Nctid:
NCT06224010
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000086382", "term"=>"COVID-19"}, {"id"=>"D000012141", "term"=>"Respiratory Tract Infections"}, {"id"=>"D000012128", "term"=>"Respiratory Distress Syndrome"}, {"id"=>"D000012127", "term"=>"Respiratory Distress Syndrome, Newborn"}, {"id"=>"D000012131", "term"=>"Respiratory Insufficiency"}, {"id"=>"D000055371", "term"=>"Acute Lung Injury"}, {"id"=>"D000053120", "term"=>"Respiratory Aspiration"}], "ancestors"=>[{"id"=>"D000011024", "term"=>"Pneumonia, Viral"}, {"id"=>"D000011014", "term"=>"Pneumonia"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000018352", "term"=>"Coronavirus Infections"}, {"id"=>"D000003333", "term"=>"Coronaviridae Infections"}, {"id"=>"D000030341", "term"=>"Nidovirales Infections"}, {"id"=>"D000012327", "term"=>"RNA Virus Infections"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000012120", "term"=>"Respiration Disorders"}, {"id"=>"D000007235", "term"=>"Infant, Premature, Diseases"}, {"id"=>"D000007232", "term"=>"Infant, Newborn, Diseases"}, {"id"=>"D000055370", "term"=>"Lung Injury"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M14978", "name"=>"Respiratory Tract Infections", "asFound"=>"Respiratory Infection", "relevance"=>"HIGH"}, {"id"=>"M14968", "name"=>"Respiratory Insufficiency", "asFound"=>"Respiratory Failure", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M27137", "name"=>"Respiratory Aspiration", "asFound"=>"Inspiratory", "relevance"=>"HIGH"}, {"id"=>"M14965", "name"=>"Respiratory Distress Syndrome", "asFound"=>"Respiratory Distress Syndrome", "relevance"=>"HIGH"}, {"id"=>"M14964", "name"=>"Respiratory Distress Syndrome, Newborn", "asFound"=>"Respiratory Distress Syndrome", "relevance"=>"HIGH"}, {"id"=>"M2561", "name"=>"COVID-19", "asFound"=>"COVID-19", "relevance"=>"HIGH"}, {"id"=>"M4185", "name"=>"Hypoxia", "relevance"=>"LOW"}, {"id"=>"M28144", "name"=>"Acute Lung Injury", "asFound"=>"Acute Respiratory Distress Syndrome", "relevance"=>"HIGH"}, {"id"=>"M28143", "name"=>"Lung Injury", "relevance"=>"LOW"}, {"id"=>"M13904", "name"=>"Pneumonia", "relevance"=>"LOW"}, {"id"=>"M13914", "name"=>"Pneumonia, Viral", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M20490", "name"=>"Coronavirus Infections", "relevance"=>"LOW"}, {"id"=>"M6555", "name"=>"Coronaviridae Infections", "relevance"=>"LOW"}, {"id"=>"M23685", "name"=>"Nidovirales Infections", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M14957", "name"=>"Respiration Disorders", "relevance"=>"LOW"}, {"id"=>"M25869", "name"=>"Premature Birth", "relevance"=>"LOW"}, {"id"=>"M10279", "name"=>"Infant, Premature, Diseases", "relevance"=>"LOW"}, {"id"=>"M10276", "name"=>"Infant, Newborn, Diseases", "relevance"=>"LOW"}, {"id"=>"T4927", "name"=>"Respiratory Distress Syndrome, Infant", "asFound"=>"Respiratory Distress Syndrome", "relevance"=>"HIGH"}, {"id"=>"T192", "name"=>"Acute Respiratory Distress Syndrome", "asFound"=>"Acute Respiratory Distress Syndrome", "relevance"=>"HIGH"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>56}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2020-11-21", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-06-20", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-23", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-06-01", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Respiratory drive", "timeFrame"=>"90 breaths", "description"=>"Evaluation of respiratory drive using P0.1"}, {"measure"=>"Neuroventilatory coupling", "timeFrame"=>"90 breaths", "description"=>"Evaluation of respiratory drive using EAdi PEAK"}, {"measure"=>"Respiratory effort", "timeFrame"=>"90 breaths", "description"=>"Evaluation of respiratory drive using ∆Pmus-EAdi derived, ∆Pmus-∆Pocc derived, PTP/min"}, {"measure"=>"Transpulmonary driving pressure", "timeFrame"=>"90 breaths", "description"=>"Evaluation