Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT04469751
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2020-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlation Between Dorsalis Pedis and Radial Arterial Invasive Blood Pressures During Anesthesia Induction in Neurosurgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-11', 'studyFirstSubmitDate': '2020-07-05', 'studyFirstSubmitQcDate': '2020-07-11', 'lastUpdatePostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DPA-RA invasive blood pressure', 'timeFrame': 'During anesthesia induction', 'description': 'All DPA-RA blood pressure dates are Separate analyzed in the following three intervals: Group1 (RASBP 90-109mmHg), Group1 (RASBP 110-129mmHg), Group1 (RASBP 130-149mmHg).The correlation and consistency of each group were analyzed'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['correlation radial artery dorsalis pedis artery'], 'conditions': ['Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '26694940', 'type': 'BACKGROUND', 'citation': 'Chen Y, Cui J, Sun JJ, Wang E, Zhu Y, Li Y, Lu K. Gradient between dorsalis pedis and radial arterial blood pressures during sevoflurane anaesthesia: A self-control study in patients undergoing neurosurgery. Eur J Anaesthesiol. 2016 Feb;33(2):110-7. doi: 10.1097/EJA.0000000000000295.'}, {'pmid': '26484744', 'type': 'BACKGROUND', 'citation': 'Chen Y, Wang E, Zhu Y, Li Y, Lu K. Dorsalis pedis arterial pressure is lower than noninvasive arm blood pressure in normotensive patients under sevoflurane anesthesia. Blood Press Monit. 2016 Feb;21(1):27-32. doi: 10.1097/MBP.0000000000000153.'}]}, 'descriptionModule': {'briefSummary': 'Anesthesiologists need to understand the specific difference between dorsalis pedis arterial(DPA) pressure and the more commonly used radial arterial(RA) pressure When blood pressure monitoring at DPA. Generally, the systolic blood pressure measured in DPA is significantly higher than that in RA, with little difference of diastolic blood pressure and mean artery pressure in two sites. However, there is no specific study on the difference between them, and it is not clear how the diagnosis and treatment threshold should be adjusted when relying on DPA blood pressure measurement to guide treatment. The intraoperative blood pressure of patients is in the normal range in most cases. The purpose of this study is to analyze the correlation of different blood pressure stratification (RASBP90-109mmHg,110-129mmHg,130-149mmHg) of DPA-RA in the normal range to understand the correlation of DPA-RA in different blood pressure ranges, to provide a reference for clinical decision-making and hemodynamic management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients who underwent neurosurgery,American Society of Anesthesiologists' physical status 1-3, BMI 18-24 kg/m², a clinical need for invasive arterial pressure monitoring in the supine position.\n\nExclusion Criteria:\n\n* Arterial puncture site injury or infection,heart failure, severe arrhythmia, congenital heart disease, hypertension, diabetes,preoperative use of dehydration, and intracranial hypertension drugs such as mannitol, peripheral and macrovascular diseases, chronic lung disease, history of heart or lung surgery, The Allens test was positive."}, 'identificationModule': {'nctId': 'NCT04469751', 'briefTitle': 'Correlation Between Dorsalis Pedis and Radial Arterial Invasive Blood Pressures During Anesthesia Induction in Neurosurgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Ningxia Medical University'}, 'officialTitle': 'Correlation Between Dorsalis Pedis and Radial Arterial Invasive Blood Pressures During Anesthesia Induction in Neurosurgical Patients A Self-control Study', 'orgStudyIdInfo': {'id': '2020-511'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients undergoing neurosurgery', 'description': 'radial artery and dorsalis pedis artery intubated with BD Insyte-W 22G artery puncture needle under local anaesthesia', 'interventionNames': ['Diagnostic Test: invasive blood pressure monitoring']}], 'interventions': [{'name': 'invasive blood pressure monitoring', 'type': 'DIAGNOSTIC_TEST', 'description': 'radial artery and dorsalis pedis artery intubated with BD Insyte-W 22G artery puncture needle under local anaesthesia', 'armGroupLabels': ['patients undergoing neurosurgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '750004', 'city': 'Yinchuan', 'state': 'Ningxia', 'country': 'China', 'facility': 'General Hospital of Ningxia Medical University', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Ningxia Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}