Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-03-06 @ 7:32 AM
Study NCT ID:
NCT01608503
Status:
COMPLETED
Last Update Posted:
2013-04-23
First Post:
2012-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Deflation in Pediatric Subclavian Vein Catheterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-20', 'studyFirstSubmitDate': '2012-05-26', 'studyFirstSubmitQcDate': '2012-05-30', 'lastUpdatePostDateStruct': {'date': '2013-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The distance between the pleura and the line of the imaginary needle pathway (DPI)', 'timeFrame': 'Within 5 minutes', 'description': 'The ultra-sonography probe was adjusted to obtain an image containing the long-axis cross section of SCV, the pleura, the clavicle, and the first rib. Images were recorded by the same physician during whole respiratory cycle with the probe held in the identical position.\n\nImaginary lines for supraclavicular and infraclavicular approach were drawn, and distances from the pleura were measured.\n\nIf the pleura touched the INP, the distance was recorded as positive value. If the pleura did not touch the INP, the distance was recorded as negative value.'}], 'secondaryOutcomes': [{'measure': 'The incidence of pleural movement over the imaginary needle pathway', 'timeFrame': 'Within 5 minutes', 'description': 'If the pleura touched the imaginary needle pathway, the incidence was checked.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['subclavian vein', 'ultrasound', 'distance between the subclavian vein and the lung'], 'conditions': ['Pediatric Subclavian Vein Catheterization']}, 'descriptionModule': {'briefSummary': 'The subclavian vein (SCV) is a preferred site for placement of central venous catheter. However, pneumothorax is a major concern during subclavian venous catheterization. Lung deflation, by decreasing lung volume, may reduce the risk of pneumothorax by increasing the distance between the pleura and the SCV. The investigators evaluated the effect of lung deflation on the relative position between the pleura and the line of the imaginary needle pathway during supraclavicular and infraclavicular approach to the subclavian vein (SCV) using ultrasonography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients who were scheduled for elective operation under general anesthesia\n* Neonates (0 \\~ 1 mo), Infants (1 mo \\~ 1 yr)\n\nExclusion Criteria:\n\n* Structural anomalies of the chest wall\n* History of lung and chest wall operations\n* Prior central venous catheterization\n* Upper respiratory tract infection, or pneumonia within 2 weeks'}, 'identificationModule': {'nctId': 'NCT01608503', 'acronym': 'SCVLD', 'briefTitle': 'Lung Deflation in Pediatric Subclavian Vein Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effect of Lung Deflation on the Position of the Pleura in Mechanically Ventilated Infants During Subclavian Vein Cannulation: an Ultrasound Study', 'orgStudyIdInfo': {'id': 'SVCLungDown'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'respiration cycle', 'description': 'lung inflation and deflation', 'interventionNames': ['Procedure: lung deflation', 'Procedure: lung inflation']}], 'interventions': [{'name': 'lung deflation', 'type': 'PROCEDURE', 'description': 'lung was deflated during respiration cycle', 'armGroupLabels': ['respiration cycle']}, {'name': 'lung inflation', 'type': 'PROCEDURE', 'description': 'lung was inflated during respiratory cycle', 'armGroupLabels': ['respiration cycle']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul national university hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}