of respiratory drive using ∆Plung, dynamic"}], "secondaryOutcomes"=>[{"measure"=>"Composite outcome", "timeFrame"=>"within forty eight hour from assisted spontaneous breathing", "description"=>"Transition from light to deep sedation (Richmond agitation sedation scale from 0/-3 to -4/-5) or from assisted to controlled ventilation within 48 hours of spontaneous assisted breathing"}, {"measure"=>"Intensive care unit mortality", "timeFrame"=>"Intensive care unit stay", "description"=>"Mortality"}, {"measure"=>"Mortality", "timeFrame"=>"60 days after measurement", "description"=>"Mortality"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["ARDS", "COVID-19", "Weaning from mechanical ventilation", "Respiratory drive", "Inspiratory effort", "Respiratory monitoring"], "conditions"=>["ARDS, Human", "COVID-19 Respiratory Infection", "COVID-19 Acute Respiratory Distress Syndrome", "Respiratory Effort-Related Arousal", "Weaning Failure", "Mechanical Ventilation Complication", "Acute Hypoxic Respiratory Failure"]}, "referencesModule"=>{"references"=>[{"pmid"=>"30389829", "type"=>"BACKGROUND", "citation"=>"Bellani G, Bronco A, Arrigoni Marocco S, Pozzi M, Sala V, Eronia N, Villa G, Foti G, Tagliabue G, Eger M, Pesenti A. Measurement of Diaphragmatic Electrical Activity by Surface Electromyography in Intubated Subjects and Its Relationship With Inspiratory Effort. Respir Care. 2018 Nov;63(11):1341-1349. doi: 10.4187/respcare.06176."}, {"pmid"=>"31694692", "type"=>"BACKGROUND", "citation"=>"Bertoni M, Telias I, Urner M, Long M, Del Sorbo L, Fan E, Sinderby C, Beck J, Liu L, Qiu H, Wong J, Slutsky AS, Ferguson ND, Brochard LJ, Goligher EC. A novel non-invasive method to detect excessively high respiratory effort and dynamic transpulmonary driving pressure during mechanical ventilation. Crit Care. 2019 Nov 6;23(1):346. doi: 10.1186/s13054-019-2617-0."}, {"pmid"=>"26728475", "type"=>"BACKGROUND", "citation"=>"Di Mussi R, Spadaro S, Mirabella L, Volta CA, Serio G, Staffieri F, Dambrosio M, Cinnella G, Bruno F, Grasso S. Impact of prolonged assisted ventilation on diaphragmatic efficiency: NAVA versus PSV. Crit Care. 2016 Jan 5;20:1. doi: 10.1186/s13054-015-1178-0."}, {"pmid"=>"33218354", "type"=>"BACKGROUND", "citation"=>"Di Mussi R, Spadaro S, Volta CA, Bartolomeo N, Trerotoli P, Staffieri F, Pisani L, Iannuzziello R, Dalfino L, Murgolo F, Grasso S. Continuous assessment of neuro-ventilatory drive during 12 h of pressure support ventilation in critically ill patients. Crit Care. 2020 Nov 20;24(1):652. doi: 10.1186/s13054-020-03357-9."}, {"pmid"=>"23982026", "type"=>"BACKGROUND", "citation"=>"Vaschetto R, Cammarota G, Colombo D, Longhini F, Grossi F, Giovanniello A, Della Corte F, Navalesi P. Effects of propofol on patient-ventilator synchrony and interaction during pressure support ventilation and neurally adjusted ventilatory assist. Crit Care Med. 2014 Jan;42(1):74-82. doi: 10.1097/CCM.0b013e31829e53dc."}]}, "descriptionModule"=>{"briefSummary"=>"Data comparing respiratory drive and effort in critically ill patients with acute respiratory distress syndrome associated to different severity of COVID-19 penumonia (CARDS) and to other risk factors are lacking. Objectives: To assess respiratory drive and effort of CARDS patients at the first transition from controlled to assisted spontaneous breathing. The second aim was the rate of a composite outcome including the need of higher level of sedation", "detailedDescription"=>"Multicenter cohort study in four Italian ICU including adults with moderate and severe CARDS (PaO2/FiO2 \\<100 mmHg) at ICU admission. An historical cohort of patients with ARDS from various etiologies used for comparison. Respiratory drive (P0.1), diaphragm electrical activity (EAdi), inspiratory effort derived from EAdi (∆PmusEAdi) and from deflection in airway pressure occluded (ΔPocc) (PmusΔPocc), dynamic transpulmonary driving pressure (ΔPL,dyn, the difference between peak and end-expiratory transpulmonary pressure) measured under assisted ventilation.