[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553817":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":45,"responsibleParty":63,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Hospital Clinic of Barcelona","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MI-E intervention protocol","EXPERIMENTAL","The optimized MI-E setting will consist of in-expiratory pressures defined during the previous short-period test to achieve inspiratory volumes of ≥1 liter and PEF ≥80 L\u002Fmin",[13],"Device: MI-E Intervention protocol",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard MI-E setting","ACTIVE_COMPARATOR","The standard MI-E setting will consist of in-expiratory pressures of +40\u002F-40 cmH2O, medium inspiratory flow, with 3 seconds and 2 seconds of in-expiratory time, respectively, and 1-second pause",[19],"Device: Standard MI-E setting",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","MI-E Intervention protocol","The endotracheal tube cuff will be inflated to 40 cmH2O and MI-E device will be used to deliver MI-E in automatic mode, with 4 sets of 5 respiratory cycles each and a 1-minute interval between each set.\n\nBefore initiation of the MI-E intervention protocol, the investigators will carry out a short-period test to find the appropriate MI-E settings to achieve inspiratory volumes of ≥1 liter and PEF ≥80 L\u002Fmin. Concretely, inspiratory and expiratory time will always be set at 4 seconds and 2 seconds, respectively, and inspiratory flow will always be in slow mode. Once the appropriate inspiratory pressure will be found, the expiratory pressure will be initially set to exceed in 30 cmH2O the inspiratory pressure and, if required, this will be increased by 5 cmH2O until achieving a PEF ≥80 L\u002Fmin with a maximum expiratory pressure of 70 cmH2O.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Cough Assist E70 device (Philips Respironics, USA, Andover, Massachusetts) will be used to deliver MI-E in automatic mode, with 4 sets of 5 respiratory cycles each and a 1-minute interval between each set. During the 1-minute pause between sets, the patient will be reconnected to the ventilator to avoid desaturation and de-recruitment during procedures. PEEP will remain stable during the protocol.\n\nThe standard MI-E setting will consist of in-expiratory pressures of +40\u002F-40 cmH2O, medium inspiratory flow, with 3 seconds and 2 seconds of in-expiratory time, respectively, and 1-second pause.",[15],[31],{"name":32,"affiliation":5,"role":33},"Joan Daniel Martí, PhD","PRINCIPAL_INVESTIGATOR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Dani M Romeu, PhD","CONTACT","93-2275400","5710","jd.martibcn@gmail.com",{"name":42,"role":37,"phone":43,"phoneExt":26,"email":44},"Gonzalo Basllesteros Reviriego, Msc","0034659129059","ballestero15@gmail.com",[46],{"facility":47,"status":48,"city":49,"state":26,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Hospital Clinic de Barcelona","RECRUITING","Barcelona","08036","Spain","ES",{"type":54,"coordinates":55},"Point",[56,57],2.15899,41.38879,{"lat":57,"lon":56},[60],{"name":61,"role":37,"phone":62,"phoneExt":26,"email":40},"Joan-Daniel Martí, PhD","0034627954827",{"type":33,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Joan-Daniel Martí Romeu","Principal Investigator","100553817","effects-of-mechanical-insufflation-exsufflation-with-optimized-settings-on-wet-mucus-volume-during-invasive-ventilation-100553817",false,"NCT06491017","Effects of Mechanical Insufflation-Exsufflation With Optimized Settings on Wet Mucus Volume During Invasive Ventilation","Effects of Mechanical Insufflation-Exsufflation With Optimized Settings on Suctioned Wet Mucus Volume During Invasive Ventilation","Inclusion Criteria:\n\n* Adults (\\> 18yo).\n* Endotracheal intubation and invasive mechanical ventilation for \\> 48h and active humidification for \\> 24h.\n* Richmond Agitation-Sedation Scale -3 to -5.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patients with hemodynamic instability (MAP \\\u003C 60 or \\> 110, Heart Rate \\\u003C 50 or \\> 130, new onset arrhythmias), respiratory instability (PEEP \\> 12cmH2O, SpO2 \\\u003C 90% or fraction of inspired oxygen (FiO2) \\> 60%).\n* Undrained pneumothorax\u002Fpneumomediastinum.\n* Unstable intracranial pressure (ICP \\> 20mmHg or MAP \\\u003C 60).\n* Severe bronchospasm.\n* Post cardiothoracic surgical patients.\n* Active pulmonary tuberculosis.\n* Bronchoesophageal or bronchopleural fistulas.\n* Prone position.\n* Pregnancy.",true,"ALL","18 Years",{"count":77,"type":78},26,"ESTIMATED","INTERVENTIONAL",[81],"NA","Retention of airway secretions is a frequent complication in critically ill patients requiring invasive mechanical ventilation (MV).This complication is often due to excessive secretion production and ineffective secretion clearance.\n\nMechanical insufflator-exsufflator (MI-E) is a respiratory physiotherapy technique that aims to assist or simulate a normal cough by using an electro-mechanical dedicated device. A positive airway pressure is delivered to the airways, in order to hyperinflate the lungs, followed by a rapid change to negative pressure that promotes a rapid exhalation and enhances peak expiratory flows.\n\nHowever, there is no consensus on the best MI-E settings to facilitate secretion clearance in these patients. Inspiratory and expiratory pressures of ±40 cmH2O and inspiratory-expiratory time of 3 and 2 seconds, respectively, are often used as a standard for MI-E programming in the daily routine practice, but recent laboratory studies have shown significant benefits when MI-E setting is optimized to promote an expiratory flow bias.\n\nThe investigators designed this study to compare the effects of MI-E with an optimized setting versus a standard setting on the wet volume of suctioned sputum in intubated critically ill patients on invasive MV for more than 48 hours.",[84,85],"Mucus Retention","Mechanical Ventilation Complication",[87,88,89,90],"Mechanical insufflation-exsufflation","Physiotherapy","Mucus retention","mechanical ventilation","2026-05-07",{"date":93,"type":94},"2026-05-08","ACTUAL",{"date":93,"type":94},{"date":97,"type":78},"2028-12",{"name":5,"class":6},1]