A comparison study of temporal trends of SARS-CoV2 RNAemia and biomarkers to predict success and failure of high flow oxygen therapy among patients with moderate to severe COVID-19.

Optimal timing for intubating patients with coronavirus disease 2019 (COVID-19) has been debated throughout the pandemic. Early use of high-flow nasal cannula (HFNC) can help reduce the need for intubation, but delay can result in poorer outcomes. This study examines trends in laboratory parameters and serum severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA levels of patients with COVID-19 in relation to HFNC failure. Patients requiring HFNC within three days of hospitalization between July 1 and September 30, 2021 were enrolled. The primary outcome was HFNC failure (early failure ≤Day 3; late failure ≥Day 4), defined as transfer to intensive care just before/after intubation or in-hospital death. We examined changes in laboratory markers and SARS-CoV2-RNAemia on Days 1, 4, and 7, together with demographic data, oxygenation status, and therapeutic agents. We conducted a univariate logistic regression with the explanatory variables defined as 10% change rate in each laboratory marker from Day 1 to 4. We utilized the log-rank test to assess the differences in HFNC failure rates, stratified based on the presence of SARS-CoV2 RNAemia. Among 122 patients, 17 (13.9%) experienced HFNC failure (early: n = 6, late: n = 11). Seventy-five patients (61.5%) showed an initial SpO2/FiO2 ratio ≤243, equivalent to PaO2/FiO2 ratio ≤200, and the initial SpO2/FiO2 ratio was significantly lower in the failure group (184 vs. 218, p = 0.018). Among the laboratory markers, a 10% increase from Day 1 to 4 of lactate dehydrogenase (LDH) and interleukin (IL)-6 was associated with late failure (Odds ratio [OR]: 1.42, 95% confidence interval [CI]: 1.09-1.89 and OR: 1.04, 95%CI: 1.00-1.19, respectively). Furthermore, in patients with persistent RNAemia on Day 4 or 7, the risk of late HFNC failure was significantly higher (Log-rank test, p<0.01). In conclusion, upward trends in LDH and IL-6 levels and the persistent RNAemia even after treatment were associated with HFNC failure.

Analysis of adverse events related to extracorporeal membrane oxygenation from a nationwide database of patient-safety accidents in Japan.

Although adverse events related to extracorporeal membrane oxygenation have been reported, epidemiological data on life-threatening events are insufficient to study the causes of such adverse events. Data from the Japan Council for Quality Health Care database were retrospectively analyzed. The adverse events extracted from this national database included events associated with extracorporeal membrane oxygenation reported between January 2010 and December 2021. We identified 178 adverse events related to extracorporeal membrane oxygenation. At least 41 (23%) and 47 (26%) accidents resulted in death and residual disability, respectively. The most common adverse events were cannula malposition (28%), decannulation (19%), and bleeding (15%). Among patients with cannula malposition, 38% did not undergo fluoroscopy-guided or ultrasound-guided cannulation, 54% required surgical treatment, and 18% required trans-arterial embolization. In this epidemiological study in Japan, 23% of the adverse events related to extracorporeal membrane oxygenation had fatal outcomes. Our findings suggest that a training system for cannulation techniques may be needed, and hospitals offering extracorporeal membrane oxygenation should perform emergency surgeries.

Characteristics and in-hospital mortality of patients with COVID-19 from the first to fifth waves of the pandemic in 2020 and 2021 in the Japanese Medical Data Vision database.

Objectives: We aimed to describe patient characteristics, healthcare utilization, and in-hospital mortality among patients with COVID-19 in Japan across waves. Methods: Using a large-scale hospital-based database, we identified patients hospitalized for COVID-19 in the first (January-June 2020), second (June-October 2020), third (October 2020-February 2021), fourth (March-June 2021), and fifth (June-December 2021) waves. We summarized patient characteristics, healthcare utilization, and in-hospital mortality during each wave and performed multivariable logistic regression analyses for in-hospital mortality. Results: From the first to fifth waves, the number of patients (mean age ± standard deviation, years) was 2958 (61.2 ± 22.8), 7981 (55.6 ± 25.3), 18,788 (63.6 ± 22.9), 17,729 (60.6 ± 22.6), and 23,656 (51.2 ± 22.3), respectively. There were 190 (6.4%), 363 (4.5%), 1261 (6.7%), 1081 (6.1%), and 762 (3.2%) in-hospital deaths, respectively. The adjusted odds ratios for in-hospital deaths (95% confidence interval) were 0.78 (0.65-0.95), 0.94 (0.79-1.12), 0.99 (0.84-1.18), 0.77 (0.65-0.92), in the second to fifth waves, respectively, compared with the first wave. Conclusions: In-hospital COVID-19 mortality improved from the first to the second wave; however, during the third and fourth waves, mortality was as serious as in the first wave. Although in-hospital mortality during the fifth wave improved, careful monitoring is needed for upcoming waves, considering changing patient and viral characteristics.

