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NCT05754255
Comparison of High-flow Oxygen With or Without Nasal Positive Airway Pressure (PAP) During Propofol Sedation for Colonoscopy in an Ambulatory Surgical Center
Conditions: Colonoscopy, Positive-Pressure Respiration
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 190
Sponsor: Indiana University
Location: United States
Summary
The primary objective of the prospective study is to compare the incidence, duration, and severity of oxygen desaturation in high-risk patients randomized to nasal mask with nasal positive airway pressure (PAP) or standard care (nasal cannula) receiving propofol sedation during colonoscopy in an ambulatory surgical center (ASC).Patients will be randomized in groups of ten to one of two groups using a random number table.Group A: standard care with a nasal cannula.
Group B: SuperNO2VA™EtCO2.
Following the procedure subjects will be asked to complete satisfaction surveys before leaving the ASC and 48 +/- hours following their procedure.Researchers will compare levels of satisfaction and levels of oxygen saturation.
Eligibility Criteria
Inclusion Criteria:Age 18 years of age or olderPatients undergoing upper colonoscopyAmerican Society of Anesthesiology (ASA) Physical Status I-IIIBMI ≥35 kg/m2 or documented Obstructive Sleep ApneaHas provided written informed consentExclusion Criteria:Inpatient statusActive Congestive Heart Failure ExacerbationUntreated ischemic heart diseaseAcute exacerbation of respiratory disorders, including COPD and asthmaEmergent proceduresPregnancyPrevious enrollment in this studyInability to provide informed consentAdditional medical testing planned for the same dayHistory of allergic reaction to propofolTracheostomySupra-glottic or sub-glottic tumorGastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon).Known obstructing lesion or narrowing of the colonPrevious colon surgeryPrevious failed or unsuccessfully completed colonoscopy
Source: ClinicalTrials.gov (NCT05754255). StuddyBuddy aggregates publicly available trial information.