Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT04591327
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2020-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Atelectasis by Lung Ultrasonography in Cesarean Sections
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002585', 'term': 'Cesarean Section'}], 'ancestors': [{'id': 'D036861', 'term': 'Delivery, Obstetric'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-16', 'studyFirstSubmitDate': '2020-10-04', 'studyFirstSubmitQcDate': '2020-10-09', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of the postoperative atelectasis', 'timeFrame': 'two months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atelectasis', 'Cesarean Section']}, 'descriptionModule': {'briefSummary': 'In this study aimed to demonstrate that atelectasis developing in the perioperative period of patients undergoing elective cesarean surgery with spinal or general anesthesia methods using lung ultrasound. After Preoperative lung ultrasounds of patients is done, the cesarean operation will be completed with spinal or general anesthesia. In the postoperative period, control lung ultrasounds will be performed and the ultrasound results will be compared in terms of atelectasis in both groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Between 18-40 years old, 37-40 weeks pregnant, ASA II because of pregnancy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18-40 years\n* 37-40 weeks pregnant\n* ASA II because of pregnancy\n\nExclusion Criteria:\n\n* Emergency cesarean sections\n* who refuse to participate in the study\n* with chronic disease\n* Smoker\n* with chest deformity'}, 'identificationModule': {'nctId': 'NCT04591327', 'briefTitle': 'Atelectasis by Lung Ultrasonography in Cesarean Sections', 'organization': {'class': 'OTHER', 'fullName': 'Derince Training and Research Hospital'}, 'officialTitle': 'Determination of the Effects of General Anesthesia and Spinal Anesthesia Applied in Elective Cesarean Operations on Postoperative Atelectasis by Lung Ultrasonography', 'orgStudyIdInfo': {'id': 'U1111-1258-9377'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'general anesthesia', 'interventionNames': ['Procedure: The Effect of General Anesthesia and Spinal Anesthesia on Postoperative Atelectasis by Lung Ultrasonography in Cesarean Sections']}, {'label': 'spinal anesthesia', 'interventionNames': ['Procedure: The Effect of General Anesthesia and Spinal Anesthesia on Postoperative Atelectasis by Lung Ultrasonography in Cesarean Sections']}], 'interventions': [{'name': 'The Effect of General Anesthesia and Spinal Anesthesia on Postoperative Atelectasis by Lung Ultrasonography in Cesarean Sections', 'type': 'PROCEDURE', 'description': 'Preoperative lung ultrasound will be performed on all patients and baseline values will be recorded. The sensory block level under T10 of the patients who underwent spinal anesthesia in the postoperative period lung ultrasonography will be done after regression. In the postoperative period, lung ultrasonography will be performed in patients undergoing spinal anesthesia when the sensory block level is below T10. In the general anesthesia group, when the neuromuscular block is completely reversed and the Aldrete score is\\> 9, lung ultrasonography will be performed. The degree of atelectasis will be determined according to the modified LUS score.', 'armGroupLabels': ['general anesthesia', 'spinal anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41900', 'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli Derince Train and Research Hospital', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Derince Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'ERHAN KARACA', 'investigatorAffiliation': 'Derince Training and Research Hospital'}}}}