Machine learning-based prognostic modeling of patients with acute heart failure receiving furosemide in intensive care units.

Purpose: This study developed machine learning models to predict in-hospital mortality, initiation of acute renal replacement therapy, and mechanical ventilation in patients with acute heart failure receiving furosemide in intensive care units. Method: An extensive database comprising static and dynamic features obtained from a Japanese hospital chain was used to construct and train the machine learning models. Results: The results revealed that the proposed machine learning models predict in-hospital mortality, initiation of acute renal replacement therapy, and mechanical ventilation with good accuracy. However, the optimal models vary depending on the predicted outcomes. The linear support vector machine classification models exhibited the highest in-hospital mortality and mechanical ventilation prediction accuracy, with the area under the receiver operating characteristic curve of 0.73 and 0.73, respectively, whereas the multi-layer neural network exhibited the highest accuracy for acute renal replacement therapy initiation prediction with an area under the receiver operating characteristic curve of 0.70. Conclusions: In conclusion, this study demonstrated that machine learning models could help predict the clinical outcomes of patients with acute heart failure receiving furosemide. However, the optimal models may differ depending on the outcome of interest.

Circulating Extracellular Vesicle Levels in Patients with Coronavirus Disease 2019 Coagulopathy: A Prospective Cohort Study.

Coronavirus disease 2019 (COVID-19) is associated with coagulopathy. However, the underlying mechanisms are not completely understood. We evaluated the association between COVID-19 coagulopathy and extracellular vesicle (EV) levels. We hypothesized that several EV levels would be higher in COVID-19 coagulopathy patients than in non-coagulopathy patients. This prospective observational study was conducted in four tertiary care faculties in Japan. We enrolled 99 COVID-19 patients (48 with coagulopathy and 51 without coagulopathy) aged ≥20 years who required hospitalization, and 10 healthy volunteers; we divided the patients into coagulopathy and non-coagulopathy groups according to the D-dimer levels (≥1 µg/mL and <1 µg/mL, respectively). We used flow cytometry to measure the tissue-factor-bearing, endothelium-derived, platelet-derived, monocyte-derived, and neutrophil-derived EV levels in platelet-free plasma. The EV levels were compared between the two COVID-19 groups as well as among the coagulopathy patients, non-coagulopathy patients, and healthy volunteers. No significant difference was found in EV levels between the two groups. Meanwhile, the cluster of differentiation (CD) 41 + EV levels were significantly higher in COVID-19 coagulopathy patients than in healthy volunteers (549.90 [255.05-984.65] vs. 184.3 [150.1-254.1] counts/µL, p = 0.011). Therefore, CD41+ EVs might play an essential role in COVID-19 coagulopathy development.

Successful treatment of invasive tracheobronchial pulmonary aspergillosis with venovenous extracorporeal membrane oxygenation and combined systemic, intratracheal instillation of liposomal amphotericin B: a case report.

