[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517176":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":60,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":25,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":25,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Guy's and St Thomas' NHS Foundation Trust","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional intravenous sedation","ACTIVE_COMPARATOR","Conventional intravenous sedation (e.g. propofol) with short acting opioid, titrated to a clinically prescribed sedation score. Period of observation will be 2 hours pre-cross over and 2 hours post cross over.",[13],"Drug: Propofol",{"label":15,"type":10,"description":16,"interventionNames":17},"Inhaled volatile sedation","Inhaled volatile sedation (Isoflurane) delivered via the AnaConDa device for a 6 hour period (2 hours washout of intravenous sedation \u002F wash-in of volatile to achieve stable baseline, followed by 4 hours of observations at steady state) titrated to an equivalent sedation score. During this period opioid infusion should be maintained at baseline level unless clinical indication for titration of dose.",[18],"Drug: Isoflurane",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Propofol","Standard care, propofol sedation - 2 hour periods of observation before and after inhaled volatile sedation",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Isoflurane","Inhaled volatile sedation for 6 hours - 2 hours wash in \u002F wash out, followed by 4 hours of observations",[15],[31],{"name":32,"affiliation":5,"role":33},"Guy Glover","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","00447879696250","guy.glover@gstt.nhs.uk",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Gill Radcliffe","02071887188","gillian.radcliffe@gstt.nhs.uk",[44],{"facility":45,"status":46,"city":47,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Guy's & St Thomas' NHS Foundation Trust","RECRUITING","London","SE1 9RT","United Kingdom","UK",{"type":52,"coordinates":53},"Point",[54,55],-0.12574,51.50853,{"lat":55,"lon":54},[58],{"name":40,"role":36,"phone":59,"phoneExt":25,"email":42},"02071888070",{"type":61,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[63],{"name":64,"class":65},"Sedana Medical","INDUSTRY","100517176","phase-2-volatile-sedation-for-patients-with-the-acute-respiratory-distress-syndrome-100517176",false,"NCT06014138","Volatile Sedation for Patients With the Acute Respiratory Distress Syndrome","Effect of Volatile Sedation on Spontaneous Breathing During Mechanical Ventilation for Patients With the Acute Respiratory Distress Syndrome","ISO-DRIVE","Inclusion Criteria:\n\n* Adult patients admitted to the Intensive Care Unit (ICU)\n* ARDS\n* Invasive mechanical ventilation (IMV)\n* Spontaneous breathing in pressures support mode (PSV) for less than or equal to 48 hours\n* Sedated with intravenous sedation (ie. propofol and \u002F or midazolam and fentanyl or alternate short acting opioid)\n* Anticipated to remain on IMV and PSV and with a stable sedation score for a further 24 hours without planned sedation interruption \u002F spontaneous breathing trial or other significant change in the level of ventilator support\n* Not receiving \u002F anticipated to receive paralysis\n* In supine position\n\nExclusion Criteria:\n\n* Personal or family history of malignant hyperpyrexia\n* Known or suspected elevated intracranial pressure\n* High dose vasopressors (ie. Noradrenaline \\> 0.3mcg\u002Fkg\u002Fmin or equivalent)\n* Contra-indication to oesophageal balloon (i.e. oesophageal \u002F upper gastro-intestinal pathology)\n* Pregnancy\n* High dose oral sedatives (e.g. benzodiazepines) or opioids (e.g. oxycodone \u002F oral morphine) which may affect respiratory drive","ALL","17 Years",{"count":77,"type":78},20,"ESTIMATED","INTERVENTIONAL",[81,82],"PHASE2","PHASE3","This study will investigate how different types of routine sedation may affect patient's breathing whilst on a ventilator in the Intensive Care Unit (ICU). There are different approaches to sedation which may have advantages and disadvantages. During the study patients will receive both intravenous and inhaled volatile sedation (similar to anaesthetic 'gases' used for general anaesthesia) and the drive to breath, breathing efforts and function of the lung will be assessed.",[85,86,87],"Acute Respiratory Distress Syndrome","Mechanical Ventilation Complication","Sedation Complication","2026-06-03",{"date":90,"type":91},"2026-06-04","ACTUAL",{"date":93,"type":91},"2023-11-01",{"date":95,"type":78},"2027-07-31",{"name":5,"class":6},1]