Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-14 @ 4:04 AM
Study NCT ID:
NCT02541656
Status:
COMPLETED
Last Update Posted:
2018-12-13
First Post:
2015-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Preload Dependence Indices in Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011027', 'term': 'Pneumoperitoneum'}], 'ancestors': [{'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-12', 'studyFirstSubmitDate': '2015-07-10', 'studyFirstSubmitQcDate': '2015-09-02', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the validity of pulse pressure variation (in %)', 'timeFrame': 'at Day 0', 'description': 'Performing a fluid challenge after pneumoperitoneum insufflation, the association between pulse pressure variation value and stroke volume variation will be performed.\n\nResponder patients are defined by stroke volume augmentation \\> 15 %'}], 'secondaryOutcomes': [{'measure': 'Threshold value to predict fluid response in laparoscopic conditions.', 'timeFrame': 'at Day 0', 'description': 'A fluid challenge is performed after pneumoperitoneum insufflation to assess the fluid response and calculate the threshold value of fluid response.'}, {'measure': 'Effect of the pneumoperitoneum insufflation on the preload dependence indices : plethysmographic waveform of pulse oximetry variation .', 'timeFrame': 'at Day 0', 'description': 'The measures are performed after applying patient positioning which modify preload conditions. These measures are repeated before and after pneumoperitoneum insufflation and the values of each indices are compared.'}, {'measure': 'Effect of the pneumoperitoneum insufflation on the preload dependence indices : stroke volume variation .', 'timeFrame': 'at Day 0', 'description': 'The measures are performed after applying patient positioning which modify preload conditions. These measures are repeated before and after pneumoperitoneum insufflation and the values of each indices are compared.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preload dependence indices', 'pulse pressure variation', 'plethysmographic waveform of pulse oximetry variation', 'stroke volume variation', 'laparoscopy', 'pneumoperitoneum'], 'conditions': ['Laparoscopic Surgery']}, 'descriptionModule': {'briefSummary': 'A goal-directed fluid management is definitely beneficial in high risk surgery. The fluid administration can be directed by cardiac output monitoring which evaluate the response to repeated fluid challenge or by preload dependence indices. These indices are not well validated in laparoscopic surgery while pneumoperitoneum can alter venous return or pulmonary compliance.\n\nThe aim of the study is to study the validity of pulse pressure variation to predict fluid response under laparoscopic conditions and to describe the effect of the pneumoperitoneum on the dynamic preload indicators, i.e. the pulse pressure variation, the plethysmographic waveform of pulse oximetry variation and the stroke volume variation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Need to laparoscopic colectomy or hepatic resection\n* Written informed consent\n\nExclusion Criteria:\n\n* Cardiac arrhythmia\n* Esophageal and cervical pathologies\n* Radial artery Allen test negative\n* Allergy to anesthesic treatment, to egg or soja\n* Severe kidney failure (estimated glomerular filtration rate \\< 30 ml/min)\n* Age \\< 18 years old\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02541656', 'acronym': 'VPP Coelio', 'briefTitle': 'Dynamic Preload Dependence Indices in Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Dynamic Preload Dependence Indices in Laparoscopic Surgery', 'orgStudyIdInfo': {'id': '2014-879'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'preloaddependence indice after volume expansion in laparoscopy', 'description': 'The measurements of pulse pressure variation, plethysmographic waveform of pulse oximetry variation and stroke volume variation will be performed before pneumoperitoneum at the beginning of the surgery, and will be repeated after pneumoperitoneum insufflation applying each time modification of preload conditions (applying reverse Trendelenburg position followed by Trendelenburg position). The responses will be appreciated by the measurements of the stroke volume.', 'interventionNames': ['Procedure: Study of preload dependence indices after volume expansion in laparoscopy with Saldinger technique.']}], 'interventions': [{'name': 'Study of preload dependence indices after volume expansion in laparoscopy with Saldinger technique.', 'type': 'PROCEDURE', 'description': 'The measurements of pulse pressure variation, plethysmographic waveform of pulse oximetry variation and stroke volume variation will be performed before pneumoperitoneum at the beginning of the surgery, and will be repeated after pneumoperitoneum insufflation applying each time modification of preload conditions (applying reverse Trendelenburg position followed by Trendelenburg position). The responses will be appreciated by the measurements of the stroke volume.', 'armGroupLabels': ['preloaddependence indice after volume expansion in laparoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69002', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}