Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2025-12-31 @ 5:06 AM
Study NCT ID:
NCT02907957
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2016-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infrared Thermography for Assessment of Caudal Block in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-16', 'studyFirstSubmitDate': '2016-09-09', 'studyFirstSubmitQcDate': '2016-09-19', 'lastUpdatePostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive value of FLIR ONE', 'timeFrame': 'Assessments will be done through study completion, an average of 1 week following procedure.', 'description': 'Reviewers blinded to intervention groups will asses patient pre-caudal, 1, 2, 3, 4, and 5 minute post-caudal images and rate whether, based on the image, they believe the patient received a caudal or not. The sensitivity and specificity of the FLIR ONE as a diagnositic tol will then be determined.'}], 'secondaryOutcomes': [{'measure': 'Inter- and Intra- rater reliability', 'timeFrame': 'Assessments will be done through study completion, an average of 1 week following procedure.', 'description': 'Reviewers will evaluate patient image at two separate ties at least a week apart. Recorded images will be compared within and between reviewers.'}, {'measure': 'Temperature differences between pre-caudal and 5 minute post-caudal images', 'timeFrame': 'Images will be captured prior to caudal and 5 minutes immediately afterwards. Assessments will be done through study completion, an average of 1 week following procedure.', 'description': 'Temperature differences between pre-caudal and 5 minute images will be summarized in both groups. Images in the non-caudal group will be taken at similar time points following anesthesia induction relative to caudal group patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anesthesia, Conduction']}, 'referencesModule': {'references': [{'pmid': '25393589', 'type': 'BACKGROUND', 'citation': 'Suresh S, Long J, Birmingham PK, De Oliveira GS Jr. Are caudal blocks for pain control safe in children? an analysis of 18,650 caudal blocks from the Pediatric Regional Anesthesia Network (PRAN) database. Anesth Analg. 2015 Jan;120(1):151-156. doi: 10.1213/ANE.0000000000000446.'}]}, 'descriptionModule': {'briefSummary': 'Regional analgesia via caudal neuraxial blockade provides pain relief for pediatric patients following urological and lower extremity procedures. The injection of local anesthetic into the caudal epidural space causes a sensory loss. This sympathetic blockade in turn causes a vasodilation, or increased blood flow, to the lower extremities.\n\nThe purpose of this study is to determine whether the FLIR ONE thermographic camera, a smartphone attachment which utilizes an application ("app") to measure the temperature at a site on an image of the lower extremity, will be able to differentiate between caudal, non-caudal, and failed caudal images.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children from 6mos to 5 years of age requiring general anesthesia and a caudal block for a surgical procedure\n\nExclusion Criteria:\n\n* Patients with preexisting conditions that could affect the skin temperature on the lower extremities such as infection, edema, vascular disorder, etc.\n* American Society of Anesthesiologists comorbidity ranking of 4 or greater\n* Patient with contraindications for a caudal block such as: history of allergic, reactions to local anesthetics, coagulopathy, infection at the injection site, spinal abnormality, peripheral neurological disease, Raynaud's disease"}, 'identificationModule': {'nctId': 'NCT02907957', 'briefTitle': 'Infrared Thermography for Assessment of Caudal Block in Children', 'organization': {'class': 'OTHER', 'fullName': "Ann & Robert H Lurie Children's Hospital of Chicago"}, 'officialTitle': 'A Clinical Evaluation Of Infrared Thermography To Assess Successful Caudal Block In Children', 'orgStudyIdInfo': {'id': 'IRB 2016-590'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Caudal', 'description': 'Participants receiving a caudal neuraxial blockade, as clinically indicated.', 'interventionNames': ['Device: FLIR ONE', 'Procedure: Regional Anesthesia - Caudal Nerve Block']}, {'type': 'SHAM_COMPARATOR', 'label': 'No Caudal', 'description': 'Participants not receiving a caudal neuraxial blockade, as clinically indicated.', 'interventionNames': ['Device: FLIR ONE']}], 'interventions': [{'name': 'FLIR ONE', 'type': 'DEVICE', 'description': 'Thermographic assessment of the lower extremities is obtained using the FLIR ONE smartphone camera and software.', 'armGroupLabels': ['Caudal', 'No Caudal']}, {'name': 'Regional Anesthesia - Caudal Nerve Block', 'type': 'PROCEDURE', 'description': 'Nerve block placement as a pain management strategy indicated for certain urological and lower extremity surgeries.', 'armGroupLabels': ['Caudal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60613', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H. Lurie Children's Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Luis Sequera-Ramos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Ann & Robert H Lurie Children's Hospital of Chicago", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Physician, Anesthesiology', 'investigatorFullName': 'Luis Sequera-Ramos', 'investigatorAffiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}}}}