BACKGROUND: Invasive pulmonary Aspergillus and invasive bronchial aspergillosis is a life-threatening opportunistic fungal infection that predominantly affects immunocompromised hosts. A case series and review found that the mortality rate of invasive bronchial aspergillosis is high, at about 40%, and 23.7% of invasive bronchial aspergillosis patients require mechanical ventilator management. There are few reports of life-saving cases with venovenous extracorporeal membrane oxygenation as rescue therapy in invasive pulmonary Aspergillus and invasive bronchial aspergillosis. Here, we report a case of invasive bronchial aspergillosis and invasive pulmonary Aspergillus that was successfully treated with venovenous extracorporeal membrane oxygenation, and combined systemic and intratracheal instillation of liposomal amphotericin B. CASE PRESENTATION: We present the case of a 61-year-old Japanese man with invasive tracheobronchial-pulmonary aspergillosis while receiving chemotherapy for malignant lymphoma. Bronchoscopy revealed trachea covered with pseudomembranous necrotizing tissue, the culture revealed Aspergillus fumigatus, and the histological findings of pseudomembranous revealed fungal hyphae. The patient required venovenous extracorporeal membrane oxygenation because of respiratory failure for atelectasis and obstructive pneumoniae. While continuing systemic administration of liposomal amphotericin B, intratracheal instillation liposomal amphotericin B was performed by bronchoscopy three times a week. Although the respiratory conditions improved and the patient was discontinued on venovenous extracorporeal membrane oxygenation, he ultimately died of recurrence of malignant lymphoma. CONCLUSION: Intratracheal instillation of liposomal amphotericin B is safe, and liposomal amphotericin B instillation allowed a targeted high local drug concentration, which led to improvement in the invasive bronchial aspergillosis. In addition, since the patient was supported with venovenous extracorporeal membrane oxygenation, we were able to perform safe bronchoscopic debridement of airway lesions and intratracheal instillation of liposomal amphotericin B.

Newly developed artificial intelligence algorithm for COVID-19 pneumonia: utility of quantitative CT texture analysis for prediction of favipiravir treatment effect.

PURPOSE: Using CT findings from a prospective, randomized, open-label multicenter trial of favipiravir treatment of COVID-19 patients, the purpose of this study was to compare the utility of machine learning (ML)-based algorithm with that of CT-determined disease severity score and time from disease onset to CT (i.e., time until CT) in this setting. MATERIALS AND METHODS: From March to May 2020, 32 COVID-19 patients underwent initial chest CT before enrollment were evaluated in this study. Eighteen patients were randomized to start favipiravir on day 1 (early treatment group), and 14 patients on day 6 of study participation (late treatment group). In this study, percentages of ground-glass opacity (GGO), reticulation, consolidation, emphysema, honeycomb, and nodular lesion volumes were calculated as quantitative indexes by means of the software, while CT-determined disease severity was also visually scored. Next, univariate and stepwise regression analyses were performed to determine relationships between quantitative indexes and time until CT. Moreover, patient outcomes determined as viral clearance in the first 6 days and duration of fever were compared for those who started therapy within 4, 5, or 6 days as time until CT and those who started later by means of the Kaplan-Meier method followed by Wilcoxon's signed-rank test. RESULTS: % GGO and % consolidation showed significant correlations with time until CT (p < 0.05), and stepwise regression analyses identified both indexes as significant descriptors for time until CT (p < 0.05). When divided all patients between time until CT of 4 days and that of more than 4 days, accuracy of the combined quantitative method (87.5%) was significantly higher than that of the CT disease severity score (62.5%, p = 0.008). CONCLUSION: ML-based CT texture analysis is equally or more useful for predicting time until CT for favipiravir treatment on COVID-19 patients than CT disease severity score.

Association between pre-admission anticoagulation and in-hospital death, venous thromboembolism, and major bleeding among hospitalized COVID-19 patients in Japan.

PURPOSE: The coagulation activation leads to thrombotic complications such as venous thromboembolism (VTE) in patients with coronavirus disease-2019 (COVID-19). Prophylactic anticoagulation therapy has been recommended for hospitalized COVID-19 patients in clinical guidelines. This retrospective cohort study aimed to examine the association between pre-admission anticoagulation treatment and three outcomes: in-hospital death, VTE, and major bleeding among hospitalized COVID-19 patients in Japan. METHODS: Using a large-scale claims database built by the Medical Data Vision Co. in Japan, we identified patients hospitalized for COVID-19 who had outpatient prescription data at least once within 3 months before being hospitalized. Exposure was set as pre-admission anticoagulation treatment (direct oral anticoagulant or vitamin K antagonist), and outcomes were in-hospital death, VTE, and major bleeding. We conducted multivariable logistic regression analyses, adjusting for a single summarized score (a propensity score of receiving pre-admission anticoagulation) for VTE and major bleeding, due to the small number of outcomes. RESULTS: Among the 2612 analytic patients, 179 (6.9%) had pre-admission anticoagulation. Crude incidence proportions were 13.4% versus 8.5% for in-hospital death, 0.56% versus 0.58% for VTE, and 2.2% versus 1.1% for major bleeding among patients with and without pre-admission anticoagulation, respectively. Adjusted odds ratios (95% confidence intervals) were 1.25 (0.75-2.08) for in-hospital death, 0.21 (0.02-1.97) for VTE, and 2.63 (0.80-8.65) for major bleeding. Several sensitivity analyses did not change the results. CONCLUSIONS: We found no evidence that pre-admission anticoagulation treatment was associated with in-hospital death. However, a larger sample size may be needed to conclude its effect on VTE and major bleeding.

