[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632597":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":43,"centralContacts":47,"locations":56,"responsibleParty":75,"collaborators":36,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":36,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":36,"enrollmentInfo":87,"targetDuration":36,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":103,"whyStopped":36,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University of Utah","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Continuous Oxygen Flow","ACTIVE_COMPARATOR","This arm is the traditional supplemental oxygen delivery of providing a continuous oxygen flow through a nasal cannula or non-rebreather oxygen mask at a flow rate set by the anesthetist.",[13],"Device: Control",{"label":15,"type":16,"description":17,"interventionNames":18},"Synchronized Oxygen Flow","EXPERIMENTAL","This arm is breath-synchronized oxygen delivery with the FDA-cleared Sovant oxygen delivery device through a nasal cannula or non-rebreather mask. Oxygen is pulsed at the beginning of the patient's inhalation and flow is discontinued the rest of the breath.",[19],"Device: Breath-synchronized oxygen",{"label":21,"type":16,"description":22,"interventionNames":23},"CPAP","This arm is oxygen delivery through continuous positive airway pressure (CPAP) therapy administered by an investigational device, where oxygen is given through a tight-fitting mask over the patient's mouth and nose. The oxygen flow rate is automatically adjusted by the device to maintain a set pressure in the patient's airway as selected by the anesthetist.",[24],"Device: CPAP",[26,33,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Breath-synchronized oxygen","This is breath-synchronized oxygen delivery of supplemental oxygen by the FDA-cleared Sovant device, where oxygen is given synchronously with the patient's inhalation only through a nasal cannula or non-rebreather oxygen mask.",[15],[32],"Synchronized Flow",{"type":27,"name":21,"description":34,"armGroupLabels":35,"otherNames":36},"Supplemental oxygen delivered via continuous positive airway pressure (CPAP) therapy through a tight-fitting mask over the patient's mouth and nose, where oxygen flow rate is automatically adjusted by the investigational devce to maintain the anesthetist-selected airway pressure.",[21],null,{"type":27,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Control","This is the traditional approach of administering oxygen at a constant flow rate chosen by the anesthetist through a nasal cannula or non-rebreather oxygen mask.",[9],[42],"Continuous flow",[44],{"name":45,"affiliation":5,"role":46},"Kai Kuck, PhD","PRINCIPAL_INVESTIGATOR",[48,52],{"name":45,"role":49,"phone":50,"phoneExt":36,"email":51},"CONTACT","(801) 581-6393","kai.kuck@hsc.utah.edu",{"name":53,"role":49,"phone":54,"phoneExt":36,"email":55},"Trey S Blackwell, MS","(801) 395-4038","Trey.Blackwell@utah.edu",[57],{"facility":58,"status":36,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"University of Utah South Jordan Health Center - Endoscopy","South Jordan","Utah","84009","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-111.92966,40.56217,{"lat":68,"lon":67},[71],{"name":72,"role":49,"phone":73,"phoneExt":36,"email":74},"Kate Koniuch, MD","801-213-4500","Kate.Koniuch@hsc.utah.edu",{"type":76,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100632597","supplemental-oxygen-and-oxygen-desaturations-in-colonoscopies-100632597",false,"NCT07515755","Supplemental Oxygen and Oxygen Desaturations in Colonoscopies","Evaluation of Oxygen Desaturation and Apnea Events With Supplemental Oxygen During Procedural Sedation in Colonoscopies","Inclusion Criteria:\n\n* Adult patient\n* No life threatening conditions\n* Undergoing colonoscopy procedures and receiving procedural sedation at the University of Utah Health clinic in South Jordan, Utah.\n\nExclusion Criteria:\n\n* Inability\u002Frefusal of subject to provide informed consent.\n* Less than 18 years of age.\n* Standard colonoscopy exclusion criteria used at the GI lab at the University of Utah.\n* Patients known or suspected to be pregnant.\n* Patients with an ASA physical status of IV (A patient with severe systemic disease that is a constant threat to life) or V (A moribund patient who is not expected to survive without the operation).\n* Patients known to have acute respiratory distress syndrome, severe COPD, or cardiovascular disease.\n* If their oxygen saturation measured by pulse oximetry (SpO2) is below 93% while breathing room air prior to the procedure.\n* Patients with severe medical condition(s) that in the view of the acting physician prohibits participation in the study.",true,"ALL","18 Years",{"count":88,"type":89},280,"ESTIMATED","INTERVENTIONAL",[92],"NA","This study will compare apnea and oxygen desaturation events among various methods of supplemental oxygen delivery during procedural sedation in colonoscopy patients. The goals of the study are to track apnea (10 or more seconds without respiration) and oxygen desaturation (hemoglobin oxygen saturation less than 90%) events in colonoscopy patients receiving one of three different methods of supplemental oxygen administration. The first method is standard-of-care continuous flow oxygen therapy, where a constant flow of oxygen is administered through a nasal cannula or oxygen mask. The second method is synchronized flow oxygen therapy. This is a delivery method implemented in an FDA-cleared medical device (Sovant, Dynasthetics LLC) which delivers variable-volume oxygen pulses only as the patient inhales. The delivered oxygen pulses are commensurate to the set flow rate and the patient's respiratory rate. The third method is continuous positive airway pressure therapy (CPAP), where non-invasive pressure support is given to the patient's airway to help keep their airway open. The hypothesis being tested is that synchronized flow delivery and CPAP therapy will demonstrate reductions in apnea and oxygen desaturation events compared to traditional continuous flow oxygen therapy.",[95,96,97],"Oxygen Desaturation","Apnea (Central and Obstructive)","Airway Obstruction",[21,99,100,101,102],"apnea","desaturation","sedation","colonoscopy","NOT_YET_RECRUITING","2026-03-31",{"date":106,"type":107},"2026-04-07","ACTUAL",{"date":109,"type":89},"2026-05-18",{"date":111,"type":89},"2026-12-31",{"name":5,"class":6},1]