Efficacy of Ninjin'yoeito in treating severe coronavirus disease 2019 in patients in an intensive care unit.

Coronavirus Disease-2019 (COVID-19), an infectious disease associated with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), is a global emergency with high mortality. There are few effective treatments, and many severe patients are treated in an intensive care unit (ICU). The purpose of this study was to evaluate whether the Japanese Kampo medicine ninjin'yoeito (NYT) is effective in treating ICU patients with COVID-19. Nine patients with confirmed SARS-CoV-2 infection admitted to the ICU were enrolled in this study. All patients underwent respiratory management with invasive mechanical ventilation (IMV) and enteral nutrition. Four patients received NYT (7.5 g daily) from an elemental diet tube. We retrospectively examined the prognostic nutritional index (PNI), length of IMV, length of ICU stay, length of hospital stay, rate of tracheostomy, and mortality rate. The median age of the enrolled participants was 60.0 years (4 men and 5 women). The median body mass index was 27.6. The most common comorbidity was diabetes (4 patients, 44%), followed by hypertension (3 patients, 33%) and chronic kidney disease (2 patients, 22%). The median length of IMV, ICU stay, and hospital stay were all shorter in the NYT group than in the non-NYT group (IMV; 4.0 days vs 14.3 days, ICU; 5.3 days vs 14.5 days, hospital stay; 19.9 days vs 28.2 days). In the NYT and non-NYT groups, the median PNI at admission was 29.0 and 31.2, respectively. One week after admission, the PNI was 30.7 in the NYT group and 24.4 in non-NYT group. PNI was significantly (p = 0.032) increased in the NYT group (+13.6%) than in the non-NYT group (-22.0%). The Japanese Kampo medicine NYT might be useful for treating patients with severe COVID-19 in ICU. This study was conducted in a small number of cases, and further large clinical trials are necessary.

Can the global end-diastolic volume index guide fluid management in septic patients? A multicenter randomized controlled trial.

AIM: An index that accurately measures intravascular volume is paramount for the optimal resuscitation of sepsis. Selecting an adequate indicator to substitute for central venous pressure (CVP) has remained an issue. The objective of our study was to compare the usefulness of standard early goal-directed therapy (EGDT) with CVP (EGDT-CVP) and modified EGDT with global end-diastolic volume index (GEDI; EGDT-GEDI) for sepsis. METHODS: This was a multicenter prospective randomized controlled study. All patients with sepsis who were expected to require mechanical ventilator support for a minimum of 48 h were included. The patients were classified into an EGDT-CVP group and an EGDT-GEDI group. All participants underwent the extubation protocol. The primary outcome was the ventilator-free days over a 28-day period. RESULTS: The ventilator-free days was not significantly different between the two groups (P = 0.59). However, the EGDT-GEDI group showed a trend of shorter ventilator support duration (5.1 days [2.0-8.7 days] versus 3.9 days [2.4-5.7 days], P = 0.27) and length of stay in the intensive care unit (7.2 days [3.8-10.7 days] versus 5.1 days [3.7-8.8 days], P = 0.05) and a smaller 3-day infusion balance than the EGDT-CVP group (4,405 mL [1,092-8,163 mL] versus 3,046 mL [830-6,806 mL], P = 0.34), but the differences were not statistically significant. CONCLUSION: Although there was no significant efficacy, EGDT guided by GEDI showed a trend of shorter length of stay in the intensive care unit and lower 3-day infusion balance than the EGDT-CVP group in sepsis. The GEDI monitoring did not appear to improve the ventilator-free days over a 28-day period.

Association between repeated intubation attempts and adverse events in emergency departments: an analysis of a multicenter prospective observational study.

STUDY OBJECTIVE: Although repeated intubation attempts are believed to contribute to patient morbidity, only limited data characterize the association between the number of emergency department (ED) laryngoscopic attempts and adverse events. We seek to determine whether multiple ED intubation attempts are associated with an increased risk of adverse events. METHODS: We conducted an analysis of a multicenter prospective registry of 11 Japanese EDs between April 2010 and September 2011. All patients undergoing emergency intubation with direct laryngoscopy as the initial device were included. The primary exposure was multiple intubation attempts, defined as intubation efforts requiring greater than or equal to 3 laryngoscopies. The primary outcome measure was the occurrence of intubation-related adverse events in the ED, including cardiac arrest, dysrhythmia, hypotension, hypoxemia, unrecognized esophageal intubation, regurgitation, airway trauma, dental or lip trauma, and mainstem bronchus intubation. RESULTS: Of 2,616 patients, 280 (11%) required greater than or equal to 3 intubation attempts. Compared with patients requiring 2 or fewer intubation attempts, patients undergoing multiple attempts exhibited a higher adverse event rate (35% versus 9%). After adjusting for age, sex, principal indication, method, medication, and operator characteristics, intubations requiring multiple attempts were associated with an increased odds of adverse events (odds ratio 4.5; 95% confidence interval 3.4 to 6.1). CONCLUSION: In this large Japanese multicenter study of ED patients undergoing intubation, we found that multiple intubation attempts were independently associated with increased adverse events.