\n\nThe main ventilatory pattern variables:\n\n* Airway Occlusion Pressure (P0.1): Measurement of the decrease in airway pressure during an end-expiratory occlusion.\n* Pmus-EAdi-derived (∆Pmus, EAdi): Measurement of the pressure generated by the respiratory muscles during inspiration derived by electrical activity of the diaphragm measurements.\n* Transpulmonary pressure EAdi-derived (∆Plung,dyn): difference between peak and end-expiratory transpulmonary pressure .\n* Occlusive Pressure Difference (∆Pocc): Evaluation of the pressure difference between the initial and final airway opening during inspiration.\n* Pmus-∆Pocc-derived (∆Pmus, ∆Pocc): Measurement of the pressure generated by the respiratory muscles during inspiration derived by ∆Pocc (∆Pocc\\*0.75)\n* Transpulmonary driving pressure ∆Pocc derived (∆Plung, ∆Pocc): calculated as (Peak airway pressure -PEEP) - 2/3 \\* ∆Pocc\n* Diaphragmatic Electrical Activity (EAdi): Recording of the electrical activity of the diaphragm.\n* Peak EAdi (EAdiPEAK): Determination of the highest recorded value of diaphragmatic electrical activity.\n* Pressure time product of the trans-diaphragmatic pressure per breath and per minute(PTP/min): the integral of Pmusc-EAdi-derived during inspiration per breath.\n* Inspiratory Delay (ID): Assessment of the time delay between the start of neural inspiration and the onset of mechanical ventilation.\n* Neuro-ventilatory Efficiency (NVE): Measurement of the efficiency of the neural drive to the respiratory muscles.\n* Peak Airway Opening Pressure (PawPEAK): Measurement of the peak pressure in the airway during inspiration.\n* Inspiratory Pressure-Time Product (PmusEAdi/b): Calculation of the work of breathing by integrating the product of diaphragmatic electrical activity and the change in airway pressure during inspiration.\n* Tidal Volume (VT): Measurement of the volume of air inspired and expired during each breath.\n* Respiratory Rate: Calculation of the number of breaths per minute delivered by the mechanical ventilator.\n* Inspiratory and Expiratory Time (Ti,MECH and Te,MECH): Determination of the duration of mechanical inspiration and expiration.\n* Inspiratory Duty Cycle (TI/TTOT-neur): Calculation of the ratio of inspiratory time to total respiratory cycle time based on neural inspiration."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients with diagnosis of acute respiratory distress syndrome due to confirmed (real-time RT-PCR on nasopharyngeal swabs, or lower respiratory tract aspirates) COVID-19 (CARDS), had received invasive mechanical ventilation for more than 72 hours and were candidates for assisted ventilation. The CARDS cohort divided into 'Moderate' and 'Severe' COVID groups according to P/F ratio at ICU admission.\n\nA separate cohort of patients with ARDS by etiology different from COVID-19 (No-COVID), enrolled in previous studies and with the same inclusion and exclusion criteria.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients with a diagnosis of acute respiratory distress syndrome based on the Berlin criteria.\n* Patients with ARDS due to confirmed COVID-19 through real-time RT-PCR on nasopharyngeal swabs or lower respiratory tract aspirates.\n* Patients who had received invasive mechanical ventilation for more than 72 hours.\n* Patients who were candidates for assisted ventilation.\n\nReadiness for assisted ventilation, which was defined by the following criteria:\n\n1. Improvement of the condition leading to acute respiratory failure.\n2. Positive end-expiratory pressure lower than 10 cmH2O and inspiratory oxygen fraction lower than 0.5.