[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sedation-for-mechanical-ventilation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sedation-for-mechanical-ventilation":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,61],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100640195","feasibility-of-protocolised-analgosedation-in-ecmo-100640195",false,"NCT07580781","Feasibility of Protocolised Analgosedation in ECMO","Feasibility of a Cluster Randomised Control Trial Evaluating a Co-designed Analgosedation Protocol in Extracorporeal Membrane Oxygenation (ECMO) Patients","ECMO-SED","Inclusion Criteria:\n\n* Aged 18 years and older\n* Receiving IV continuous infusions of analgosedation medication\n* Receiving ECMO treatment\n\nExclusion Criteria:\n\n* There will be no exclusion criteria as analgosedation management is routine for all adult ECMO patients.","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","Sedation (painkillers and sedative drugs) treats pain, reduces suffering, and helps patients in the intensive care unit (ICU) receiving extracorporeal membrane oxygenation (ECMO) remain comfortable. ECMO is a life support machine that provides oxygen and removes waste gases (carbon dioxide) in very sick patients with severe heart or lung failure. About 300-400 patients per year receive ECMO in the UK. These patients are younger and generally more healthy compared to other critically ill patients. However patients that survive ECMO have long-term health problems. These include anxiety, memory problems, withdrawal from medicines, and mobility issues. These problems issues could all be related to the type and amount of sedation given.\n\nA sedation protocol is a way of guiding healthcare professionals how much sedation is given to patients in ICU. Too much sedation can cause confusion, hallucinations, excessive sleepiness, and longer time in hospital. Too little sedation can cause pain, distress, and also a longer time in hospital. Using a sedation protocol in non-ECMO patients has been shown to reduce these complications.\n\nHowever, there are no protocols for giving sedation to ECMO patients in research papers. Investigators know healthcare staff find it difficult to manage sedation, and higher amounts of sedation is given to ECMO patients.\n\nAims:\n\nTo see whether it is possible to run a trial that compares using a sedation protocol against usual care.\n\nDesign\u002Fmethods:\n\nThirty to 60 ECMO patients will be chosen and will be put into one of two groups. One group will receive usual care, and the other will receive care using the sedation protocol. The investigators will collect information from both groups to find out if the study design works and how many patients agree to take part.\n\nPatient and public involvement\u002Fengagement:\n\nThe investigators received feedback from patients and family member participants which helped to design this proposal, the lay summary and what to measure in a trial. They will advise how the investigators should review study findings, and support sharing of results to the public.\n\nImpact\u002Fdissemination:\n\nThe investigators will share findings through social media, patient charities, research papers and conferences.",[27,28,29,30,31,32,33,34],"Intensive Care (ICU)","Respiratory Distress Syndrome (RDS)","Sedation and Analgesia","Extracorporeal Membrane Oxygenation","Sedation for Mechanical Ventilation","Cardiogenic Shock","Opioid Analgesia","Analgesia",[36,37,38,39,40,41,42,43,44,45,46,47],"extracorporeal membrane oxygenation","sedation","opioid","sedative","analgosedation","mechanical ventilation","ECMO","ICU","Intensive Care Unit","Critical Care","sedation protocol","analgesia","NOT_YET_RECRUITING","2026-05-05",{"date":51,"type":52},"2026-05-12","ACTUAL",{"date":54,"type":21},"2026-09-01",{"date":56,"type":21},"2027-08-31",{"name":58,"class":59},"Guy's and St Thomas' NHS Foundation Trust","OTHER",1,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":15,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":84,"locationsCount":60},"100595479","improving-sedation-practice-in-critically-ill-adult-patients-using-a-co-designed-sedation-protocol-100595479","NCT07032987","Improving Sedation Practice in Critically Ill Adult Patients Using a Co-designed Sedation Protocol","Optimising Analgosedation in Extracorporeal Membrane Oxygenation (ECMO) Using a Co-designed Analgosedation Protocol","Stage 1 (multi-centre observational study):\n\nInclusion Criteria:\n\n1. Aged 18 years and older.\n2. Receiving continuous IV infusions of analgosedation (opioids, benzodiazepines, and\u002For propofol).