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Serious adverse events reporting in recent randomised clinical trials in intensive care medicine – A methodological study protocol 近期重症监护医学随机临床试验中的严重不良事件报告--方法学研究方案
IF 2.1 4区 医学 Q2 ANESTHESIOLOGY Pub Date : 2024-09-12 DOI: 10.1111/aas.14512
Marie Qvist Jensen, Marie Warrer Munch, Anders Granholm, Morten Hylander Møller, Marina Bahrenkova, Anders Perner
BackgroundSerious adverse events (SAEs) are common in intensive care unit (ICU) patients. Reporting of SAEs in randomised clinical trials (RCTs) varies why underreporting is likely. We aim to describe the reporting of SAEs from 2020 onwards and to illustrate the recent reporting of SAEs published in major medical journals.MethodsWe will conduct a methodological study assessing pharmacological interventions in RCTs including adult ICU patients. We will search 10 general medical and critical care journals in PubMed. We will include all RCTs published from 2020 onwards. The primary research question is how many RCTs report SAEs in the primary publication. Secondary research questions include how SAEs are reported in the primary publication either as (1) proportion of patients experiencing one or more SAE, (2) all single events occurred, or (3) both strategies combined. We will assess the association between the proportion of patients with reported SAEs and the following trial characteristics: multicentred versus single‐centre RCTs, industry‐sponsored versus academic‐sponsored, published trial protocol versus unpublished work, blinding, trials sample size, and RCTs focusing on COVID‐19 patients versus other populations.DiscussionThe outlined methodological study will provide important information on the reporting of SAEs in recent drug trials in adult ICU patients.
背景严重不良事件(SAEs)在重症监护病房(ICU)患者中很常见。随机临床试验(RCT)中对 SAE 的报告各不相同,因此很可能存在报告不足的情况。我们旨在描述自 2020 年起的 SAE 报告情况,并说明近期在主要医学期刊上发表的 SAE 报告。方法我们将开展一项方法学研究,评估 RCT 中的药物干预措施,包括成年 ICU 患者。我们将在 PubMed 上搜索 10 种普通医学和重症监护期刊。我们将纳入 2020 年以后发表的所有 RCT。主要研究问题是有多少 RCT 在主要出版物中报告了 SAE。次要研究问题包括主要出版物中如何报告 SAE(1)发生一种或多种 SAE 的患者比例;(2)发生的所有单一事件;或(3)两种策略的结合。我们将评估报告 SAE 的患者比例与以下试验特征之间的关联:多中心 RCT 与单中心 RCT、行业赞助 RCT 与学术赞助 RCT、已发表的试验方案与未发表的工作、盲法、试验样本大小、侧重于 COVID-19 患者的 RCT 与侧重于其他人群的 RCT。
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引用次数: 0
Quantity: More markers, more merit 数量:更多标记,更多优点
IF 2.1 4区 医学 Q2 ANESTHESIOLOGY Pub Date : 2024-09-12 DOI: 10.1111/aas.14521
Albert Gyllencreutz Castellheim, Elin M. Thorlacius
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引用次数: 0
Comment on: "Is epidural analgesia non-inferior to intrathecal fentanyl as initiation for neuraxial analgesia in early non-spontaneous labor?" 评论"硬膜外镇痛作为非自然分娩早期神经镇痛的起始手段,效果是否优于鞘内芬太尼?
IF 1.9 4区 医学 Q2 ANESTHESIOLOGY Pub Date : 2024-09-01 Epub Date: 2024-05-27 DOI: 10.1111/aas.14460
Raghuraman M Sethuraman
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引用次数: 0
Platelet transfusions in adult ICU patients with thrombocytopenia: A sub-study of the PLOT-ICU inception cohort study. 成人重症监护病房血小板减少症患者的血小板输注:PLOT-ICU初始队列研究的一项子研究。
IF 1.9 4区 医学 Q2 ANESTHESIOLOGY Pub Date : 2024-09-01 Epub Date: 2024-06-05 DOI: 10.1111/aas.14467
Carl Thomas Anthon, Frédéric Pène, Anders Perner, Elie Azoulay, Kathryn Puxty, Andry Van De Louw, Sanjay Chawla, Pedro Castro, Pedro Povoa, Luis Coelho, Victoria Metaxa, Matthias Kochanek, Tobias Liebregts, Thomas Kander, Mirka Sivula, Jo Bønding Andreasen, Lene Bjerregaard Nielsen, Christine Lodberg Hvas, Etienne Dufranc, Emmanuel Canet, Christopher John Wright, Julien Schmidt, Fabrice Uhel, Louai Missri, Mette Krag, Elisabet Cos Badia, Cándido Díaz-Lagares, Sophie Menat, Guillaume Voiriot, Niels Erikstrup Clausen, Kristian Lorentzen, Reidar Kvåle, Andreas Barratt-Due, Thomas Hildebrandt, Aleksander Rygh Holten, Kristian Strand, Morten Heiberg Bestle, Pål Klepstad, Damien Vimpere, Carolina Paulino, Catherina Lueck, Christian Svendsen Juhl, Carolina Costa, Per Martin Bådstøløkken, Lia Susana Aires Lêdo, Morten Hylander Møller, Lene Russell

Background: Platelet transfusions are frequently used in the intensive care unit (ICU), but current practices including used product types, volumes, doses and effects are unknown.