Comparison of patient characteristics and in-hospital mortality between patients with COVID-19 in 2020 and those with influenza in 2017-2020: a multicenter, retrospective cohort study in Japan.

BACKGROUND: COVID-19 has worse mortality than influenza in American and European studies, but evidence from the Western Pacific region is scarce. METHODS: Using a large-scale multicenter inpatient claims data in Japan, we identified individuals hospitalised with COVID-19 in 2020 or influenza in 2017-2020. We compared patient characteristics, supportive care, and in-hospital mortality, with multivariable logistic regression analyses for in-hospital mortality overall, by age group, and among patients with mechanical ventilation. FINDINGS: We identified 16,790 COVID-19 patients and 27,870 influenza patients, with the different age distribution (peak at 70-89 years in COVID-19 vs. bimodal peaks at 0-9 and 80-89 years in influenza). On admission, the use of mechanical ventilation was similar in both groups (1·4% vs. 1·4%) but higher in the COVID-19 group (3·3% vs. 2·5%; p<0·0001) during the entire hospitalisation. The crude in-hospital mortality was 5·1% (856/16,790) for COVID-19 and 2·8% (791/27,870) for influenza. Adjusted for potential confounders, the in-hospital mortality was higher for COVID-19 than for influenza (adjusted odds ratio [aOR] 1·83, 95% confidence interval [CI] 1·64-2·04). In age-stratified analyses, the aOR (95%CI) were 0·78 (0·56-1·08) and 2·05 (1·83-2·30) in patients aged 20-69 years and ≥70 years, respectively (p-for-interaction<0·0001). Among patients with mechanical ventilation, the aOR was 0·79 (0·59-1·05). INTERPRETATION: Patients hospitalised with COVID-19 in Japan were more likely to die than those with influenza. However, this was mainly driven by findings in older people, and there was no difference once mechanical ventilation was started. FUNDING: Ministry of Health, Labour and Welfare of Japan (21AA2007).

Adverse events related to thoracentesis and chest tube insertion: evaluation of the national collection of subject safety incidents in Japan.

PURPOSE: Thoracentesis and chest tube insertion are procedures commonly performed in routine clinical practice and are considered mandatory skills for all physicians. Adverse events secondary to these procedures have been widely reported; however, epidemiology data concerning life-threatening events associated with these procedures are lacking. METHODS: We retrospectively analyzed data from the Japan Council for Quality Health Care open database regarding subject safety incidents involving thoracentesis and chest tube insertion. The adverse events extracted from the database included only events associated with thoracentesis and chest tube insertion reported between January 2010 and April 2020. RESULTS: We identified 137 adverse events due to thoracentesis or chest tube insertion. Our analysis also revealed at least 15 fatal adverse events and 17 cases of left/right misalignment. Not only resident doctors but also physicians with 10 years or more of clinical experience had been mentioned in these reports. The most common complications due to adverse events were lung injury (55%), thoracic vascular injury (21%), and liver injury (10%). Surgical treatment was required for 43 (31%) of the 137 cases, and the mortality risk was significantly higher for thoracic vascular injury than for other complications (p = 0.02). CONCLUSION: We identified at least 15 fatal adverse events and 17 cases of left/right misalignment over a 10-year period in the Japan Council for Quality Health Care open database. Our findings also suggest that care should be taken to avoid thoracic vascular injury during chest tube insertion and that immediate intervention is required should such an injury occur.

Spontaneous pneumothorax with coronavirus disease 2019 in non-ventilated patients: A single-center retrospective case series.

