Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-02-24 @ 10:20 PM
Study NCT ID:
NCT04245735
Status:
UNKNOWN
Last Update Posted:
2020-12-01
First Post:
2020-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Perfusion Index in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081282', 'term': 'Perfusion Index'}], 'ancestors': [{'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-30', 'studyFirstSubmitDate': '2020-01-26', 'studyFirstSubmitQcDate': '2020-01-26', 'lastUpdatePostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'perfusion index', 'timeFrame': '6 months', 'description': 'To test the objective role of perfusion index in assessing the success of the peripheral nerve block in children under sedation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Perfusion Index']}, 'referencesModule': {'references': [{'pmid': '28854539', 'type': 'RESULT', 'citation': 'Abdelnasser A, Abdelhamid B, Elsonbaty A, Hasanin A, Rady A. Predicting successful supraclavicular brachial plexus block using pulse oximeter perfusion index. Br J Anaesth. 2017 Aug 1;119(2):276-280. doi: 10.1093/bja/aex166.'}, {'pmid': '23397432', 'type': 'RESULT', 'citation': 'Kus A, Gurkan Y, Gormus SK, Solak M, Toker K. Usefulness of perfusion index to detect the effect of brachial plexus block. J Clin Monit Comput. 2013 Jun;27(3):325-8. doi: 10.1007/s10877-013-9439-4. Epub 2013 Feb 10.'}, {'pmid': '16790660', 'type': 'RESULT', 'citation': 'Galvin EM, Niehof S, Verbrugge SJ, Maissan I, Jahn A, Klein J, van Bommel J. Peripheral flow index is a reliable and early indicator of regional block success. Anesth Analg. 2006 Jul;103(1):239-43, table of contents. doi: 10.1213/01.ane.0000220947.02689.9f.'}, {'pmid': '23055034', 'type': 'RESULT', 'citation': 'Sebastiani A, Philippi L, Boehme S, Closhen D, Schmidtmann I, Scherhag A, Markstaller K, Engelhard K, Pestel G. Perfusion index and plethysmographic variability index in patients with interscalene nerve catheters. Can J Anaesth. 2012 Dec;59(12):1095-101. doi: 10.1007/s12630-012-9796-3. Epub 2012 Oct 2.'}, {'pmid': '24174910', 'type': 'RESULT', 'citation': 'Xu Z, Zhang J, Shen H, Zheng J. Assessment of pulse oximeter perfusion index in pediatric caudal block under basal ketamine anesthesia. ScientificWorldJournal. 2013 Sep 19;2013:183493. doi: 10.1155/2013/183493. eCollection 2013.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of our study is to test the usability of the perfusion index in evaluating the success of the peripheral nerve block applied under sedation in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '60 patients with ASA 1 between the ages 2-10 who will undergo elective upper extremity surgery will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* will undergo elective upper limb surgery,\n* 2- 10 years old,\n* ASA I\n\nExclusion Criteria:\n\n* have regional anesthesia contraindications,\n* allergic to local anesthetics,\n* having an infection at the injection site\n* patients who do not accept the procedure'}, 'identificationModule': {'nctId': 'NCT04245735', 'briefTitle': 'The Role of Perfusion Index in Children', 'organization': {'class': 'OTHER', 'fullName': 'Erzincan University'}, 'officialTitle': 'The Role of Peripheral Perfusion Index in Evaluating the Success of Peripheral Nerve Block in Children Under Sedation', 'orgStudyIdInfo': {'id': 'EBYU PNB CHILDREN'}}, 'armsInterventionsModule': {'interventions': [{'name': 'perfusion index', 'type': 'DIAGNOSTIC_TEST', 'description': 'To test the objective role of perfusion index in assessing the success of the peripheral nerve block in children under sedation.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ILKE KUPELI, MD', 'role': 'CONTACT', 'email': 'ilkeser2004@gmail.com', 'phone': '05555485632'}, {'name': 'ILKE KUPELI', 'role': 'CONTACT', 'email': 'ilkeser2004@gmail.com', 'phone': '05555485632'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erzincan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Derince Training and Research Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assoc. prof.', 'investigatorFullName': 'İLKE KÜPELİ', 'investigatorAffiliation': 'Derince Training and Research Hospital'}}}}