Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-02-22 @ 7:26 PM
Study NCT ID:
NCT02908256
Status:
COMPLETED
Last Update Posted:
2018-01-19
First Post:
2016-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Intraoperative Volume Replacement Determined by the Plethysmograph Variability Index (PVI) With That Determined by the Delta PP in the Digestive, Gynecological, Urological, and Abdominal Surgery and Their Impact on the Length of Stay
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-18', 'studyFirstSubmitDate': '2016-09-16', 'studyFirstSubmitQcDate': '2016-09-19', 'lastUpdatePostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'average of 5 days'}], 'secondaryOutcomes': [{'measure': 'EVA score', 'timeFrame': 'up to 72 hours', 'description': 'post surgery pain scoring'}, {'measure': 'number of anti-emetics administered', 'timeFrame': 'up to 72 hours'}, {'measure': 'length of stay in recovery room', 'timeFrame': 'up to 24 hours'}, {'measure': 'First time up', 'timeFrame': 'up to 72 hours', 'description': 'First time up/ first time sitting in a chair'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PVI', 'delta PP', 'vascular filling'], 'conditions': ['Abdomino-pelvic Surgery']}, 'referencesModule': {'references': [{'pmid': '17390421', 'type': 'BACKGROUND', 'citation': 'Bundgaard-Nielsen M, Holte K, Secher NH, Kehlet H. Monitoring of peri-operative fluid administration by individualized goal-directed therapy. Acta Anaesthesiol Scand. 2007 Mar;51(3):331-40. doi: 10.1111/j.1399-6576.2006.01221.x.'}, {'pmid': '19602972', 'type': 'BACKGROUND', 'citation': 'Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.'}, {'pmid': '18522935', 'type': 'BACKGROUND', 'citation': 'Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. Pleth variability index to monitor the respiratory variations in the pulse oximeter plethysmographic waveform amplitude and predict fluid responsiveness in the operating theatre. Br J Anaesth. 2008 Aug;101(2):200-6. doi: 10.1093/bja/aen133. Epub 2008 Jun 2.'}, {'pmid': '20035228', 'type': 'BACKGROUND', 'citation': 'Zimmermann M, Feibicke T, Keyl C, Prasser C, Moritz S, Graf BM, Wiesenack C. Accuracy of stroke volume variation compared with pleth variability index to predict fluid responsiveness in mechanically ventilated patients undergoing major surgery. Eur J Anaesthesiol. 2010 Jun;27(6):555-61. doi: 10.1097/EJA.0b013e328335fbd1.'}, {'pmid': '17521454', 'type': 'BACKGROUND', 'citation': 'Michard F, Lopes MR, Auler JO Jr. Pulse pressure variation: beyond the fluid management of patients with shock. Crit Care. 2007;11(3):131. doi: 10.1186/cc5905.'}, {'pmid': '30851740', 'type': 'DERIVED', 'citation': 'Coeckelenbergh S, Delaporte A, Ghoundiwal D, Bidgoli J, Fils JF, Schmartz D, Van der Linden P. Pleth variability index versus pulse pressure variation for intraoperative goal-directed fluid therapy in patients undergoing low-to-moderate risk abdominal surgery: a randomized controlled trial. BMC Anesthesiol. 2019 Mar 9;19(1):34. doi: 10.1186/s12871-019-0707-9.'}]}, 'descriptionModule': {'briefSummary': 'An optimal intraoperative fluid replacement reduces the hospital stay, the admissions in the intensive care unit and the mortality rate after a major surgery.\n\nDifferent criteria are used to guide the optimal vascular filling of a patient. Among the various monitoring for the last twenty years are parameters originating from the respiratory variations of the arterial pressure curves and the pulse oximetry.\n\nOn arterial curves, the Systolic Pressure Variation (SPV) is the difference between the maximum systolic pressure (DeltaUp) and the minimal one (DeltaDown).On the oxygen saturometry curves obtained with the Masimo Radical7, the plethysmographic variability index (PVI) corresponds to the formula (PImax-PImin/PImax X 100%) where PI corresponds to the quotient expressed in % between the pulsed infrared absorption signal and the continuous absorption signal.\n\nIt has been demonstrated that the dynamic indexes were better than the static indexes to determine the response to the vascular filling. A meta-analysis showed that the dynamic changes of the variables derived from the arterial pressure curve of patients under mechanic ventilation could predict the vascular filling responsiveness with a high specificity and sensibility. The same thing applies to the variables derived from the pulsed oxymetry curves.\n\nFurthermore, monitoring and minimizing, through the vascular filling, the variations of the pulsated arterial pressure (delta PP) induced by the mechanic ventilation during a high risk surgery allows to reduce the postoperative complications and the hospital length of stay. This has not yet been proved for the non invasive parameters (IP and PVI).\n\nThe goal of this study is thus to compare a non invasive strategy (based on PVI) to an invasive strategy (based on the deltaPP) of perioperatory filling during abdomino-pelvic interventions (digestive, gynecologic, urologic), in order to test their equivalence and measure their impact in terms of hospital stay.\n\nThis record is linked to the NCT02709252 record and share the same cohort of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Abdominal-pelvic surgery (digestive, gynecologic, urologic) with laparotomy or laparoscopy\n* Surgery duration superior to 1 hour\n\nExclusion Criteria:\n\n* ASA score of 4\n* BMI \\> 35\n* supraventricular arrythmia (isolated extrasystoles excepted)\n* cardiac insufficiency (F.E \\< 25 %)\n* severe peripheric vascular affections\n* severe respiratory affections\n* terminal renal insufficiency (creatine clear and \\< 30 mL/min)\n* gelatin allergies'}, 'identificationModule': {'nctId': 'NCT02908256', 'briefTitle': 'Comparison of Intraoperative Volume Replacement Determined by the Plethysmograph Variability Index (PVI) With That Determined by the Delta PP in the Digestive, Gynecological, Urological, and Abdominal Surgery and Their Impact on the Length of Stay', 'organization': {'class': 'OTHER', 'fullName': 'Brugmann University Hospital'}, 'officialTitle': 'Randomized Double-blind Comparison of Intraoperative Volume Replacement Determined by the Plethysmograph Variability Index (PVI) With That Determined by the Delta PP in the Digestive, Gynecological, Urological, and Abdominal Surgery and Their Impact on the Length of Stay', 'orgStudyIdInfo': {'id': 'CHUB-GIFA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PVI group', 'description': 'Monitoring of the PVI during the surgical intervention', 'interventionNames': ['Drug: Geloplasma (PVI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delta PP group', 'description': 'Monitoring of the deltaPP during the surgical intervention', 'interventionNames': ['Drug: Geloplasma (delta PP)']}], 'interventions': [{'name': 'Geloplasma (PVI)', 'type': 'DRUG', 'description': 'In the PVI group, a filling solution (geloplasma) will be given as a bolus of 250 ml administered in 10 minutes if the PVI\\>15% during more than 5 minutes. The bolus will be repeated if the PVI remains over 15%.', 'armGroupLabels': ['PVI group']}, {'name': 'Geloplasma (delta PP)', 'type': 'DRUG', 'description': 'In the delta PP group, a filling solution (geloplasma) will be given as a bolus of 250 ml administered in 10 minutes if the delta PP\\> 13% during more than 5 minutes. The bolus will be repeated if the delta PP remains over 13%.', 'armGroupLabels': ['Delta PP group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Philippe Van Der Linden, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Brugmann'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brugmann University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of clinic', 'investigatorFullName': 'Philippe VAN DER LINDEN', 'investigatorAffiliation': 'Brugmann University Hospital'}}}}