Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2026-01-29 @ 3:10 PM
Study NCT ID:
NCT03184961
Status:
COMPLETED
Last Update Posted:
2020-05-29
First Post:
2017-06-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Recruitment Maneuver for Predicting Fluid Responsiveness in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020896', 'term': 'Hypovolemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-27', 'studyFirstSubmitDate': '2017-06-08', 'studyFirstSubmitQcDate': '2017-06-11', 'lastUpdatePostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'photoplethysmographic waveform', 'timeFrame': 'change from baseline photoplethysmographic waveform after lung recruitment maneuver within 30 seconds'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypovolemia']}, 'referencesModule': {'references': [{'pmid': '33186310', 'type': 'DERIVED', 'citation': 'Kim EH, Lee JH, Jang YE, Ji SH, Kim HS, Cho SA, Kim JT. Prediction of fluid responsiveness using lung recruitment manoeuvre in paediatric patients receiving lung-protective ventilation: A prospective observational study. Eur J Anaesthesiol. 2021 May 1;38(5):452-458. doi: 10.1097/EJA.0000000000001387.'}]}, 'descriptionModule': {'briefSummary': 'Lung recruitment maneuver induces a decrease in stroke volume, which is more pronounced in hypovolemic patients. The authors hypothesized that the changes of dynamic variables through lung recruitment maneuver could predict preload responsiveness in pediatric patients with lung protective ventilation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pediatric patients undergoing general anesthesia under 6 years old\n\nExclusion Criteria:\n\n* arrhythmia\n* \\<30%, ejection fraction\n* lung disease'}, 'identificationModule': {'nctId': 'NCT03184961', 'briefTitle': 'Lung Recruitment Maneuver for Predicting Fluid Responsiveness in Children', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Study on Variables Able to Predict Fluid Responsiveness Using Lung Recruitment Maneuver in Pediatric Patients Undergoing General Anesthesia', 'orgStudyIdInfo': {'id': 'H1704-042-836'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lung recruitment maneuver', 'description': 'Heart rate, mean arterial pressure, stroke volume, pulse pressure variations, pleth variability index, and photoplethysmographic waveform were recorded before lung recruitment maneuver (application of continuous positive airway pressure of 25 cm H2O for 20 s), during lung recruitment maneuver when stroke volume reached its minimal value.\n\nCardiac index measured before and after volume expansion (10ml/kg saline, 0.9%, infused during 10 min). Patients were considered as responders to fluid administration if cardiac index increased greater than or equal to 15%.', 'interventionNames': ['Diagnostic Test: lung recruitment maneuver']}], 'interventions': [{'name': 'lung recruitment maneuver', 'type': 'DIAGNOSTIC_TEST', 'description': 'Lung recruitment maneuver (application of continuous positive airway pressure of 25 cm H2O for 20 s)', 'armGroupLabels': ['lung recruitment maneuver']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', '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': 'professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}