BACKGROUND: Pneumothorax is a rare complication of coronavirus disease 2019, and many of its associated factors are related to mechanical ventilation. We investigated the incidence and clinical features of patients with pneumothorax and coronavirus disease 2019 at a field hospital for patients who did not require intubation. MATERIALS AND METHODS: An isolated field hospital for COVID-19 patients who did not require ventilation was constructed. Patients who developed pneumothorax were extracted and reviewed retrospectively. RESULTS: Between May 2020 and February 2021, 1061 patients were admitted to this field hospital. Among them, eight patients (0.75%, three men and four women) developed pneumothorax. The mean age at incidence was 79.9 (range: 20-96) years; all patients were over the age of 80 years, except one 20-year-old woman. Six of these eight patients (75%) died. CONCLUSION: Although pneumothorax is a rare complication of coronavirus disease-2019, it is predictive of a poor prognosis in older-adult patients.

Impact of non-pharmaceutical interventions for the COVID-19 pandemic on emergency department patient trends in Japan: a retrospective analysis.

AIM: The coronavirus disease (COVID-19) pandemic massively impacted emergency department (ED) visits. The unavailability of specific therapies or vaccines has made non-pharmaceutical interventions (NPIs) an alternative strategy for COVID-19. We assessed the impact of NPIs (nationwide school closures and state of emergency) on ED visits during the COVID-19 pandemic in Japan. METHODS: This retrospective study compared the trends in ED visits from 1 January to 25 May, 2020 (during the pandemic) with the average during 2015-2019 (before the pandemic). The primary end-point was the change in the number of ED visits during the COVID-19 pandemic with those from before the pandemic, with the NPI application stratified across four periods in 2020: Period 0 (1-15 January), no COVID-19 cases detected in Japan; Period I (16 January-1 March), initial COVID-19 outbreak; Period II (2 March-15 April), nationwide school closures; Period III (16 April-25 May), state of emergency. RESULTS: Compared with before the pandemic, the number of walk-in ED visits significantly decreased by 23.1%, 12.4%, and 24.0% (4,047 versus 3,111; 3,211 versus 2,813; and 3,384 versus 2,573; P < 0.001 for all) in Periods I, II, and III, respectively. The number of ambulance ED visits during the pandemic significantly increased by 8.3% in Period I (1,814 versus 1,964, P = 0.002), whereas there was no significant change in Periods II and III with 2.7% and -3.1% (1,547 versus 1,589 and 1,389 versus 1,346; P = 0.335 and P = 0.284, respectively). CONCLUSIONS: The application of an NPI during the COVID-19 pandemic could have significantly reduced patient attendance in the ED.

Retrospective Study of Acute Kidney Injury Incidence in Patients with Newly Diagnosed Acute Promyelocytic Leukemia.

PURPOSE: Acute promyelocytic leukemia (APL) constitutes 5-10% of all cases of newly diagnosed acute myeloid leukemia. However, data on the epidemiology and risk factors for acute kidney injury (AKI) in patients with newly diagnosed APL are lacking. This study determined the incidence rate of AKI during induction chemotherapy for patients with newly diagnosed APL and the risk factors for AKI. PATIENTS AND METHODS: We conducted a retrospective observational study of patients with newly diagnosed APL in the Shonan Kamakura General Hospital between April 2004 and April 2020. Data of 27 patients with newly diagnosed APL were analyzed. The patients were classified as no AKI and AKI stages 1, 2 or 3. RESULTS: The incidence rate of AKI during induction chemotherapy was 40% (11/27). Among patients who developed AKI, four patients experienced AKI stage 3, and two patients required renal replacement therapy. No significant differences were found in the white blood cell count and baseline renal function between the groups; however, D-dimer and C-reactive protein levels upon admission were significantly higher in patients with AKI than in patients without AKI. Among patients who developed AKI, in hospital mortality at 90 days was 36% (4/11), which was significantly higher than among patients without AKI (p = 0.02). Patients who developed AKI were administered vancomycin more frequently, while almost all blood culture results were negative. CONCLUSION: Incidence of AKI development in patients with newly diagnosed APL during induction chemotherapy was approximately 40%. Moreover, patients who developed AKI tended to be administered vancomycin more frequently. Unnecessary use of vancomycin should be avoided in patients with newly diagnosed APL, and using alternative non-nephrotoxic drugs should be considered for patients at risk of AKI.

