[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100372999":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":26,"centralContacts":44,"locations":54,"responsibleParty":72,"collaborators":26,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":26,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":26,"enrollmentInfo":84,"targetDuration":26,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":26,"overallStatus":57,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Laval University","OTHER",[8,15],{"label":9,"type":6,"description":10,"interventionNames":11},"COPD patients","Patients with acute exacerbation of COPD and respiratory acidosis under oxygen therapy.",[12,13,14],"Other: Washout period","Device: NIV - FreeO2","Device: Nasal High flow Oxygen therapy - FreeO2",{"label":16,"type":6,"description":17,"interventionNames":18},"Bariatric surgery patients","Obese patients after gastric surgery under CPAP.",[19,20],"Other: CPAP - Oxygen constant flow","Other: CPAP - FreeO2",[22,27,32,36,40],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"Washout period","During this period the patients will breath spontaneously oxygen titrated using the FreeO2 device with a SpO2 target set at 90%. The period duration is 30 minutes.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DEVICE","NIV - FreeO2","During this period the patients will receive NIV using FreeO2 device for oxygen titration with a SpO2 target set at 90%. Initially, the inspiratory pressure will be set to obtain a tidal volume between 6 to 8 mL\u002FKg of predictive body weight and positive end-expiratory end pressure (PEEP) at 5 centimeters of water (cmH2O).\n\nAfter NIV initiation, the parameters can be adjusted to improve patient comfort. The period duration is 30 minutes.",[9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"Nasal High flow Oxygen therapy - FreeO2","During this period the patients will receive NHFOT using the FreeO2 device for oxygen titration with a SpO2 target set at 90%. The high flow device will be set at 30 lpm.The period duration is 30 minutes.",[9],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":26},"CPAP - Oxygen constant flow","During this period, the patients will have their own CPAP with oxygen adjusted by hospital staff according to hospital protocol. The period duration is 15 minutes.",[16],{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":26},"CPAP - FreeO2","During this period, the patients will have their own CPAP with oxygen adjusted using the FreeO2 device. SpO2 target will be set at 90% The period duration is 60 minutes.",[16],[45,51],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"François Lellouche, MD, PhD","CONTACT","418-656-8711","3572","Francois.Lellouche@criucpq.ulaval.ca",{"name":52,"role":47,"phone":26,"phoneExt":26,"email":53},"Miguel Trottier, MD, CM","miguel.trottier.1@ulaval.ca",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Institut universitaire de Cardiologie et de Pneumologie - Université Laval","RECRUITING","Québec","Quebec","G1V 4G5","Canada","CA",{"type":64,"coordinates":65},"Point",[66,67],-71.21454,46.81228,{"lat":67,"lon":66},[70],{"name":71,"role":47,"phone":48,"phoneExt":49,"email":26},"François Lellouche",{"type":73,"investigatorFullName":71,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Principal Investigator","100372999","influence-of-freeo2-on-percentage-of-time-within-oxygen-saturation-target-using-noninvasive-ventilation-niv-and-continuous-positive-airway-pressure-cpap-for-patients-admitted-for-aecopd-or-bariatric-surgery-100372999",false,"NCT04136717","Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery","Influence of Automatic Oxygen Titration Device (FreeO2) on Percentage of Time Within Oxygen Saturation Target and Induced Hypercapnia During Noninvasive Ventilation for Patients Hospitalized for an Acute Exacerbation of COPD or a Bariatric Surgery","Inclusion Criteria (AECOPD):\n\n* Respiratory acidosis (pH \\\u003C= 7.35 and PaCO2 \\> 45 mmHg), with or without NIV (last blood gas available during hospitalization)\n* Oxygen therapy and\u002For SpO2 \\\u003C90% room air (FiO2 \\\u003C= 50% or nasal cannula \\\u003C= 7 L\u002Fmin to maintain SpO2 90%)\n* High flow nasal cannula with flow \\\u003C= 30 L\u002Fmin\n\nInclusion Criteria (Bariatric surgery post-op):\n\n* Patients using CPAP before the surgery (obstructive sleep apnea documented).\n* Patients with obesity hypoventilation syndrome in addition to obstructive sleep apnea can be included.\n\nExclusion Criteria:\n\n* Age \\\u003C 18\n* Pregnancy\n* Respiratory distress or other clinical situation requiring continuous NIV or CPAP\n* Glasgow \\\u003C 12 or agitation\u002Fdelirium\u002Fdementia (limiting NIV)\n* Any contraindication to NIV (state requiring immediate endotracheal intubation, pneumothorax, recent esophagus surgery)\n* Hemodynamic instability (at the beginning of the study) (increasing doses of vasopressors or inotropes)\n* Refusal to consent to the study\n\n  5 patient with AECOPD and 5 patient with bariatric surgery will be included.","ALL","18 Years",{"count":85,"type":86},10,"ESTIMATED","INTERVENTIONAL",[89],"NA","The main objective is to evaluate the FreeO2 device combined with noninvasive respiratory support technique for COPD patients and postoperative bariatric surgery patients.\n\nThe main hypothesis is that FreeO2 device for oxygen therapy associated with NIV or nasal high flow oxygen therapy (NHFOT) allows to reach better oxygenation and avoid hypoxemia and hyperoxia.",[92,93,94,95],"COPD Exacerbation","Oxygen Toxicity","Abdominal Obesity","Surgery","2025-08-27",{"date":98,"type":99},"2025-09-04","ACTUAL",{"date":101,"type":99},"2019-10-28",{"date":103,"type":86},"2028-06",{"name":71,"class":6},1]