Comparison of the Efficacy and Safety of the FDA-approved Intragastric Balloon Systems in a Clinical Setting.

BACKGROUND AND AIMS: The gas-filled intragastric balloon (IGB) system (Obalon) and the fluid-filled IGB system (Orbera) are the current FDA-approved IGB systems to treat obesity; however, they have not been previously compared in clinical practice. The aims of this study were to compare their efficacy, tolerance, and safety in a clinical setting. MATERIALS AND METHODS: This is a retrospective cohort study of consecutive patients treated with the gas-filled IGB or fluid-filled IGB between October 2015 and May 2020 at 2 academic centers. The primary endpoints included percent total body weight loss at balloon removal in patients who completed at least 20 weeks of therapy, the difference in adverse events that required urgent evaluation or hospitalization, and early removal in the 2 groups. RESULTS: A total of 87 patients underwent successful IGB placement (gas-filled IGB n=57, age 48.9±8.8, body mass index 35.5±5 kg/m 2 ; fluid-filled IGB n=30, age 49.2±14.3, body mass index 38.8±6 kg/m 2 ). Eleven patients underwent early device removal. There were no differences in percent total body weight loss at balloon removal and 12 months between the balloon systems ( P =0.39). Patients who received the fluid-filled IGB were more likely to require urgent evaluation or treatment, require hospital stay >24 hours, and need early balloon system removal compared with patients treated with the gas-filled IGB. CONCLUSION: In this 2-center cohort, both FDA-approved gastric balloon systems had the same effectiveness, but the gas-filled IGB had fewer serious adverse events and better tolerability than the fluid-filled IGB.

Implementation and Assessment of a Proning Protocol for Nonintubated Patients With COVID-19.

INTRODUCTION: The COVID-19 pandemic has caused over 1,250,000 deaths worldwide. With limited therapeutic options, proning nonintubated patients emerged as a safe and affordable intervention to manage hypoxemia. METHODS: A proning protocol to identify and prone eligible patients was implemented. Patients were encouraged to self-prone for 2-3 hours, 3 times daily. Investigators created educational materials for nurses and patients and developed a COVID-19-specific proning order within the electronic health record (EHR). Investigators completed an 800-person retrospective chart review to study the implementation of this protocol. RESULTS: From March 22, 2020, to June 5, 2020, 586 patients were admitted to the COVID-19 floor. Of these patients, 42.8% were eligible for proning. Common contraindications were lack of hypoxia, altered mental status, and fall risk. The proning protocol led to a significant improvement in provider awareness of patients appropriate for proning, increasing from 12% to 83%, as measured by placement of a proning order into the EHR. There was a significant improvement in all appropriate patients documented as proned, increasing from 18% to 45% of eligible patients. CONCLUSIONS: The creation of an effective hospital-wide proning protocol to address the exigencies of the COVID-19 pandemic is possible and may be accomplished in a short period of time.

Implementing Prone Positioning for COVID-19 Patients Outside the Intensive Care Unit.

BACKGROUND: Proning intubated intensive care unit patients for the management of acute respiratory distress syndrome is an accepted standard of practice. We examined the nursing climate in 4 units and its impact on implementing a novel self-proning protocol to treat COVID-19 patients outside the intensive care unit. LOCAL PROBLEM: Nursing units previously designated for medical/surgical populations had to adjust quickly to provide evidence-based care for COVID-19 patients attempting self-proning. METHODS: Nurses from 4 nursing units were surveyed about the implementation process on the self-proning protocol. Their perception of unit implementation was assessed via the Implementation Climate Scale. INTERVENTIONS: A new self-proning nursing protocol was implemented outside the intensive care unit. RESULTS: Consistent education on the protocol, belief in the effectiveness of the intervention, and a strong unit-based climate of evidence-based practice contributed to greater implementation of the protocol. CONCLUSIONS: Implementation of a new nursing protocol is possible with strong unit-based support, even during a pandemic.

Appropriateness and Safety of Direct Access Endoscopy in Hospitalized Patients.

Background and objective Direct access endoscopy (DAE) allows hospitalists to refer patients for endoscopy without a gastroenterologist (GI) evaluation, potentially decreasing wait time and facilitating earlier discharge from the hospital. This study aimed to evaluate the efficacy and safety of DAE for average-risk endoscopic procedures. Methods A retrospective chart review was performed by comparing patients who underwent a DAE with patients who underwent an endoscopy ordered by GI physicians at a tertiary care hospital. The procedure indications were obtained from the endoscopy reports and hospitalist progress notes. Appropriateness of each procedure was determined based on the guidelines from the American Society for Gastrointestinal Endoscopy (ASGE). Findings, procedure-related complications, and clinical significance were recorded. Results A total of 110 patients were included in this study; 40 were DAE and 70 were ordered by GI. The mean age of the patients was 55.5 years with 69 males and 41 females. In the DAE group, there were 31 esophagogastroduodenoscopies (EGD) and nine colonoscopies performed, while in the GI group, there were 58 EGDs, 11 colonoscopies, and one push enteroscopy. All procedures fulfilled ASGE criteria; 20/40 DAE and 53/70 GI-ordered procedures had clinically significant findings. There was one complication in each group. Conclusion DAE allows a hospitalist to order an endoscopy without consultation with a GI physician. This study showed that all DAE procedures had met ASGE criteria for appropriateness, with 50% having clinically significant findings and no difference in adverse events. These results suggest that DAE is safe and effective in evaluating hospitalized patients for average-risk endoscopy.