AimTo evaluate whether a phased multidimensional intervention bundle would decrease the mortality of patients with extracorporeal membrane oxygenation (ECMO) and the complication incidence.Materials and methodsWe conducted a prospective observational study in comparison with a retrospective control group in six intensive care units (ICUs) in China. Patients older than 18 years supported with ECMO between March 2018 to March 2022 were included in the study. A phased intervention bundle to improve the outcome of patients with ECMO was developed and implemented. Multivariable logistic regression modeling was used to compare the mortality of patients with ECMO and the complication incidence before, during, and up to 18 months after implementation of the intervention bundle.ResultsThe cohort included 297 patients in 6 ICUs, mostly VA ECMO (68.7%) with a median (25th–75th percentile) duration in ECMO of 9.0 (4.0–15.0) days. The mean (SD) APECHII score was 24.1 (7.5). Overall, the mortality of ECMO decreased from 57.1% at baseline to 21.8% at 13–18 months after implementation of the study intervention (P < 0.001). In multivariable analysis, even after excluding the confounding factors, such as age, APECHII score, pre-ECMO lactate, and incidence of CRRT during ECMO, the intervention bundle still can decrease the mortality independently, which also remained true in the statistical analysis of V-V and V-A ECMO separately. Among all the ECMO-related complications, the incidence of bloodstream infection and bleeding decreased significantly at 13–18 months after implementation compared with the baseline. The CUSUM analysis revealed a typical learning curve with a point of inflection during the implementation of the bundle.ConclusionA phased multidimensional intervention bundle resulted in a large and sustained reduction in the mortality of ECMO that was maintained throughout the 18-month study period.Clinical trial registration[ClinicalTrials.gov], identifier [NCT05024786].
Background. Although pembrolizumab is recommended as a first-line treatment for advanced recurrent/unresectable/metastatic (R/U/M) head and neck squamous carcinoma, the differences in its efficacy among different populations need to be investigated. Methods. We reviewed 15 consecutive patients with R/U/M oral squamous cell carcinoma (OSCC) treated with pembrolizumab monotherapy at the Affiliated Hospital of Qingdao University between February 2021 and May 2022. All the 15 patients had known programmed death-ligand 1 expression and received multiple cycles of pembrolizumab monotherapy as first-line treatment. We evaluated and analyzed patients’ basic characteristics, time to first remission, the clinical efficacy of pembrolizumab monotherapy, and treatment-related adverse reactions. Results. The objective response rate of the 15 patients was 60%. Six patients (40.0%) achieved partial response, while three patients (20.0%) achieved complete response. In our study, the objective response status of the patients was observed in two to five cycles (mean, 3.6 cycles). For patients who responded well to immunotherapy, the mean Karnofsky Performance Status (KPS) score after treatment was significantly higher than that before treatment ( P < 0.001 ). The progression-free survival rates were 66.9% and 50.1% at 6 months and 1 year, respectively. Eight adverse events were observed, comprising four cases of rash and one case each of hypothyroidism, interstitial pneumonia, cheilitis, and cerebral thrombosis. Conclusion. Our study suggests that pembrolizumab is beneficial to the most responsive patients with R/U/M OSCC in our single-center study and may shed light on the management of OSCC.
Background Unfractionated heparin is used to prevent coagulation activation in patients undergoing extracorporeal membrane oxygenation (ECMO) support. We designed this study to determine the preferable indicator for anticoagulation monitoring. Methods We conducted a retrospective study and divided the patients into an activated coagulation time (ACT)-target group and an activated partial thromboplastin time (aPTT)-target group. The correlations between ACT, aPTT, and the heparin dose were explored. Results Thirty-six patients were included (19 aPTT-target and 17 ACT-target patients); a total of 555 matched pairs of ACT/aPTT results were obtained. The correlation between the ACT and aPTT measurements was Spearman's Rank Correlation Coefficient (rs) = 0.518 in all 555 pairs. The Bland–Altman plot showed data points outside the displayed range (51.2–127.7), suggesting that the agreement between ACT and aPTT was poor. The aPTT group had fewer heparin dose changes (2.12 ± 0.68 vs. 2.57 ± 0.64, p = 0.05) and a lower cumulative heparin dose (317.6 ± 108.5 vs. 396.3 ± 144.3, p = 0.00) per day than the ACT group. There was no difference in serious bleeding (9 vs. 5; p = 0.171) or embolism events (3 vs. 3; p = 1.0) or in the red blood cell and fresh frozen plasma transfusion volumes between the ACT- and aPTT-target groups. Similarly, there was no significant difference in the ECMO duration (9 [4–15] days vs. 4 [3–14] days; p = 0.124) or length of ICU hospitalization (17 [5–32] days vs. 13 [4–21] days; p = 0.451) between the groups. Conclusion The correlation between ACT and aPTT and the heparin dose was poor. The aPTT group had fewer daily heparin dose changes and a lower cumulative heparin dose per day than the ACT group, with no more bleeding and thrombotic events. Therefore, we recommend aPTT rather than ACT to adjust heparin dose in the absence of better monitoring indicators.
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