A Prospective, Randomized, Open-Label Trial of Early versus Late Favipiravir Therapy in Hospitalized Patients with COVID-19.

Favipiravir is an oral broad-spectrum inhibitor of viral RNA-dependent RNA polymerase that is approved for treatment of influenza in Japan. We conducted a prospective, randomized, open-label, multicenter trial of favipiravir for the treatment of COVID-19 at 25 hospitals across Japan. Eligible patients were adolescents and adults admitted with COVID-19 who were asymptomatic or mildly ill and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients were randomly assigned at a 1:1 ratio to early or late favipiravir therapy (in the latter case, the same regimen starting on day 6 instead of day 1). The primary endpoint was viral clearance by day 6. The secondary endpoint was change in viral load by day 6. Exploratory endpoints included time to defervescence and resolution of symptoms. Eighty-nine patients were enrolled, of whom 69 were virologically evaluable. Viral clearance occurred within 6 days in 66.7% and 56.1% of the early and late treatment groups (adjusted hazard ratio [aHR], 1.42; 95% confidence interval [95% CI], 0.76 to 2.62). Of 30 patients who had a fever (≥37.5°C) on day 1, times to defervescence were 2.1 days and 3.2 days in the early and late treatment groups (aHR, 1.88; 95% CI, 0.81 to 4.35). During therapy, 84.1% developed transient hyperuricemia. Favipiravir did not significantly improve viral clearance as measured by reverse transcription-PCR (RT-PCR) by day 6 but was associated with numerical reduction in time to defervescence. Neither disease progression nor death occurred in any of the patients in either treatment group during the 28-day participation. (This study has been registered with the Japan Registry of Clinical Trials under number jRCTs041190120.).

[Successful lung transplantation after long-term ventilator and extracorporeal membrane oxygenation support in a patient with severe bronchiolitis obliterans following allogeneic bone marrow transplantation].

A 29-year-old man was diagnosed with acute myeloid leukemia at 20 years of age; he achieved a second complete remission at 22 years of age after an allogeneic unrelated bone marrow transplantation. After 14 months, he developed bronchiolitis obliterans (BO) due to chronic graft-versus-host disease. Home ventilator management was continuously performed for 3 years, but the patient required extracorporeal membrane oxygenation (ECMO) after progression to type 2 respiratory failure. A matched brain-dead lung donor was found after 5 months of intensive care management on ECMO, and bilateral lung transplantation was successfully performed. BO is a progressive refractory respiratory disease with poor prognosis. Careful management of infection, monitoring organ function, and lung transplantation at the appropriate time of initiation of mechanical ventilation or ECMO may save a patient's life. However, it is crucial to collaborate with higher education institutions or medical professionals in other departments.

Frequency of vital sign measurement among intubated patients in the general ward and nurses' attitudes toward vital sign measurement.

PURPOSE: The lack of recognition of respiratory distress may result in emergency tracheal intubation in the general ward. However, few studies have examined the differences in the frequency of vital sign measurement between patients with and without emergency tracheal intubation in the general ward. Thus, this study aimed to investigate the differences in the frequency of vital sign measurements between patients with and without emergency tracheal intubation. PATIENTS AND METHODS: This is a single-center, retrospective, observational study of unplanned intensive care unit (ICU) admissions from the general wards between December 2015 and February 2017. This study included patients with emergency medical intubations in the general ward who were then transferred to the ICU. Vital signs measured within 24 hours prior to ICU admission were compared between patients who did and did not require emergency tracheal intubation in the general ward. A survey was also conducted to explore the nurses' attitudes toward vital sign measurements. RESULTS: Compared with other vital signs, the respiratory rate was significantly less frequently measured. Moreover, the frequency of respiratory rate measurement was lower in the 38 patients who were intubated than in the 102 patients who were not intubated in the general ward (P=0.07). The survey revealed that 54% of the participating nurses considered assessment of the respiratory rate as the most troublesome nursing task and ~15% of nurses did not routinely measure respiratory rates. CONCLUSION: Respiratory rate was less frequently assessed in deteriorating patients in the general ward, possibly because it was considered a troublesome task.

Mechanical Ventilation-Related Safety Incidents in General Care Wards and ICU Settings.

