Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-02-24 @ 10:52 AM
Study NCT ID:
NCT03220906
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2017-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Blood Pressure Measurements in Upper and Lower Extremities in Children Under General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-30', 'studyFirstSubmitDate': '2017-07-14', 'studyFirstSubmitQcDate': '2017-07-14', 'lastUpdatePostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Deviation >5 mmHg in MAP', 'timeFrame': '45 minutes', 'description': 'Deviation \\>5 mmHg in MAP between one of the non-invasive measurements compared to invasive BP measurement at any point during the study.'}], 'secondaryOutcomes': [{'measure': 'Deviation >10 mmHg', 'timeFrame': '45 minutes', 'description': 'Deviation \\>10 mmHg between the non-invasive and invasive measurements.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery']}, 'descriptionModule': {'briefSummary': 'There is very little information comparing non-invasive blood pressure (BP) readings obtained from upper and lower limbs, as well as comparing invasive and non-invasive blood pressures in the children under anesthesia. This study seeks to determine the correlation between the non-invasive BP measurements between upper and lower extremities and compare these measurements with the invasive BP as the standard for comparison.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Children undergoing a surgical procedure with planned arterial cannula placement at Nationwide Children's Hospital in Columbus, OH or King Fahad Medical City in Riyadh, Saudi Arabia.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA status 1-3\n* 0-10 years of age\n* Undergoing surgical procedure with planned arterial cannula placement\n\nExclusion Criteria:\n\n* ASA status \\>3\n* Older than 10 years of age\n* Patient unable to have BP taken on 1 upper and 1 lower extremity'}, 'identificationModule': {'nctId': 'NCT03220906', 'briefTitle': 'Comparison of Blood Pressure Measurements in Upper and Lower Extremities in Children Under General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Comparison of Blood Pressure Measurements in Upper and Lower Extremities in Children Under General Anesthesia', 'orgStudyIdInfo': {'id': 'IRB17-00268'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arterial line', 'description': 'Children undergoing surgical procedure with planned arterial cannula placement.', 'interventionNames': ['Other: Blood pressure measurement']}], 'interventions': [{'name': 'Blood pressure measurement', 'type': 'OTHER', 'description': 'Blood pressure will be measured in both upper and lower extremities.', 'armGroupLabels': ['Arterial line']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'King Fahad Medical City', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman, Dept. of Anesthesiology & Pain Medicine', 'investigatorFullName': 'Joseph D. Tobias', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}