Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-06-02 @ 7:58 PM
Study NCT ID:
NCT01957605
Status:
UNKNOWN
Last Update Posted:
2015-09-30
First Post:
2013-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mean Systemic Pressure Measurement During Prone Position Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-29', 'studyFirstSubmitDate': '2013-10-01', 'studyFirstSubmitQcDate': '2013-10-07', 'lastUpdatePostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean systemic pressure variation', 'timeFrame': 'during surgery after the patient is put in prone position', 'description': 'change of mean systemic pressure from supine position to prone position during surgery'}], 'secondaryOutcomes': [{'measure': 'intrathoracic pressure variation', 'timeFrame': 'during surgery during surgery after the patient is put in prone position', 'description': 'Change of intrathoracic pressure from supine position to prone position during surgery'}, {'measure': 'intravesical pressure variation', 'timeFrame': 'during surgery during surgery after the patient is put in prone position', 'description': 'Change of intravesical pressure from supine position to prone position during surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prone position', 'hemodynamic variation', 'mean systemic pressure'], 'conditions': ['Hemodynamic Variation During Surgery']}, 'descriptionModule': {'briefSummary': 'Venous return is driven by the pressure gradient between mean systemic pressure and right atrial pressure. However, mean systemic pressure is more a physiological concept than an available clinical measurement. Indeed, the mean systemic pressure is the one that would be measured anywhere within the vascular system after cardiac arrest. Recent advances in hemodynamic monitoring have made MSP available to the clinician through beat-by-beat cardiac output measurements during respiratory pauses under mechanical ventilation. In this way, it is possible to calculate MSP, the pressure gradient and the venous return resistances. The investigators aim is to explain the hemodynamic variations and the decrease in cardiac output observed during prone position. The investigators hypothesis is that venous return resistances are increased during prone position probably following an increased intra-abdominal pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient scheduled for neurosurgery in the prone position', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prone position neurosurgery\n* High-risk neurosurgery\n\nExclusion Criteria:\n\n* Emergency surgery\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01957605', 'briefTitle': 'Mean Systemic Pressure Measurement During Prone Position Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Study of Hemodynamic Variations During Prone Position Surgery: Measurement of Mean Systemic Pressure and Venous Return Resistance', 'orgStudyIdInfo': {'id': '5673'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'prone position', 'description': 'Patient scheduled for surgery in the prone position'}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien Pottecher, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Julien Pottecher, MD', 'role': 'CONTACT', 'email': 'julien.pottecher@chru-strasbourg.fr', 'phone': '+33(0)3 88 12 70 95'}], 'overallOfficials': [{'name': 'Julien Pottecher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}