Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-02-02 @ 3:21 AM
Study NCT ID:
NCT05528159
Status:
COMPLETED
Last Update Posted:
2024-07-09
First Post:
2022-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Ultrasound Score (LUS) Change in Robotic and Laparoscopic Urologic 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-06', 'studyFirstSubmitDate': '2022-09-01', 'studyFirstSubmitQcDate': '2022-09-01', 'lastUpdatePostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LUS change between T3 and T1', 'timeFrame': 'Up to 6 hours', 'description': 'LUS will be evaluated at the start of the surgery right after intubation (T1) and 30 minutes after the extubation (T3). LUS refers to "lung ultrasound score" . Accordingly, one hemithorax is divided into 6 zones where the ultrasound probe is placed. If there is only A lines (no consolidation) observed, it is accepted as zero points. If there are three or less B lines (vertical lines that move with the respiration), it refers to 1 point. Four or more vertical B lines refer to 2 points, and lastly distinct visible atelectasis with converged B lines and disrupted pleura refer to 3 points. In total, ultrasonography is applied on 12 different zones, and sum of the points show the actual LUS. Less points mean lungs with better condition, and higher points reflect lungs with atelectasis and consolidation. Therefore a 36 points LUS indicates severely injured lungs.'}], 'secondaryOutcomes': [{'measure': 'Delta T (T2-T1) and surgical duration relation', 'timeFrame': 'Up to 6 hours', 'description': 'Intraoperative LUS change will be evaluated in relation to surgical duration. LUS refers to "lung ultrasound score" . Accordingly, one hemithorax is divided into 6 zones where the ultrasound probe is placed. If there is only A lines (no consolidation) observed, it is accepted as zero points. If there are three or less B lines (vertical lines that move with the respiration), it refers to 1 point. Four or more vertical B lines refer to 2 points, and lastly distinct visible atelectasis with converged B lines and disrupted pleura refer to 3 points. In total, ultrasonography is applied on 12 different zones, and sum of the points show the actual LUS. Less points mean lungs with better condition, and higher points reflect lungs with atelectasis and consolidation. Therefore a 36 points LUS indicates severely injured lungs.'}, {'measure': 'Perioperative PaO2 analysis and its relation to T3 LUS', 'timeFrame': 'Up to 6 hours', 'description': 'PaO2 values will be evaluated at T3 time point to observe its relation with LUS scores. LUS refers to "lung ultrasound score" . Accordingly, one hemithorax is divided into 6 zones where the ultrasound probe is placed. If there is only A lines (no consolidation) observed, it is accepted as zero points. If there are three or less B lines (vertical lines that move with the respiration), it refers to 1 point. Four or more vertical B lines refer to 2 points, and lastly distinct visible atelectasis with converged B lines and disrupted pleura refer to 3 points. In total, ultrasonography is applied on 12 different zones, and sum of the points show the actual LUS. Less points mean lungs with better condition, and higher points reflect lungs with atelectasis and consolidation. Therefore a 36 points LUS indicates severely injured lungs.'}, {'measure': 'Intergroup oxygenation difference', 'timeFrame': 'Up to 6 hours', 'description': 'T3 PaO2 values will be compared in laparoscopic and robotic surgery groups.'}, {'measure': 'Perioperative PaCO2 analysis and its relation to T3 LUS', 'timeFrame': 'Up to 6 hours', 'description': 'PaCO2 values will be evaluated at T3 time point to observe its relation with LUS scores. LUS refers to "lung ultrasound score" . Accordingly, one hemithorax is divided into 6 zones where the ultrasound probe is placed. If there is only A lines (no consolidation) observed, it is accepted as zero points. If there are three or less B lines (vertical lines that move with the respiration), it refers to 1 point. Four or more vertical B lines refer to 2 points, and lastly distinct visible atelectasis with converged B lines and disrupted pleura refer to 3 points. In total, ultrasonography is applied on 12 different zones, and sum of the points show the actual LUS. Less points mean lungs with better condition, and higher points reflect lungs with atelectasis and consolidation. Therefore a 36 points LUS indicates severely injured lungs.'