Study objective: Morbid obesity is associated with adverse airway events including desaturation during deep sedation. Prior works have suggested that proprietary high-flow nasal cannula devices generate positive pressure to all airway structures and may be superior to standard (low-flow) nasal cannula for prevention of desaturation. We hypothesized that, at a similar fraction of inspired oxygen (FiO2), use of a High-Flow Nasal Cannula (HFNC) at maximum flow rate would result in a lower incidence of intra-procedural desaturation episodes in morbidly obese patients compared to standard nasal cannula (SNC) during deep sedation with propofol.
Design: This is a pragmatic, prospective, randomized clinical trial at one hospital (NCT03148262, UTSW#112016-058). Morbidly obese patients were randomized to HFNC during propofol sedation for colonoscopy. HFNC was performed using maximum flow rates of 60 liters per minute (LPM) and FiO2 of 0.36-0.40, whereas SNC was performed at 4LPM. The primary endpoint was incidence of arterial oxygen desaturation <90% measured by pulse oximetry. At midpoint enrollment the Data Monitoring Committee (DMC) performed a pre-planned O'Brien and Fleming futility test.
Main results: Patients were randomized to HFNC (n = 28) or SNC (n = 31). Interim analysis of the primary endpoint showed that the desaturation rates in the HFNC group (39.3%) and the SNC group (45.2%) were not significantly different (p = 0.79). The DMC halted the trial at that point due to futility.
Conclusion: At similar FiO2, HFNC was not significantly different from SNC for prevention of arterial oxygen desaturation in morbidly obese patients undergoing propofol sedation for colonoscopy.
Keywords: Colonoscopy; Deep sedation; High-flow nasal cannula; Morbid obesity.
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