BACKGROUND: Although the ICU is the most appropriate place to care for mechanically ventilated patients, a considerable number are ventilated in general medical care wards all over the world. However, adverse events focusing on mechanically ventilated patients in general care have not been explored. METHODS: Data from the Japan Council for Quality Health Care database were analyzed. Patient safety incidents from January 2010 to November 2017 regarding mechanical ventilation were collected, and comparisons of patient safety incidents between ICUs/high care units (HCUs) and general care wards were made. RESULTS: We identified 261 adverse events (with at least 20 adverse events resulting in death) and 702 near-miss events related to mechanical ventilation in Japan between 2010 and 2017. Furthermore, among all adverse events, 19% (49 of 261 events) caused serious harm (residual disability or death). Human-factor issues were most frequent in both ICU/HCU and general care settings (55% and 53%, respectively), while knowledge-based errors were higher in the general care setting. CONCLUSIONS: Human-factor issues were the most frequent reasons in both settings, while knowledge-based error rates were higher in general care. Our results suggest that proper education and training is needed to minimize patient safety incidents in facilities without respiratory therapists.

Hematopoietic Stem Cell Transplant in Facilities Without Intensive Care Units in Japan.

OBJECTIVES: Substantial numbers of patients after hematopoietic stem cell transplant need critical care. In Japan, however, data regarding the availability of an intensive care unit and intensivists at hospitals performing hematopoietic stem cell transplant are lacking. We aimed to investigate this issue using data from the 2014 Hematopoietic Cell Transplantation in Japan Annual Report of Nationwide Survey. MATERIALS AND METHODS: We examined whether hospitals have intensive care unit facilities and whether these hospitals are authorized by the Japanese Society of Intensive Care Medicine to provide intensivist training. The number of hematopoietic cell transplantations at each hospital was collected from the Transplant Registry Unified Management Program by the Japanese Data Center for Hematopoietic Cell Transplantation. RESULTS: Among 236 hospitals that perform hematopoietic stem cell transplants, 106 hospitals did not have intensive care units certified by the Japanese Society of Intensive Care Medicine. In patients who receive hematopoietic stem cell transplants with the highest mortality rate, 947 allogeneic transplants were performed at hospitals without this certification and 73 were performed at hospitals without intensive care units. CONCLUSIONS: We found that a considerable number of hematopoietic stem cell transplants are performed at hospitals with insufficient availability of critical care facilities or physicians.

Interruption of enteral nutrition in the intensive care unit: a single-center survey.

BACKGROUND: Interruption of enteral nutrition (EN) in the intensive care unit (ICU) occurs frequently for various reasons including feeding intolerance and the conduct of diagnostic and therapeutic procedures. However, few studies have investigated the details of EN interruption practices including reasons for and duration of interruptions. There is no standard protocol to minimize EN interruptions. METHODS: This is a retrospective review of 100 patients in the ICU staying more than 72 h and receiving EN in a 12-bed, medical/surgical ICU in a tertiary care center in 2013. Data collected include total time designated for EN; the number of EN interruption episodes; reason for each interruption categorized as diagnostic study, therapeutic intervention, or gastrointestinal (GI) event, and their individual subcategories; duration of each interruption; and the presence of written orders for interruptions. RESULTS: One hundred patients staying in the ICU for at least 72 h and receiving EN were included. There were 567 episodes of EN interruption over a median ICU length of stay of 17.1 (interquartile range 8.0-22.0) days. There were a median of three EN interruption episodes per patient. EN interruption was performed for undetermined reasons (166 episodes, 29%), airway manipulation (103 episodes, 18%), GI events (78 episodes, 14%), and intermittent dialysis (71 episodes, 13%). Median duration of EN interruption in all patients was 5.5 (3.0-10.0) h. The cumulative interruption time corresponds to 19% of the total time designated for EN. Duration of EN interruption varied according to reason, including airway manipulation (9.0 [5.0-21.0] h), tracheostomy (9.5 [7.5-14.0] h), and GI events (6.5 [3.0-14.0] h). The average calorie deficits due to interruptions were 11.5% of daily target calories. Only 60 episodes (12%) had clear written orders for interruption. CONCLUSIONS: Based on this single-center retrospective chart review, interruption of EN in the ICU is frequent, reasons for and duration of interruption varied, and airway procedures are associated with a relatively longer duration of interruption. Documentation and orders were frequently missing. These results warrant development of a protocol for EN interruption.