High-flow versus standard nasal cannula in morbidly obese patients during colonoscopy: A prospective, randomized clinical trial.

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.

Phase I Trial of sequential administration of recombinant DNA and adenovirus expressing L523S protein in early stage non-small-cell lung cancer.

L523S is an immunogenic lung cancer antigen that has demonstrated preclinical safety when the gene is injected intramuscularly as an expressive plasmid (pVAX/L523S) and when delivered following incorporation into an E1B-deleted adenovirus (Ad/L523S). We performed a phase I clinical trial in 13 stage IB, IIA, and IIB non-small-cell lung cancer patients. pVAX/L523S (8 mg on days 0 and 14 in all cohorts) and Ad/L523S (1, 20, 400 x 10(9) vp on days 28 and 56, cohorts 1, 2, and 3, respectively) were administered to 3 patients in each of three cohorts. No significant toxic effect was identified. All but 1 patient demonstrated greater than or equal to twofold elevation in anti-adenovirus antibodies. One of 10 evaluable patients demonstrated L523S-specific antibody by direct IgG ELISA. Two patients developed disease recurrence and all remain alive after a median of 290 days follow-up. Results suggest a high level of safety but evidence of L523S-directed immune activation was limited, suggesting a need for modification of dose, schedule, and site of vaccination (i.e., intradermal) with further clinical testing.