recruitment
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': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-13', 'studyFirstSubmitDate': '2019-05-07', 'studyFirstSubmitQcDate': '2019-05-07', 'lastUpdatePostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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 quadrant scores assessed using lung ultrasound. Each quadrant score ranges from 0 (minimal atelectasis)\\~3 (severe atelectasis), so the maximum total score is 36.'}], 'secondaryOutcomes': [{'measure': 'Modified lung ultrasound score', 'timeFrame': 'Postoperative 30 minutes', 'description': 'The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound. Each quadrant score ranges from 0 (minimal atelectasis)\\~3 (severe atelectasis), so the maximum total score is 36.'}, {'measure': '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 (20minutes after each recruitment)', 'description': 'Partial pressure of arterial oxygen/fraction of inspired oxygen ratio'}, {'measure': 'Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio', 'timeFrame': 'Postoperative 30 minutes', 'description': 'Partial pressure of arterial oxygen/fraction of inspired oxygen ratio'}, {'measure': 'Postoperative pulmonary complication', 'timeFrame': 'Postoperative 24 hours', 'description': 'respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, atelectasis, bronchospasm, aspiration pneumonitis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Absorption atelectasis', 'Lung sono', 'Oxygen concentration'], 'conditions': ['Atelectasis, Postoperative Pulmonary']}, 'referencesModule': {'references': [{'pmid': '32682397', 'type': 'DERIVED', 'citation': 'Kim BR, Lee S, Bae H, Lee M, Bahk JH, Yoon S. Lung ultrasound score to determine the effect of fraction inspired oxygen during alveolar recruitment on absorption atelectasis in laparoscopic surgery: a randomized controlled trial. BMC Anesthesiol. 2020 Jul 18;20(1):173. doi: 10.1186/s12871-020-01090-y.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of oxygen concentration during alveolar recruitment on absorption ateletasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing laparoscopic obstetric or colon surgery 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': 'NCT03943433', 'briefTitle': 'Oxygen Concentration During Alveolar Recruitment', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effect of Oxygen Concentration During Alveolar Recruitment on Absorption Atelectasis', 'orgStudyIdInfo': {'id': 'JHBahk_AR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FiO2_1.0', 'description': 'Alveolar recruitment is performed with 100% oxygen concentration at specific time points.', 'interventionNames': ['Procedure: FiO2_1.0']}, {'type': 'EXPERIMENTAL', 'label': 'FiO2_0.4', 'description': 'Alveolar recruitment is performed with 40% oxygen concentration at specific time points.', 'interventionNames': ['Procedure: FiO2_0.4']}], 'interventions': [{'name': 'FiO2_1.0', 'type': 'PROCEDURE', 'description': 'Alveolar recruitment is performed with 100% oxygen concentration after general anesthesia induction, after position change to Trendelenburg, after position change to supine, and at the end of operation.', 'armGroupLabels': ['FiO2_1.0']}, {'name': 'FiO2_0.4', 'type': 'PROCEDURE', 'description': 'Alveolar recruitment is performed with 40% oxygen concentration after general anesthesia induction, after position change to Trendelenburg, after position change to supine, and at the end of operation.', 'armGroupLabels': ['FiO2_0.4']}]}, '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'}}}}