[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560539":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":32,"locations":41,"responsibleParty":161,"collaborators":12,"id":165,"slug":166,"hasResults":167,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":167,"sex":173,"minAge":174,"maxAge":12,"enrollmentInfo":175,"targetDuration":12,"studyType":178,"phases":179,"briefSummary":181,"conditions":182,"keywords":186,"overallStatus":75,"whyStopped":12,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},{"fullName":5,"class":6},"Sydney Local Health District","OTHER_GOV",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control period","NO_INTERVENTION","The control period includes a period whereby clinicians will not have access to ETO2 monitoring and routine RSI practices will be documented including all study variables. At all institutions, RSI is performed in a similar manner, utilising an airway checklist. There is no 'standard operating procedure' for RSI in any of the EDs and methods, therefore, vary depending on clinician preference and the condition of the patient, however, each site is a tertiary-level, university teaching hospital and therefore clinical practice is up to date and evidence-based. Standard preoxygenation methods in the Emergency department often consist of a bag-valve mask, with or without a PEEP valve, set at 15L\u002Fmin, or the use of non-invasive ventilation or a non-rebreather mask, with or without a nasal cannula, set at 15 L\u002Fmin or flush rate oxygen (\\>40 L\u002Fmin). US sites have access to high-flow (\\>30L\u002Fmin) oxygen. This is the only difference in the preoxygenation method.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Study period","EXPERIMENTAL","For all patients involved in the study, the only intervention will be the use of ETO2 to guide preoxygenation. All aspects of RSI will be at the discretion of the treating clinician including sedative\u002Fparalytic medications, positioning of the patient, preoxygenation method, intubation techniques and post-intubation sedation.\n\nClinicians will be encouraged to aim for the highest ETO2 result possible with a goal of \\>85%. Clinicians will be able to view the ETO2 values and can decide on any changes to the preoxygenation techniques if deemed necessary. These techniques may include improved patient positioning, improved face mask seal, increased oxygen flow, length of preoxygenation time, or altering the preoxygenation device.",[18],"Device: End-tidal oxygen monitor",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","End-tidal oxygen monitor","The only additional equipment required for this study is the Philips™ IntelliVue G7m Gas Analyser Module 866173. This provides a non-dispersive infrared measurement of respiratory gases and a paramagnetic measurement of oxygen. At Lincoln Medical Center, the gas analyser used will be a Philips G5 gas analyser connected to a Philips Intellivue MP 70. At the University of New Mexico Medical Center, the Masimo root monitor is used.\n\nThe gas analysers produce display waves for O2 and CO2, together with numerics for end-tidal values for O2 and CO2 and to our knowledge, there are no differences in values between the various devices used. The gas sampling occurs through a side-stream sampling tube at a rate of 200ml\u002Fmin ±20 ml\u002Fmin, which is either obtained from a nasal cannula in the spontaneously breathing patient or a sidestream line if connected to a BVM.",[14],[26,29],{"name":27,"affiliation":5,"role":28},"Matthew Oliver, MBBS","STUDY_CHAIR",{"name":30,"affiliation":31,"role":28},"Nick Caputo, Md","Lincoln Medical Center",[33,37],{"name":27,"role":34,"phone":35,"phoneExt":12,"email":36},"CONTACT","+61410188680","matthew.oliver@health.nsw.gov.au",{"name":38,"role":34,"phone":39,"phoneExt":12,"email":40},"Naomi Derrick","+61457240478","naomi.derrick@health.nsw.gov.au",[42,60,74,88,104,113,122,134,148],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Hennepin Medical Center","NOT_YET_RECRUITING","Minneapolis","Minnesota","55451","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-93.26384,44.97997,{"lat":54,"lon":53},[57],{"name":58,"role":34,"phone":12,"phoneExt":12,"email":59},"Brian Driver, MD","briandriver@gmail.com",{"facility":61,"status":44,"city":62,"state":63,"zip":64,"country":48,"countryCode":49,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"University of New Mexico Medical Center","Albuquerque","New Mexico","87106",{"type":51,"coordinates":66},[67,68],-106.65114,35.08449,{"lat":68,"lon":67},[71],{"name":72,"role":34,"phone":12,"phoneExt":12,"email":73},"Darren Braude, MD","DBraude@salud.unm.edu",{"facility":31,"status":75,"city":76,"state":77,"zip":78,"country":48,"countryCode":49,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"RECRUITING","The Bronx","New York","10451",{"type":51,"coordinates":80},[81,82],-73.86641,40.84985,{"lat":82,"lon":81},[85],{"name":86,"role":34,"phone":12,"phoneExt":12,"email":87},"Nicholas Caputo, MD","ncaputo.md@gmail.com",{"facility":89,"status":44,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Westmead Hospital","Sydney","New South Wales","2000","Australia","AU",{"type":51,"coordinates":96},[97,98],151.20732,-33.86785,{"lat":98,"lon":97},[101],{"name":102,"role":34,"phone":12,"phoneExt":12,"email":103},"Andrew