}, {'measure': 'Intraoperative compliance change', 'timeFrame': 'Up to 6 hours', 'description': 'dynamic compliance change between T2 and T1.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atelectasis']}, 'referencesModule': {'references': [{'pmid': '40069409', 'type': 'DERIVED', 'citation': 'Vuran Yaz I, Bingul ES, Canbaz M, Aygun E, Sanli MO, Ozcan F, Savran Karadeniz M. Evaluation of perioperative lung ultrasound scores in robotic radical prostatectomy: prospective observational study. J Robot Surg. 2025 Mar 11;19(1):112. doi: 10.1007/s11701-025-02272-x.'}]}, 'descriptionModule': {'briefSummary': 'Robotic and laparoscopic surgeries are tend to cause lung atelectasis due to the insufflation of CO2 into abdomen. However, ultrasonographic measurement for this phenomenon and its clinical use is not well investigated. In this particular study, It is aimed to observe lung ultrasound score (LUS) changes in robotic and laparoscopic supine position surgeries such as prostatectomies and cystectomies. LUS is a pragmatic measurement method that calculates the degree of atelectasis and consolidation in the lungs. Both hemithoraxes are separated into 3 different segments with vertical lines (one between the parasternal line and anterior axillary line, one between the anterior and posterior axillary line, and one posterior to the posterior axillary line). These vertical segments are also divided into two with an horizontal line on the nipple. Lung ultrasonography is applied in all 12 zones for both lungs in the intercostal regions and a scoring system is used. Accordingly, pure A lines (transverse frequent lines) reflects normal lung tissue with no consolidation and scored as zero points (Also named "A"). If less than 4 B lines (vertical lines reflecting some degree of consolidation) is observed, it refers to 1 point (named "B1"). 4 or more B lines refers to 2 points (B2), and if wide and coalesced B lines or patchy pleural line is observed that refers to 3 points (C). All evaluations will be made in supine position.\n\nIn this trial, LUS will be applied in three different time points:\n\nT1: 5 minutes after orotracheal intubation T2: At the end of surgery, before extubation (under deep anesthetic state) T3: 30 minutes after extubation, in postanesthesia care unit During the surgery and the postoperative care period standart monitorization and mechanical ventilation data will be gathered. Also intraoperative and postoperative blood gas analysis will be obtained to observe oxygenation changes.\n\nThis study is planned as a prospective observational study and our hypothesis is that LUS scores would be lower in acute postoperative period with robotic and laparoscopic surgeries. Therefore primary outcome is the numeric change in T3 and T1. Secondarily, LUS scores will be evaluated between robotic group and laparoscopic group patients for all time points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients scheduled for semi-elective/elective robotic and laparoscopic urologic surgeries that require supine/trendelenburg', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years\n* Laparoscopic urologic surgeries\n* Robotic urologic surgeries\n* Surgeries under supine and trendelenburg position\n\nExclusion Criteria:\n\n* Known lung disease\n* Emergency surgeries\n* Known cardiac failure\n* Known pulmonary hypertension\n* Patients receiving inhaled agents\n* Patients requiring lateral position surgeries'}, 'identificationModule': {'nctId': 'NCT05528159', 'briefTitle': 'Lung Ultrasound Score (LUS) Change in Robotic and Laparoscopic Urologic Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Perioperative Lung Ultrasound Score (LUS) Changes in Robotic and Laparoscopic Urologic Surgeries: A Prospective Observational Trial', 'orgStudyIdInfo': {'id': '2022/1056'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Robotic and Laparoscopic Urologic Surgery Group', 'description': 'Patients scheduled for robotic/laparoscopic urologic surgeries that will be performed under supine and trendelenburg position', 'interventionNames': ['Procedure: Intraabdominal CO2 insufllation']}], 'interventions': [{'name': 'Intraabdominal CO2 insufllation', 'type': 'PROCEDURE', 'description': 'Patients will receive intraabdominal CO2 insufflation and will be operated under trendelenburg position', 'armGroupLabels': ['Robotic and Laparoscopic Urologic Surgery Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Meltem Savran Karadeniz', 'investigatorAffiliation': 'Istanbul University'}}}}