[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100238445":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":24,"locations":40,"responsibleParty":62,"collaborators":24,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":24,"enrollmentInfo":73,"targetDuration":24,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":84,"whyStopped":24,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"York Teaching Hospitals NHS Foundation Trust","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual care","EXPERIMENTAL","No intervention apart from application of clearsight monitor. Prior to induction of anaesthesia the control group will have a Clearsight cardiac monitor probe placed on a suitable finger and baseline haemodynamic measurements will be taken. All fluid management and administration of vasopressor therapy will be at the discretion of the anaesthetist as per the current practice at the host institution. Data on stroke volume, heart rate, blood pressure, cardiac output, oxygen saturations, will be recorded at baseline and then every 5 minutes.",[13],"Device: Application of clearsight monitor",{"label":15,"type":10,"description":16,"interventionNames":17},"Fluid optimisation","Application of clearsight monitor, optimisation of blood pressure and fluid optimisation. A Clearsight cardiac probe is attached and after induction of anaesthesia stroke volume is optimised using 250ml boluses of Hartmann's solution. The SV measurement prior to the final fluid bolus will be the optimal SV. Mean arterial blood pressure will be maintained within 30% of baseline values using a phenylephrine infusion.Data on haemodynamics will be recorded at baseline and then every 5 minutes, as well as before and after a fluid bolus. Haemoglobin will be maintained at\\>10g\u002FdL with blood transfusion as required.",[18,19,13],"Other: Fluid optimisation","Drug: Optimisation of blood pressure",[21,25,30],{"type":6,"name":15,"description":22,"armGroupLabels":23,"otherNames":24},"The intervention will consist of optimising stroke volume with 250ml of Hartmanns solution",[15],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"DRUG","Optimisation of blood pressure","Phenylephrine infusion will be used to target a mean arterial blood pressure to within 30% of baseline (preoperative) value",[15],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":24},"DEVICE","Application of clearsight monitor","The clear sight monitor will be applied to measure stroke volume.",[15,9],[36],{"name":37,"affiliation":38,"role":39},"Simon Davies, MB FRCA MD","York Teaching Hospital","PRINCIPAL_INVESTIGATOR",[41,53],{"facility":5,"status":24,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":24},"York","North Yorkshire","YO318HE","United Kingdom","UK",{"type":48,"coordinates":49},"Point",[50,51],-1.08271,53.95763,{"lat":51,"lon":50},{"facility":54,"status":24,"city":55,"state":56,"zip":24,"country":45,"countryCode":46,"cosmosGeoPoint":57,"geoPoint":61,"contacts":24},"Harrogate Hospital","Harrogate","Yorkshire",{"type":48,"coordinates":58},[59,60],-1.5373,53.99078,{"lat":60,"lon":59},{"type":63,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100238445","non-invasive-cardiac-output-monitoring-to-guide-goal-directed-fluid-therapy-in-high-risk-patients-undergoing-urgent-surgical-repair-of-proximal-femoral-fractures-100238445",false,"NCT02382185","Non Invasive Cardiac Output Monitoring to Guide Goal Directed Fluid Therapy in High Risk Patients Undergoing Urgent Surgical Repair of Proximal Femoral Fractures","ClearNOF","Inclusion Criteria:\n\n* Patients due to undergo urgent or emergency repair of a proximal femoral fracture who have a Nottingham hip fracture score (NHFS) ≥ 5 i.e. patients who are regarded as 'high risk'.\n\nExclusion Criteria:\n\n* Age \\\u003C 50 years. Patients scoring 5 on the American Society of Anesthesiologists (ASA) physical status classification Multiple injuries requiring operative management","ALL","50 Years",{"count":74,"type":75},240,"ACTUAL","INTERVENTIONAL",[78],"NA","Improving or maximising cardiac output in the perioperative setting through the use of goal directed fluid therapy has been shown to reduce complications and length of hospital stay in patients undergoing major abdominal surgery. The evidence for patients having surgery to repair a fractured neck of femur is less robust but many of these latter patients are elderly and often at high risk of complications.\n\nPatients undergoing surgery (including surgery for hip fracture) under spinal anaesthesia have not had access to goal directed fluid therapy because of the invasive nature of the existing monitoring technology such as oesophageal doppler. The availability of a non invasive cardiac monitoring device, the Clearsight™, now makes goal directed fluid therapy a possibility for this group of patients.\n\nThis is a randomised controlled, observer blinded trial to assess the effects of goal directed fluid therapy in high-risk patients undergoing surgical repair of proximal femoral fractures.\n\nThe aim of the trial is to test the hypothesis that maximising circulating volume intra-operatively with balanced crystalloid reduces post-operative morbidity in high-risk patients undergoing urgent surgical repair of proximal femoral fractures.",[81],"Hip Fractures",[83],"Cardiac output","COMPLETED","2018-06-28",{"date":87,"type":75},"2018-07-02",{"date":89,"type":75},"2015-01",{"date":91,"type":75},"2017-09-28",{"name":5,"class":6},2]