Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-04 @ 11:10 PM
Study NCT ID:
NCT04459533
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2020-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sparing in Neuromuscular Blockade in COVID 19 ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-03', 'studyFirstSubmitDate': '2020-06-22', 'studyFirstSubmitQcDate': '2020-07-03', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NMB agents consumption', 'timeFrame': 'ICU discharge an average of 4 weeks', 'description': "We measured the total NMB agents consumption during the stay: cisatracurium and/or atracurium (milligram). Nurses report continuous infusion rates of NMB agents. By extracting this data we were able to retrieve the total approximate dose (we're missing the bolus doses)."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neuromuscular blockade agent', 'neuromuscular blockade monitor', 'Train of Four (TOF)', 'critical illness', 'COVID 19'], 'conditions': ['Neuromuscular Blockade', 'Human Characteristics', 'Complication of Medical Care', 'Intensive Care Unit Acquired Weakness']}, 'descriptionModule': {'briefSummary': 'This is a retrospective case-controlled study of the effect of the use of a neuromuscular blockade (NMB) monitor on the consumption of NMB agents in patients under mechanical ventilation in the context of COVID-19.\n\nThe use of NMB agents during mechanical ventilation in patients with acute respiratory distress syndrome (ARDS) improves respiratory support conditions and reduces mortality. In the context of COVID-19 pandemic, patients with severe forms of the disease hospitalized in intensive care units (ICU) benefit from prolonged mechanical ventilation with frequent use of NMB agents. Large amount of such patient admitted in a short time has led to a shortage of NMB agents, particularly cisatracurium.\n\nThe use of NMB monitors (for example - Train of Four (TOF)) is a well-established practice in general anesthesia. There is no recommendation for the use of NMB monitor in ICU patients available up to date. However, in the attempt to reduce the consumption of NMB agents a NMB monitoring was used in ICU patients during the COVID-19 pandemic at university hospitals of Hospices Civil de Lyon, with the endorsement of the local College of Anesthetists.\n\nThe aim of our study is to evaluate if the use of a NMB monitor decreases the consumption of NMB agents in patients under mechanical ventilation in the context of COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We included all COVID patients in ICU university hospitals in Lyon who required mechanical ventilation and NMB for at least 48 hours.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PCR-proven SARS-CoV-2 infection\n* Use of VM (mechanical ventilation)\n* Use of NMB agents for at least 48 hours\n\nExclusion Criteria:\n\n* Pregnancy\n* extracorporeal membrane oxygenation (ECMO)'}, 'identificationModule': {'nctId': 'NCT04459533', 'acronym': 'TOF-COVID', 'briefTitle': 'Sparing in Neuromuscular Blockade in COVID 19 ICU', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'The Use of Neuromuscular Blockade Monitor as a Strategy for Neuromuscular Blockade Agents Saving in ICU COVID-19 Patients', 'orgStudyIdInfo': {'id': '2020_TOF-COVID'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TOF group', 'description': 'COVID-19 patients admitted to the ICU, receiving mechanical ventilation and NMB agents, for whom a NMB monitor use (TOF) was reported in the electronic health records (EHR).', 'interventionNames': ['Device: TOF protocol']}, {'label': 'Control group', 'description': 'COVID-19 patients admitted to the ICU, receiving mechanical ventilation and NMB agents, with no NMB monitor use reported in the EHR'}], 'interventions': [{'name': 'TOF protocol', 'type': 'DEVICE', 'description': 'To the introduction of CISATRACURIUM, Initial bolus was at 0.2mg/kg and initial continuous infusion at 0.18mg/kg/h of theoretical ideal weight.\n\nTo the introduction of ATRACURIUM, initial bolus was at 0.5mg/kg and initial continuous infusion at 0.5mg/kg/h of theoretical ideal weight.\n\nIntroduction of NMBA was associated to deep sedation (RASS - 4 or RAMSAY 6; BIS 40 to 60).\n\nTOF was measured through the electric stimulation of peripheral nerves (facial or ulnar nerve).\n\nThe dose of NMB agents was then adapted according to the number of answers to the TOF, per 4 hours:\n\n* If 0 response and no respiratory asynchrony: no change in flow rate\n* If \\>=1 or respiratory asynchrony: increase of the continuous curare flow by 20% preceded by a bolus identical to the one administered at the beginning of NMB agent, then recheck at H+1.', 'armGroupLabels': ['TOF group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Department of Anesthesiology and Intensive Care Medicine, Hôpital de la Croix Rousse, Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}