Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-02-28 @ 1:48 AM
Study NCT ID:
NCT04116567
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2019-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Ultrasonography After Laparoscopic Gynecologic Surgery
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': 80}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-25', 'studyFirstSubmitDate': '2019-07-27', 'studyFirstSubmitQcDate': '2019-10-03', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess if LUS score measured after surgery is higher that LUS score measured before induction of anesthesia', 'timeFrame': 'The outcome will be measured 10 minutes after extubation', 'description': 'Each lung will be divided in 6 areas and a score from 0 to 3 will be assigned to each field depending on the loss of aereation detected by ultrasound. LUS score will range between 0 and 36. Lung ultrasound will be performed before induction of anesthesia and 10 minutes after extubation.'}, {'measure': 'Correlation between the increase of LUS score after surgery and surgical or anesthesia-related variables.', 'timeFrame': 'The outcome will be measured 10 minutes after extubation', 'description': 'Logistic regression will be applied to consider the correlation between Delta LUS and the following variables:\n\n* lenght of surgery\n* duration of pneumoperitoneum\n* angle of Trendelenburg potision\n* duration of mechanical ventilation\n* intraoperative fluids\n* duration of apnea from induction to intubation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary Atelectasis', 'Lung Ultrasound', 'Laparoscopic Surgery'], 'conditions': ['Pulmonary Atelectasis']}, 'descriptionModule': {'briefSummary': 'This study evaluates the influence of surgical and anesthesia-related variable on atelectasis formation during laparoscopic gynecologic oncologic surgery by lung ultrasound.', 'detailedDescription': "Approximately 50% of patients undergoing general anesthesia are hypoxemic. Anaesthesia, paralysis, high concentrations of oxygen, inadequate level of PEEP, capnoperitoneum, Trendelenburg position all result in persistent atelectasis. Lung ultrasound is a safe and accurate bedside tool useful to study lung aeration. The aim of the investigator's study was to assess the impact of general anesthesia and laparoscopic gynecologic oncologic surgery on post-operative atelectasis and related oxygenation changes using lung ultrasound."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients \\>18yo undergoing laparoscopy for ginecologic oncologic surgery willing to participate to the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 yo undergoing laparoscopic surgery for gynecologic surgery who provide written informed consent.\n\nExclusion Criteria:\n\n* age \\< 18 yo;\n* pregnancy;\n* refused to partecipate;\n* known pulmonary metastasis;\n* preexisting pulmonary conditions (COPD, pleural effusion, pulmonary consolidations, lung edema, pulmonary embolism);\n* anesthesia with mechanical ventilation in the 2 weeks.'}, 'identificationModule': {'nctId': 'NCT04116567', 'acronym': 'LUS-LPS', 'briefTitle': 'Lung Ultrasonography After Laparoscopic Gynecologic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Lung Ultrasonography for the Assessment of Perioperative Atelectasis After Laparoscopic Gynecologic Oncologic Surgery', 'orgStudyIdInfo': {'id': '2560'}}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'IRCCS Fondazione Policlinico Universitario Agostino Gemelli', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Luciano Frassanito, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Fondazione Universitaria Policlinico Agostino Gemelli'}, {'name': 'Gaetano Draisci, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IRCCS Fondazione Universitaria Policlinico Agostino Gemelli'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SONNINO CHIARA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Registered Anesthesiologist', 'investigatorFullName': 'SONNINO CHIARA', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}