Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-27 @ 10:29 AM
Study NCT ID:
NCT06208592
Status:
COMPLETED
Last Update Posted:
2024-01-26
First Post:
2024-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Anaconda System Use Versus Conventional Sedation in COVID-19 Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'targetDuration': '7 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-24', 'studyFirstSubmitDate': '2024-01-15', 'studyFirstSubmitQcDate': '2024-01-15', 'lastUpdatePostDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intravenous sedation requirements', 'timeFrame': '7 days', 'description': 'Amount of intravenous sedation required'}], 'secondaryOutcomes': [{'measure': 'Delirium', 'timeFrame': 'Hospital stay (up to 30 days)', 'description': 'Number of patients that suffered delirium'}, {'measure': 'Acute kidney injury', 'timeFrame': 'Hospital stay (up to 30 days)', 'description': 'Number of patients that suffered delirium'}, {'measure': 'VAP', 'timeFrame': 'Hospital stay (up to 30 days)', 'description': 'Number of patients that suffered ventilation acquired pneumonia'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sedatives', 'acute kidney injury', 'SARS-CoV-2', 'mechanical ventilation'], 'conditions': ['COVID-19', 'Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'At the beginning of 2020, a global alert emerged which saturated intensive care units due to COVID-19 worldwide. This caused a need for mechanical ventilation due to atypical pneumonias that had a rapid evolution and respiratory failure; therefore the consumption of sedative agents in the intensive care units escalated. Suboptimal sedation in the intensive care unit, increases the adverse effects, costs, and morbidity. For the time being, they focus on the use of intravenous agents such as propofol or dexmedetomidine, which are associated with tolerance, withdrawal, delirium, and hemodynamic effects. Consequently, the need arises to maximize availability and effectiveness, which is why the intervention of the ANACONDA conservation device is carried out, which works with a heat and humidity exchange filter capable of administering isoflurane or sevoflurane with an efficiency of 90%.', 'detailedDescription': 'Analyze the difference in intravenous sedation requirements in patients with COVID-19. Patients who were assisted by a mechanical ventilator with sevoflurane versus conventional sedation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '27 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with confired COVID-19 infection assited with mechanical ventilation that required sedation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with confirmed COVI-19 infection and assited with mechanical ventilation who entered critical care department.\n\nExclusion Criteria:\n\n* Tranfers to a different hospital.\n* Death within the first 24 hours of hospital stay.'}, 'identificationModule': {'nctId': 'NCT06208592', 'briefTitle': 'Comparative Study of Anaconda System Use Versus Conventional Sedation in COVID-19 Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Español de Mexico'}, 'officialTitle': 'Comparative Study of Sedative Requirement Using Sevoflurane With Anaconda Device Versus Conventional Sedation in Patients With COVID-19', 'orgStudyIdInfo': {'id': '2020-01-Anaconda'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anaconda Group', 'description': 'Use of Anaconda devide at any point during the initial follow up (7 days) additional of conventional intravenous sedation', 'interventionNames': ['Device: Sevoflurane with AnaConDa']}, {'label': 'Non-Anaconda Group', 'description': 'Use on conventional intravenous sedation, not using Anaconda device'}], 'interventions': [{'name': 'Sevoflurane with AnaConDa', 'type': 'DEVICE', 'description': 'Sevoflurane administered with AnaConDa device', 'armGroupLabels': ['Anaconda Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76000', 'city': 'Querétaro City', 'state': 'Querétaro', 'country': 'Mexico', 'facility': 'Hospital H+ Queretaro', 'geoPoint': {'lat': 20.58806, 'lon': -100.38806}}], 'overallOfficials': [{'name': 'Manuel Lomeli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital H+ Queretaro'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Available one year after', 'ipdSharing': 'YES', 'description': 'Complete database will be shared as requested by the publishing journal, once the study is apporved.', 'accessCriteria': 'Journal provided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Español de Mexico', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad Nacional Autonoma de Mexico', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Jose J Zaragoza, MD', 'investigatorAffiliation': 'Hospital H+ Queretaro'}}}}