High versus low positive end-expiratory pressure setting in patients receiving veno-venous extracorporeal membrane oxygenation support for severe acute respiratory distress syndrome: study protocol for the multicentre, randomised ExPress SAVER Trial.

INTRODUCTION: While limiting the tidal volume to 6 mL/kg during veno-venous extracorporeal membrane oxygenation (V-V ECMO) to ameliorate lung injury in patients with acute respiratory distress syndrome (ARDS) is widely accepted, the best setting for positive end-expiratory pressure (PEEP) is still controversial. This study is being conducted to investigate whether a higher PEEP setting (15 cmH2O) during V-V ECMO can decrease the duration of ECMO support needed in patients with severe ARDS, as compared with a lower PEEP setting. METHODS AND ANALYSIS: The study is an investigator-initiated, multicentre, open-label, two-arm, randomised controlled trial conducted with the participation of 20 intensive care units (ICUs) at academic as well as non-academic hospitals in Japan. The subjects of the study are patients with severe ARDS who require V-V ECMO support. Eligible patients will be randomised equally to the high PEEP group or low PEEP group. Recruitment to the study will continue until a total of 210 patients with ARDS requiring V-V ECMO support have been randomised. In the high PEEP group, PEEP will be set at 15 cmH2O from the start of V-V ECMO until the trials for liberation from V-V ECMO (or until day 28 after the allocation), while in the low PEEP group, the PEEP will be set at 5 cmH2O. Other treatments will be the same in the two groups. The primary endpoint of the study is the number of ECMO-free days until day 28, defined as the length of time (in days) from successful libration from V-V ECMO to day 28. The secondary endpoints are mortality on day 28, in-hospital mortality on day 60, ventilator-free days during the first 60 days and length of ICU stay. ETHICS AND DISSEMINATION: Ethics approval for the trial at all the participating hospitals was obtained on 27 September 2022, by central ethics approval (IRB at Hiroshima University Hospital, C2022-0006). The results of this study will be presented at domestic and international medical congresses, and also published in scientific journals. TRIAL REGISTRATION NUMBER: The Japan Registry of Clinical Trials jRCT1062220062. Registered on 28 September 2022. PROTOCOL VERSION: 28 March 2023, version 4.0.

Effect of tranexamic acid administration on intraoperative blood loss during peritonectomy: a single-center retrospective observational study.

BACKGROUND: The efficacy of tranexamic acid in elective major invasive abdominal surgeries has not yet been established. We investigated the effect of tranexamic acid administration on intraoperative blood loss during peritoneal resection of pseudomucinoma and cancerous peritoneal dissemination. METHODS: Patients aged ≥ 20 years old who underwent peritoneal resection for pseudomucinoma or cancerous peritoneal dissemination at the Kishiwada Tokushukai Hospital were included in this single-center retrospective observational study. The tranexamic acid group received 1000 mg of tranexamic acid at the start of the operation, while the control group received the same intraoperative management as the tranexamic acid group, except for the tranexamic acid administration. The primary endpoint was intraoperative blood loss, and a multivariate analysis of the contributing factors was performed. RESULTS: The median volume of intraoperative blood loss was 1372 [interquartile range, 842 - 1877] mL and 907 [516 - 1537] mL in the control and tranexamic acid groups, respectively (p < 0.01). The total volume of blood transfusion during the operation was 2040 [1480 - 2380] mL and 1560 [1000 - 2120] mL in the control and tranexamic acid groups, respectively (p = 0.02). Postoperative blood test results revealed D-dimer values of 7.5 [4.1 - 10.7] µg/mL and 1.8 [1.0 - 3.3] µg/mL in the control and tranexamic acid groups, respectively (p < 0.01). Multivariate analysis showed that tranexamic acid administration was significantly associated with decreased intraoperative blood loss (p = 0.02). CONCLUSION: Tranexamic acid administration may be useful in reducing intraoperative blood loss and blood transfusion volume during highly-invasive surgeries such as peritoneal resection of pseudomucinoma and cancerous peritoneal dissemination.

Prognosis and sequelae of severe COVID-19 patients after 6 months of hospital discharge: A retrospective cohort study.

Background: We investigated the prognosis, sequelae, and related factors of severe coronavirus disease (COVID-19) patients who required invasive mechanical ventilation 6 months after discharge from the hospital. Methods: COVID-19 patients admitted to Kishiwada Tokusyukai Hospital between April 1, 2020, and May 31, 2021, and treated with an invasive mechanical ventilator were included in this study. We conducted a telephone visit 6 months after discharge to confirm survival and asked questions about sequelae. Results: The mortality rate 6 months after discharge was 7.4%. Tracheostomy (odds ratio [OR], 0.03; 95% confidence interval [CI], 0.003-0.26), high Acute Physiology and Chronic Health Evaluation II score (16.0 [interquartile range [IQR], 11.5-17.2] vs. 11.0 [IQR, 8.0-14.0]), prolonged hospital stay (17.0 [IQR, 12.7-24.5] vs. 10.0 [IQR, 8.0-13.0]), and prolonged ventilation duration (12.5 [IQR, 10.7-20.0] vs. 8.0 [IQR, 6.0-11.0]) were associated with the risk of death. Moreover, 49% of the patients had residual disability. The most common sequelae were hoarseness, respiratory distress on exertion (31% of symptomatic patients), and muscle weakness (22%). The prone positioning therapy (OR, 5.55; 95% CI, 1.35-32.97) was associated with hoarseness, and the use of muscle relaxants (OR, infinity; 95% CI, 1.14-infinity) was a risk factor for muscle weakness. Conclusion: Although the mortality rate after the acute phase of COVID-19 was not high, many patients experienced sequelae. Careful treatment should be continued after the end of acute treatment for patients with prolonged respiratory failure due to COVID-19. Muscle relaxants and prone positioning therapy may cause sequelae and should be performed carefully.