\n3. Richmond agitation sedation scale score between 0 and -3.\n4. Ability to trigger the ventilator, i.e., decrease pressure airway opening by more than 3-4 cmH2O during a brief (5-10 seconds) end-expiratory occlusion test.\n\n * Hemodynamic stability without vasopressor or inotropes, except for dobutamine and norepinephrine infusion below certain thresholds (dobutamine \\<5 gamma/Kg/min and norepinephrine \\<0.3 gamma/Kg/min).\n * Normothermia.\n\nExclusion Criteria:\n\n* Patients affected by neurological or neuromuscular pathology and/or known phrenic nerve dysfunction.\n* Patients with any contraindication to the insertion of a nasogastric tube, such as recent upper gastrointestinal surgery or esophageal varices.\n* Patients \\< 18 years old"}, "identificationModule"=>{"nctId"=>"NCT06224010", "briefTitle"=>"Respiratory Drive and Inspiratory Effort in COVID-19 Associated ARDS", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Turin, Italy"}, "officialTitle"=>"Respiratory Drive and Inspiratory Effort in COVID-19 Associated ARDS: a Multicentric Prospective Observational Study", "orgStudyIdInfo"=>{"id"=>"CE 0084148"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Non-COVID", "description"=>"* This group includes patients diagnosed with Acute Respiratory Distress Syndrome (ARDS) caused by etiologies other than COVID-19.\n* ARDS was defined following Berlin criteria (2012)", "interventionNames"=>["Other: Respiratory drive and effort assessment"]}, {"label"=>"COVID-Moderate", "description"=>"* Moderate COVID indicates a less severe level of hypoxemia compared to the Severe COVID group (according to Berlin criteria).\n* The moderate COVID group is further characterized by a diagnosis of moderate Acute Respiratory Distress Syndrome (ARDS), based on a P/F ratio (partial pressure of oxygen/fraction of inspired oxygen) at ICU admission.\n* The diagnosis of COVID-19 in these patients was confirmed using the Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) technique.\n* RT-PCR involves collecting a sample from the lower respiratory tract and detecting the presence of SARS-CoV-2 viral RNA.", "interventionNames"=>["Other: Respiratory drive and effort assessment"]}, {"label"=>"COVID-Severe", "description"=>"* The severe COVID group has a diagnosis of Acute Respiratory Distress Syndrome (ARDS)\n* The severity of COVID-19 in this group is determined by a P/F ratio at ICU admission, indicating a higher level of hypoxemia and a more critical clinical condition.\n* The diagnosis of COVID-19 in these patients was confirmed using the Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) technique.\n* RT-PCR involves collecting a sample from the lower respiratory tract and detecting the presence of SARS-CoV-2 viral RNA.", "interventionNames"=>["Other: Respiratory drive and effort assessment"]}], "interventions"=>[{"name"=>"Respiratory drive and effort assessment", "type"=>"OTHER", "description"=>"The use of a neurally-adjusted ventilatory assist catheter, the measurement of electrical activity of the diaphragm, ∆Pocc, P0.1, and other ventilatory parameters to assess respiratory drive and effort in three cohorts of patients", "armGroupLabels"=>["COVID-Moderate", "COVID-Severe", "Non-COVID"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"10126", "city"=>"Turin", "country"=>"Italy", "facility"=>"S.C. Anestesia e Rianimazione 1U A.O.U.- Città della Salute e della Scienza, P.O. Molinette Corso Bramante 88-90", "geoPoint"=>{"lat"=>45.07049, "lon"=>7.68682}}], "overallOfficials"=>[{"name"=>"Vito Fanelli, MD, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Turin, Italy"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Turin, Italy", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Associate Professor", "investigatorFullName"=>"Vito Fanelli MD, PhD", "investigatorAffiliation"=>"University of Turin, Italy"}}}}
