Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2026-02-28 @ 8:32 PM
Study NCT ID:
NCT03660306
Status:
COMPLETED
Last Update Posted:
2019-12-03
First Post:
2018-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of OFA During LPV on Postoperative Oxygen Saturation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-01', 'studyFirstSubmitDate': '2018-09-04', 'studyFirstSubmitQcDate': '2018-09-04', 'lastUpdatePostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oxygen requirement post operative to maintain saturation above 94%', 'timeFrame': 'first 24 hours post operative', 'description': 'oxygen saturation'}], 'secondaryOutcomes': [{'measure': 'postoperative pain', 'timeFrame': 'first 24 hours post operative', 'description': 'postoperative pain measured by VAS score'}, {'measure': 'postoperative opioid consumption', 'timeFrame': 'first 24 hours post operative', 'description': 'postoperative opioid consumption measured by morphine equivalents'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Decreased Lung Compliance', 'Oxygen Requirement']}, 'descriptionModule': {'briefSummary': 'Opioids used intra operative increase the amount of opioids needed post operative to control post operative pain. if opioids are given post operative, we assume that more atelectasis and hypoxia takes place even after lung protective ventilation. These postoperative lower oxygen saturations will require giving more frequent oxygen therapy.', 'detailedDescription': 'This is an observational study where the attending anesthesiologist decides to use opioid free or opioid general anesthesia based on his/her expertise.\n\nEvery patient gets a lung protective ventilation and emergence from anesthesia using the principles set forward in the consensus meeting by Young C BJA 2019.\n\nA lung recruitment followed by high PEEP is given when lung compliance decreases below 40 ML/cmH20. The lowest oxygen saturation without adding oxygen therapy is noted post extubation at moment of admission in PACU, after having given an opioid as analgesic and at moment of discharge from PACU..\n\nIf post operative satuation drops below 94% oxygen therapy is given and noted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Major surgery requiring intubation and mechanical ventilation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* major surgery where intubation with mechanical ventilation is required\n* obese patients with BMI \\> 35\n\nExclusion Criteria:\n\n* spontaneous breathing during procedure\n* allergic to any of the drugs used in both groups\n* severe liver, renal, cardiac or pulmonary disease'}, 'identificationModule': {'nctId': 'NCT03660306', 'briefTitle': 'Impact of OFA During LPV on Postoperative Oxygen Saturation', 'organization': {'class': 'OTHER', 'fullName': 'AZ Sint-Jan AV'}, 'officialTitle': 'Observational Study Evaluating the Impact of Opioid Free Anesthesia During Lung Protective Ventilation on Postoperative Oxygen Saturation.', 'orgStudyIdInfo': {'id': 'OS impact OFA on SAT d LPV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'opioid anesthesia', 'description': 'classical anesthesia using sufentanil to block sympathetic reactions during surgery. This decision is based on the anesthesiologist experience and not determined by the patient or procedure.', 'interventionNames': ['Procedure: opioid anesthesia']}, {'label': 'opioid free anesthesia', 'description': 'anesthesia using non opioids like dexmedetomidine, lidocaine, magnesium and ketamine to block sympathetic reactions during surgery. This decision is based on the anesthesiologist experience and not determined by the patient or procedure.', 'interventionNames': ['Procedure: opioid free anesthesia']}], 'interventions': [{'name': 'opioid anesthesia', 'type': 'PROCEDURE', 'description': 'opioid anesthesia means using sufentanil during surgery', 'armGroupLabels': ['opioid anesthesia']}, {'name': 'opioid free anesthesia', 'type': 'PROCEDURE', 'description': 'opioid free anesthesia means giving no opioids during surgery', 'armGroupLabels': ['opioid free anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'Azsintjan', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}], 'overallOfficials': [{'name': 'Marco Lanckneus, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AZ Sint-Jan AV'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AZ Sint-Jan AV', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Jan Mulier', 'investigatorAffiliation': 'AZ Sint-Jan AV'}}}}