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program",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Standard care",null,[20],{"type":6,"name":11,"description":21,"armGroupLabels":22,"otherNames":18},"Non-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed",[9],[24,27],{"name":25,"affiliation":5,"role":26},"Bram Tilburgs, PhD","PRINCIPAL_INVESTIGATOR",{"name":28,"affiliation":5,"role":29},"Mark van den Boogaard, PhD","STUDY_DIRECTOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Rens Kooken, MSc","CONTACT","+31 24 361 6735","rens.kooken@radboudumc.nl",{"name":25,"role":33,"phone":37,"phoneExt":18,"email":38},"+31 24 361 4996","bram.tilburgs@radboudumc.nl",[40,55,66,77,88],{"facility":41,"status":42,"city":43,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Noordwest Ziekenhuisgroep","RECRUITING","Alkmaar","Netherlands","NL",{"type":47,"coordinates":48},"Point",[49,50],4.74861,52.63167,{"lat":50,"lon":49},[53],{"name":54,"role":33,"phone":18,"phoneExt":18,"email":18},"Wouter de Ruijter, MD, PhD",{"facility":56,"status":42,"city":57,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Bravis Ziekenhuis","Bergen op Zoom",{"type":47,"coordinates":59},[60,61],4.29167,51.495,{"lat":61,"lon":60},[64],{"name":65,"role":33,"phone":18,"phoneExt":18,"email":18},"Bram Simons, MD",{"facility":67,"status":42,"city":68,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Amphia Ziekenhuis","Breda",{"type":47,"coordinates":70},[71,72],4.77596,51.58656,{"lat":72,"lon":71},[75],{"name":76,"role":33,"phone":18,"phoneExt":18,"email":18},"Thijs Rettig, MD, PhD",{"facility":78,"status":42,"city":79,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Elkerliek Ziekenhuis","Helmond",{"type":47,"coordinates":81},[82,83],5.66111,51.48167,{"lat":83,"lon":82},[86],{"name":87,"role":33,"phone":18,"phoneExt":18,"email":18},"Rens van de Weyer, MD",{"facility":89,"status":42,"city":90,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"VieCuri Medisch Centrum","Venlo",{"type":47,"coordinates":92},[93,94],6.16806,51.37,{"lat":94,"lon":93},[97],{"name":98,"role":33,"phone":18,"phoneExt":18,"email":18},"Quirine Habes, MD, PhD",{"type":100,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[102],{"name":103,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development","100499457","a-multicomponent-intervention-program-to-prevent-and-reduce-icu-agitation-and-physical-restraint-use-100499457",false,"NCT05783505","A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use","PRevention of pAtient's agItation and Enhancement of Their SafEty (PRAISE): Improving Intensive Care Treatment Using a Multicomponent Pharmacological Intervention","PRAISE","Inclusion criteria:\n\n* Adult ICU patients (aged ≥18) with an expected ICU stay of \\>24 hours\n* Patients who are (expected to become) agitated within the first 14 days of their ICU admission\n\nExclusion criteria:\n\n* Contra indication for dexmedetomidine use (i.e., AV-block grade 2 or 3 unless a pacemaker is present, uncontrolled hypotension, acute cerebrovascular condition or known\u002Fsuspected hypersensitivity);\n* Neurological patients with an (expected risk of) increased intracranial pressure;\n* An intoxication as a result of drug abuse (e.g., ethanol, γ-Hydroxybutyrate, opioids, benzodiazepines);\n* Support with Extracorporeal Membrane Oxygenation (ECMO);\n* Difficult airway (e.g., a Cormack and Lehane laryngoscopy grade 4 view or a tumor causing airway obstruction);\n* A high risk of physical aggression towards healthcare professionals;\n* No consent for long term follow up in the MONITOR-IC study;\n* Not able to read or understand the Dutch language and no relatives able to assist;\n* Enrolment in other sedation studies.","ALL","18 Years",{"count":115,"type":116},480,"ESTIMATED","INTERVENTIONAL",[119],"NA","Despite deleterious effects, physical restraints are still commonly used in (expected to become) agitated patients in Dutch ICUs (20-25%). This study aims to determine the effectiveness of a person-centered multicomponent intervention (MCI) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints in (expected to become) agitated adult ICU patients.",[122],"Agitation,Psychomotor",[124,125,126,127,128],"ICU","Agitation","Physical Restraints","Non-pharmacologic interventions","Dexmedetomidine","2025-06-12",{"date":131,"type":132},"2025-06-17","ACTUAL",{"date":134,"type":132},"2023-06-01",{"date":136,"type":116},"2026-10-01",{"name":5,"class":6},5]