Coggins, MBBS","andrewrcoggins@gmail.com",{"facility":105,"status":75,"city":90,"state":91,"zip":106,"country":93,"countryCode":94,"cosmosGeoPoint":107,"geoPoint":109,"contacts":110},"Royal Prince Alfred Hospital","2050",{"type":51,"coordinates":108},[97,98],{"lat":98,"lon":97},[111,112],{"name":27,"role":34,"phone":35,"phoneExt":12,"email":36},{"name":38,"role":34,"phone":39,"phoneExt":12,"email":40},{"facility":114,"status":44,"city":90,"state":91,"zip":12,"country":93,"countryCode":94,"cosmosGeoPoint":115,"geoPoint":117,"contacts":118},"Liverpool Hospital",{"type":51,"coordinates":116},[97,98],{"lat":98,"lon":97},[119],{"name":120,"role":34,"phone":12,"phoneExt":12,"email":121},"Ian Ferguson, MBBS","Ian.Ferguson@health.nsw.gov.au",{"facility":123,"status":75,"city":90,"state":91,"zip":12,"country":93,"countryCode":94,"cosmosGeoPoint":124,"geoPoint":126,"contacts":127},"Northern Beaches Hospital",{"type":51,"coordinates":125},[97,98],{"lat":98,"lon":97},[128,131],{"name":129,"role":34,"phone":12,"phoneExt":12,"email":130},"Cliff Reid, MBBS","Cliff.Reid@health.nsw.gov.au",{"name":132,"role":34,"phone":12,"phoneExt":12,"email":133},"Brian Burns, MBBS","Brian.Burns@health.nsw.gov.au",{"facility":135,"status":44,"city":90,"state":91,"zip":12,"country":93,"countryCode":94,"cosmosGeoPoint":136,"geoPoint":138,"contacts":139},"Royal North Shore Hospital",{"type":51,"coordinates":137},[97,98],{"lat":98,"lon":97},[140,143,146],{"name":141,"role":34,"phone":12,"phoneExt":12,"email":142},"Toby Fogg, MBBS","tobyfogg@mac.com",{"name":144,"role":34,"phone":12,"phoneExt":12,"email":145},"Chris Partyka, MBBS","chrispartyka@gmail.com",{"name":147,"role":34,"phone":12,"phoneExt":12,"email":12},"John Vassiliadis",{"facility":149,"status":44,"city":150,"state":151,"zip":12,"country":93,"countryCode":94,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"The Alfred Hospital","Melbourne","Victoria",{"type":51,"coordinates":153},[154,155],144.96332,-37.814,{"lat":155,"lon":154},[158],{"name":159,"role":34,"phone":12,"phoneExt":12,"email":160},"Chris Groombridge, MBBS","c.groombridge@alfred.org.au",{"type":162,"investigatorFullName":163,"investigatorTitle":164,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Matthew Oliver","Staff Specialist","100560539","end-tidal-oxygen-for-intubation-in-the-emergency-department-100560539",false,"NCT06578468","End-Tidal Oxygen for Intubation in the Emergency Department","Preoxygenation Using End-Tidal Oxygen for Rapid Sequence Intubation in the Emergency Department (The PREOXED Trial) - a Multicentre Stepped Wedge Cluster Randomised Control Trial","PREOXED","Inclusion Criteria:\n\n1. The patient is located in the ED resuscitation bay of the participating centre.\n2. The planned procedure is orotracheal intubation using a laryngoscope and RSI technique with preoxygenation for patients who are spontaneously breathing.\n3. The patient is deemed to be at a high risk of hypoxia during RSI as per the treating ED clinician, as defined by:\n\n   * Any patient requiring any form of oxygen therapy before preoxygenation.\n   * Any patient with respiratory pathology based on clinical or radiological findings. Including, but not limited to:\n\n     * Pneumonia, pulmonary oedema, acute respiratory distress syndrome (ARDS), aspiration, pulmonary contusion from trauma, infective exacerbations of known lung disease (e.g. asthma, pulmonary fibrosis, emphysema) or pulmonary embolism (PE)\n   * Any patient with high oxygen consumption. Including, but not limited to:\n\n     * Sepsis, Diabetic ketoacidosis, alcohol or drug withdrawal, seizures, thyrotoxicosis\n   * Any underlying patient condition that may predispose to hypoxemia. Including, but not limited to:\n\n     * Obesity, pregnancy, underlying lung disease (e.g. asthma, pulmonary fibrosis, emphysema), severe injury- hypovolaemia\u002Fhaemorrhage.\n   * or any other patient that the treating clinician has a high concern for hypoxemia during RSI.\n\nExclusion Criteria:\n\n1. Patient is known to be less than 18 years old.\n2. The patient has a supraglottic device in-situ e.g iGel or LMA.\n3. The patient is known to be pregnant.\n4. The patient is known to be a prisoner.\n5. The patient was intubated in the prehospital environment.\n6. Immediate need for tracheal intubation precludes preoxygenation i.e. the patient is in cardiac arrest.","ALL","18 Years",{"count":176,"type":177},1400,"ESTIMATED","INTERVENTIONAL",[180],"NA","Rapid Sequence Intubation (RSI) is a high-risk procedure in the emergency department (ED). Patients are routinely preoxygenated (given supplemental oxygen) prior to RSI to prevent hypoxia during intubation. For many years anaesthetists have used end-tidal oxygen (ETO2) levels to guide the effectiveness of preoxygenation prior to intubation. The ETO2 gives an objective measurement of preoxygenation efficacy. This is currently not available in most EDs.\n\nThis trial evaluates the use of ETO2 on the rate of hypoxia during intubation for patients in the ED.",[183,184,185],"Critical Illness","Hypoxia","Respiratory Failure",[187],"Emergency Intubation","2024-09-04",{"date":190,"type":191},"2024-09-19","ACTUAL",{"date":193,"type":191},"2024-08-05",{"date":195,"type":177},"2025-12-31",{"name":5,"class":6},9]