Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-03 @ 12:24 PM
Study NCT ID:
NCT03661502
Status:
UNKNOWN
Last Update Posted:
2019-05-29
First Post:
2018-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Variable Volume Ventilation on Lung Compliance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055370', 'term': 'Lung Injury'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D013898', 'term': 'Thoracic Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-27', 'studyFirstSubmitDate': '2018-09-04', 'studyFirstSubmitQcDate': '2018-09-05', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of lung recruitments required to keep dynamic lung compliance above 40.', 'timeFrame': 'during mechanical ventilation under general anesthesia between 1 and 3 hours. No outcome measurements are measured after 3 hours.', 'description': 'Measuring dynamic lung compliance during mechanical ventilation. When it drops below 40 a lung recruitment is done with increase of PEEP to maximum 15 cmH2O.'}], 'secondaryOutcomes': [{'measure': 'Oxygen saturation at arrival of PACU without oxygen therapy.', 'timeFrame': 'during stay in PACU being between 1 and 4 hours post operative of the same day. No outcome measurements are measured after 4 hours.', 'description': 'oxygen saturation on arrival of PACU without giving oxygen I measured and compared between both groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Injury']}, 'descriptionModule': {'briefSummary': 'Randomized controlled trial comparing low inspiratory and expiratory flow during variable volume ventilation with a constant volume decelerating flow (pressure controlled volume guarantee) ventilation.', 'detailedDescription': 'Randomized controlled trial comparing low inspiratory and expiratory flow during variable volume ventilation (VVV) with a constant volume decelerating flow (PCV pressure controlled volume guarantee) ventilation.\n\nAfter anesthesia induction patients are VVV or PCV ventilated with a positive end expiratory pressure (PEEP) of 10 cm H2O. Average tidal volume is set at 6 ml/kg and end tidal CO2 is kept between 30 and 50 mmHg in both groups by adapting breaths per minute between 10 and 16. I/E ratio is set at 1/1 in VVV and at the standard ½ in PCV.\n\nDynamic lung compliance is measured before and during pneumoperitoneum. If dynamic lung compliance is less than 40 or decreases below 40 a first lung recruitment (10 sec of 30 up to 40 cmH2O) is given till dyn compliance rises above 40.\n\nDynamic lung compliance is further monitored and when value decreases again below 40, a new lung recruitment (LRM) is given and the PEEP is increased to 15 cm H2O after the second LRM.\n\nAll patients get an opioid free general anesthesia with anti inflammatory agents and deep NMB with full reversal at end of surgery.\n\nThe moment and number of LRM performed after induction of anesthesia with the averaged reached lung compliance is used to compare both ventilation methods.\n\nThe oxygen saturation without oxygen at arrival of PACU and the need for oxygen when saturation drops below 95 % are compared between both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* laparoscopic bariatric surgery requiring mechanical ventilation\n\nExclusion Criteria:\n\n* lung disease requiring oxygen before anesthesia\n* emergence procedure\n* spontaneous or assisted ventilation'}, 'identificationModule': {'nctId': 'NCT03661502', 'briefTitle': 'Effect of Variable Volume Ventilation on Lung Compliance', 'organization': {'class': 'OTHER', 'fullName': 'AZ Sint-Jan AV'}, 'officialTitle': 'Effect of Variable Volume Ventilation on Lung Compliance During Mechanical Ventilation.', 'orgStudyIdInfo': {'id': 'JPM 2018 VVV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'variable tidal volume ventilation (VVV)', 'description': 'the intervention is using a ventilation mode with variable tidal volume. The average tidal volume is 6 ml/kg and respiratory rate adapted to reach an end tidalCO2 concentration between 30 and 50 mmHg. Lung recruitment is given when dynamic lung compliance drops below 40. No drug is given. No other treatment or intervention is given.', 'interventionNames': ['Device: VVV']}, {'type': 'EXPERIMENTAL', 'label': 'Pressure controlled ventilation (PCV)', 'description': 'the intervention is using ventilation mode with constant pressure and constant tidal volume. The tidal volume is 6 ml/kg and respiratory rate is adapted to reach end tidal CO2 concentrations between 30 and 50 mmHg. Lung recruitment is given when dynamic lung compliance drops below 40. No drug is given. No other treatment or intervention is given.', 'interventionNames': ['Device: PCV']}], 'interventions': [{'name': 'VVV', 'type': 'DEVICE', 'description': 'ventilation mode with variable tidal volume is chosen. the average tidal volume is 6 ml/kg and respiratory rate adapted to reach end tidal con between 30 and 50 mmHg', 'armGroupLabels': ['variable tidal volume ventilation (VVV)']}, {'name': 'PCV', 'type': 'DEVICE', 'description': 'ventilation mode with constant tidal volume is chosen. the tidal volume is 6 ml/kg and respiratory rate adapted to reach end tidal con between 30 and 50 mmHg', 'armGroupLabels': ['Pressure controlled ventilation (PCV)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'Azsintjan', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}], 'centralContacts': [{'name': 'Jan Paul Mulier', 'role': 'CONTACT', 'email': 'jan.mulier@azsintjan.be', 'phone': '003250452490'}], 'overallOfficials': [{'name': 'Marc Lanckneus', 'role': 'STUDY_CHAIR', 'affiliation': 'AZ Sint-Jan AV'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AZ Sint-Jan AV', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of dep anesthesia & intensive care', 'investigatorFullName': 'Jan Mulier', 'investigatorAffiliation': 'AZ Sint-Jan AV'}}}}