\n3. Receiving ECMO for moderate to severe respiratory failure (PaO2\u002FFiO2 (P\u002FF) ratio \\\u003C20 kilopascals (kPa)) for ≤ 7 days during the week of recruitment.\n4. Non-ECMO ICU patients (control group): must satisfy inclusion criteria 1 and 2, and have received mechanical ventilation for moderate to severe respiratory failure (P\u002FF ratio \\\u003C 20kPa) for at least 48 hours OR mechanical ventilation for cardiovascular disorder (out of hospital cardiac arrest, following cardiothoracic or transplant surgery or percutaneous coronary intervention or acute heart failure).\n\nExclusion Criteria:\n\n1. Anticipated length of ICU stay in recruiting centre for less than 24 hours.\n2. Withdrawal of life-sustaining treatment in the next 24 hours.\n\nStage 2 (mixed methods study):\n\nInclusion Criteria:\n\n1. Healthcare professionals working at one of two ECMO centres (St Thomas' Hospital and Royal Brompton Hospital (part of Guy's and St Thomas' NHS Foundation Trust).\n2. ECMO survivors (patients admitted to ICU and survived ECMO organ support) who have returned home, and recovered.\n3. Family members of ECMO survivors, whose relative is no longer hospitalised.\n\nExclusion Criteria:\n\n1. ECMO survivors currently receiving treatment in hospital.\n2. ECMO survivors with severe cognitive issues (issues with short-term memory and thinking).\n3. ECMO survivors who cannot communicate in English.\n4. Non-ECMO survivors and family members.","100 Years",{"count":70,"type":21},120,"OBSERVATIONAL","Sedation (painkillers and sedative drugs) treats pain, reduces suffering, and helps patients in the intensive care unit (ICU) receiving extracorporeal membrane oxygenation (ECMO) remain comfortable. ECMO is a life support machine that provides oxygen and removes waste gases (carbon dioxide) in very sick patients with severe heart or lung failure. About 300-400 patients per year receive ECMO in the UK. These patients are younger and generally more healthy compared to other critically ill patients. However patients that survive ECMO have long-term health problems. These include anxiety, memory problems, withdrawal from medicines, and mobility issues. These problems issues could all be related to the type and amount of sedation given.\n\nA sedation protocol is a way of guiding healthcare professionals how much sedation is given to patients in ICU. Too much sedation can cause confusion, hallucinations, excessive sleepiness, and longer time in hospital. Too little sedation can cause pain, distress, and also a longer time in hospital. Using a sedation protocol in non-ECMO patients has been shown to reduce these complications.\n\nHowever, there are no protocols for giving sedation to ECMO patients in research papers. The investigators know healthcare staff find it difficult to manage sedation, and higher amounts of sedation is given to ECMO patients.\n\nAims:\n\n* To describe current sedation use in ECMO patients in the UK and compare to non-ECMO critically ill patients.\n* To develop a sedation protocol for ECMO patients with input from patients, their family, and staff.\n\nDesign\u002Fmethods:\n\nStudy 1:\n\nThe investigators will study how sedation is used in adult ECMO patients and compare with non-ECMO but critically ill patients in the UK. The investigators will collect information on drug doses and pain and sedation scores. The investigators will also ask ECMO centres if they use a sedation protocol to adjust sedation doses. This information will be helpful for the design of the protocol in study 2.\n\nStudy 2:\n\nThe investigators will design a sedation protocol with input from patients, family, and staff. The investigators will organise meetings to share experiences and agree on what to include in the protocol that is considered acceptable and safe. The investigators will then assess if the protocol is safe and acceptable with staff outside the co-design group.\n\nPatient and public involvement\u002Fengagement:\n\nThe investigators received feedback from patients and family members which helped to design this proposal, the lay summary and what to measure in a trial. Patients and family members will continue to help with development of the sedation and trial protocol. They will advise how the investigators should review study findings, and support sharing of results to the public.\n\nImpact\u002Fdissemination:\n\nThe investigators will share findings through social media, patient charities, research papers and conferences.",[74,28,29,75,31,32,33,34],"Intensive Care Medicine","ExtraCorporeal Membrane Oxygenation (ECMO)",[36,37,38,77,40,41,42,43,44,45,46,47],"sedatives","RECRUITING",{"date":80,"type":52},"2026-05-08",{"date":82,"type":52},"2025-11-24",{"date":56,"type":21},{"name":58,"class":59}]