Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-04 @ 1:33 AM
Study NCT ID:
NCT04008758
Status:
UNKNOWN
Last Update Posted:
2023-03-06
First Post:
2019-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recruitment Maneuver Using Lung Ultrasound in Trauma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized prospective trial\n\n1. st group is sono group using lung ultrasound\n2. nd group is control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-03', 'studyFirstSubmitDate': '2019-07-02', 'studyFirstSubmitQcDate': '2019-07-02', 'lastUpdatePostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'arterial oxygen partial pressure / fractional inspired oxygen ratio at end of surgery', 'timeFrame': '2 hours', 'description': '= P /F ratio; Smaller value respresents poor outcome Using arterial blood gas analysis the difference between baseline (immediate after intubation) and end of surgery\n\n: If P/F ratio difference is improved compared to baseline, it means recruitment maneuver is effective'}], 'secondaryOutcomes': [{'measure': 'Lung ultrasound score', 'timeFrame': '2 hours', 'description': 'Using lung ultrasound, evaluate lung condition in both group at end of surgery Scoring using "lung ultrasound scoring" Scoring range: 0, normal; 1, small loss of aeration; 2, moderate loss of aeration; 4, severe loss of aeration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['recruitment', 'ultrasound', 'trauma', 'pulmonary contusion'], 'conditions': ['Recruitment', 'Trauma']}, 'descriptionModule': {'briefSummary': 'In trauma patients, the incidence of pulmonary contusion is frequent. Recruit maneuver using lung ultrasound could be improve oxygenation in trauma populatioin, howevere, there is no previous study. The aim of this study is evaluation of the efficacy of lung recruitment using ultrasound in perioperative period in trauma patients.', 'detailedDescription': 'In trauma patients, the incidence of pulmonary contusion is 17-75%. Pulmonary contusioin leads to atelectasis, lung consolidatioin. Finally it could results acute respiratory distress syndrome.\n\nLung ultrasound is non-invasive and available in anytime even during surgery. Previous studies showed recruitment maneuver using ultrasound improved postoperative oxygenation in pediatric cardiac surgery. In adults, recruitment maneuver not using ultrasound improved oxygenation after cardiopulmonary bypass. There is no study in adult trauma population.\n\nThe aim of this study is evaluation of the efficacy of lung recruitment using ultrasound in perioperative period in trauma patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Who need surgery under general anesthesia due to trauma\n* The position of the surgery is supine\n\nExclusion Criteria:\n\n* Who has been ventilator care before the surgery\n* Thoracic surgery\n* Who had cardiopulmonary resuscitation\n* Who has acute respiratory distress syndrome'}, 'identificationModule': {'nctId': 'NCT04008758', 'briefTitle': 'Recruitment Maneuver Using Lung Ultrasound in Trauma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Evaluation of Efficacy of Recruitment Maneuver Using Lung Ultrasound in Trauma Patients', 'orgStudyIdInfo': {'id': 'AJIRB-MED-OBS-19-119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sono group', 'description': "Evaluate the participant's lung condition using ultrasound and do recruitment maneuver if it is necessary", 'interventionNames': ['Diagnostic Test: Ultrasound']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'If participants need recruitment maneuver (decreasing saturation, peak airway pressure \\> 35 mmHg) by clinical judgement, do recruitment maneuver not using lung ultrasound'}], 'interventions': [{'name': 'Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': "Evaluate participant's lung condition using ultrasound. Using lung ultrasound scoring, more than 1 point needs recruitment maneuver", 'armGroupLabels': ['sono group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16499', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'In Kyong Yi, MD', 'role': 'CONTACT', 'email': 'lyrin01@gmail.com', 'phone': '+82-10-3012-6972'}], 'facility': 'Ajou university school of medicine', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'centralContacts': [{'name': 'In Kyong Yi, MD', 'role': 'CONTACT', 'email': 'lyrin01@gmail.com', 'phone': '+82-219-7522'}, {'name': 'Hyemin Sohn, MD', 'role': 'CONTACT', 'email': 'sfsohn@aumc.ac.kr', 'phone': '+82-219-7521'}], 'overallOfficials': [{'name': 'In Kyong Yi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical assistant professor', 'investigatorFullName': 'In-kyong Yi', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}