Nctid:
NCT06230653
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"OTHER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>40}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-01-22", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-04-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-19", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-04-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Tetanic fade", "timeFrame"=>"intraoperative", "description"=>"Measurement of the tetanic fading at baseline, at a TOF ratio of 0.9 measured by EMG, at a TOF ratio of 0.95 measured by EMG, and 5 min after a bolus of 2 mg/kg sugammadex"}], "primaryOutcomes"=>[{"measure"=>"Precision of the Mechanomyography", "timeFrame"=>"intraoperative", "description"=>"Measured by the repeatability coefficient at baseline and at complete neuromuscular recovery"}], "secondaryOutcomes"=>[{"measure"=>"Agreement of the TOF ratio between Electromyography and Mechanomyography", "timeFrame"=>"intraoperative", "description"=>"Agreement of the TOF ratio at 7 predefined TOF ratios: 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, and 0.9"}, {"measure"=>"Confirmation of handling and precision of Mechanomyography sensor", "timeFrame"=>"intraoperative", "description"=>"Investigation of baseline stability (i.e., no staircase phenomenon of the first twitch response and the TOF ratio), occurrence and magnitude of idiosyncratic TOF ratio \\> 1.0 during baseline measurement, repeatability of the TOF ratio during recovery from a rocuronium induced neuromuscular blockade, and sensitivity of the TOF ratio to changing the hand position during baseline measurements."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Mechanomyography", "Neuromuscular Blockade", "Electromyography", "Tetanic fading"], "conditions"=>["Neuromuscular Blockade"]}, "descriptionModule"=>{"briefSummary"=>"Neuromuscular monitoring is used to evaluate neuromuscular function intraoperatively and to ensure complete neuromuscular recovery at the end of anaesthesia. Therefore, the lack of reliable neuromuscular monitoring devices that are not cumbersome to use is a major shortcoming for anaesthesia. A recently developed mechanomyography (MMG) device may meet these partially unmet needs due to its measurement of the patient's contractile force instead of its surrogates (i.e., acceleration, velocity), including the response to physiologically relevant tetanic stimulation. However, it is unclear whether the reliability of the newly developed MMG device is similar to or better than the currently available gold standard of neuromuscular monitoring based on electromyography (EMG).", "detailedDescription"=>"The MEMORY trial is a randomized clinical agreement study which will prospectively enrol thirty ASA 1 or 2 patients ≥ 18 years scheduled for non-cardiac surgery requiring general anaesthesia and neuromuscular blockade for optimisation of surgical conditions. The patient's neuromuscular function is measured on one hand with MMG and the other hand with EMG in a randomised fashion. Additionally, randomisation will be stratified the domination of one hand.\n\nIn the MEMORY trial we will test the hypothesis, that a newly developed MMG sensor provides not less reliable measurements of neuromuscular function compared to EMG in adult patients. Reliability includes agreement, precision, and the absence of staircase phenomenon and idiosyncratic responses to train-of-four (TOF) stimulation. In addition, we will explore if measurement of tetanic fade will provide more precise information about complete neuromuscular recovery than the current standard of TOF ratio \\>0.9."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"The MEMORY trial is a randomized clinical agreement study which will prospectively enrol adult ASA 1 or 2 patients scheduled for non-cardiac surgery requiring general anaesthesia and neuromuscular blockade for optimisation of surgical conditions.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* age ≥ 18 years\n* ASA \\< 3\n* scheduled for non-cardiac surgery requiring general anaesthesia and neuromuscular blockade for optimisation of surgical conditions\n* positioning during surgery with intraoperative access to both arms\n\nExclusion Criteria:\n\n* allergy to muscle relaxants and reversal agents\n* neuromuscular disease\n* procedure is scheduled outside the operating room\n* need of endotracheal intubation prior to surgery\n* need of rapid sequence induction\n* pregnancy, breastfeeding or 30 days postpartum\n* surgical procedure or examination findings which are a contraindication for a supraglottic airway device\n* employee of the investigator or study site directly involved in this study or other studies under the direction of the investigator or study site\n* family member of the investigator\n* custodial accommodation\n* alcohol or drug abuse\n* patients with preceding injuries impairing muscle or nerve function of the arm\n* Participation in other studies with investigational drugs or devices within 4 weeks prior to screening or missing agreement not to participate in any other study at the same time or within a period of one month after the MEMORY study"}, "identificationModule"=>{"nctId"=>"NCT06230653", "acronym"=>"MEMORY", "briefTitle"=>"Mechanomyography Reloaded? A Randomized Prospective Agreement Study", "organization"=>{"class"=>"OTHER", "fullName"=>"University Hospital Ulm"}, "officialTitle"=>"A Single-centre, Randomised, Prospective Agreement Study to Determine the Clinical Performance and Safety of a Best Practice Medical Device With a Novel Sensor", "orgStudyIdInfo"=>{"id"=>"MEMORY"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"MMG on dominant arm", "description"=>"Mechanomyography-device will be examined on the dominant arm."}, {"label"=>"MMG on non-dominant arm", "description"=>"Mechanomyography-device will be examined on the non-dominant arm."}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Anna Scholze", "role"=>"CONTACT", "email"=>"anna.scholze@tum.de", "phone"=>"00498941408974"}], "overallOfficials"=>[{"name"=>"Manfred Blobner, MD PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Department of Anesthesiology and Intensive Care Medicine, Technical University of Munich, Germany"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University Hospital Ulm", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Manfred Blobner", "investigatorAffiliation"=>"University Hospital Ulm"}}}}