Study design and methods: Sub-study of the inception cohort study 'Thrombocytopenia and Platelet Transfusions in the ICU (PLOT-ICU)', including acutely admitted, adult ICU patients with thrombocytopenia (platelet count <150 × 109/L). The primary outcome was the number of patients receiving platelet transfusion in ICU by product type. Secondary outcomes included platelet transfusion details, platelet increments, bleeding, other transfusions and mortality.

Results: Amongst 504 patients with thrombocytopenia from 43 hospitals in 10 countries in Europe and the United States, 20.8% received 565 platelet transfusions; 61.0% received pooled products, 21.9% received apheresis products and 17.1% received both with a median of 2 (interquartile range 1-4) days from admission to first transfusion. The median volume per transfusion was 253 mL (180-308 mL) and pooled products accounted for 59.1% of transfusions, however, this varied across countries. Most centres (73.8%) used fixed dosing (medians ranging from 2.0 to 3.5 × 1011 platelets/transfusion) whilst some (mainly in France) used weight-based dosing (ranging from 0.5 to 0.7 × 1011 platelets per 10 kg body weight). The median platelet count increment for a single prophylactic platelet transfusion was 2 (-1 to 8) × 109/L. Outcomes of patients with thrombocytopenia who did and did not receive platelet transfusions varied.

Conclusions: Among acutely admitted, adult ICU patients with thrombocytopenia, 20.8% received platelet transfusions in ICU of whom most received pooled products, but considerable variation was observed in product type, volumes and doses across countries. Prophylactic platelet transfusions were associated with limited increases in platelet counts.

背景:重症监护病房(ICU)经常使用血小板输注,但目前的做法,包括使用的产品类型、数量、剂量和效果尚不清楚:研究设计:"重症监护室血小板减少症和血小板输注(PLOT-ICU)"初始队列研究的子研究,包括急性入院的重症监护室成人血小板减少症患者(血小板计数为 9/L)。主要结果是按产品类型分列的在重症监护室接受血小板输注的患者人数。次要结果包括血小板输注详情、血小板增量、出血、其他输血和死亡率:在来自欧洲和美国 10 个国家 43 家医院的 504 名血小板减少症患者中,20.8% 的患者接受了 565 次血小板输注;61.0% 的患者接受了集合产品,21.9% 的患者接受了无细胞产品,17.1% 的患者同时接受了两种产品。每次输血量的中位数为 253 毫升(180-308 毫升),集合产品占输血量的 59.1%,但各国的情况有所不同。大多数中心(73.8%)使用固定剂量(中位数范围为 2.0 至 3.5 × 1011 个血小板/次输血),而一些中心(主要在法国)则使用基于体重的剂量(范围为每 10 千克体重 0.5 至 0.7 × 1011 个血小板)。单次预防性血小板输注的血小板计数增量中位数为 2(-1 至 8)×109/L。接受和未接受血小板输注的血小板减少症患者的预后各不相同:结论:在急性入院的成人血小板减少症重症监护病房患者中,20.8%的患者在重症监护病房接受了血小板输注,其中大部分患者接受的是集合产品,但不同国家的产品类型、输注量和剂量存在很大差异。预防性血小板输注对血小板计数的增加作用有限。
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引用次数: 0
Nitrous oxide inhalation: History and experiences. 吸入一氧化二氮:历史与经验。
IF 1.9 4区 医学 Q2 ANESTHESIOLOGY Pub Date : 2024-09-01 Epub Date: 2024-05-30 DOI: 10.1111/aas.14462
Golo Kronenberg, Erich Seifritz, Sebastian Olbrich
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引用次数: 0
Empirical meropenem versus piperacillin/tazobactam for adult patients with sepsis (EMPRESS) trial: Protocol. 针对成人败血症患者的经验性美罗培南与哌拉西林/他唑巴坦(EMPRESS)试验:协议。
IF 1.9 4区 医学 Q2 ANESTHESIOLOGY Pub Date : 2024-09-01 Epub Date: 2024-05-20 DOI: 10.1111/aas.14441
Anders Granholm, Marie Warrer Munch, Nick Meier, Fredrik Sjövall, Marie Helleberg, Frederik Boëtius Hertz, Benjamin Skov Kaas-Hansen, Hans-Christian Thorsen-Meyer, Lars Wiuff Andersen, Bodil Steen Rasmussen, Jakob Steen Andersen, Trine Lynge Albertsen, Maj-Brit Nørregaard Kjær, Aksel Karl Georg Jensen, Theis Lange, Anders Perner, Morten Hylander Møller

Background: Piperacillin/tazobactam may be associated with less favourable outcomes than carbapenems in patients with severe bacterial infections, but the certainty of evidence is low.

Methods: The Empirical Meropenem versus Piperacillin/Tazobactam for Adult Patients with Sepsis (EMPRESS) trial is an investigator-initiated, international, parallel-group, randomised, open-label, adaptive clinical trial with an integrated feasibility phase. We will randomise adult, critically ill patients with sepsis to empirical treatment with meropenem or piperacillin/tazobactam for up to 30 days. The primary outcome is 30-day all-cause mortality. The secondary outcomes are serious adverse reactions within 30 days; isolation precautions due to resistant bacteria within 30 days; days alive without life support and days alive and out of hospital within 30 and 90 days; 90- and 180-day all-cause mortality and 180-day health-related quality of life. EMPRESS will use Bayesian statistical models with weak to somewhat sceptical neutral priors. Adaptive analyses will be conducted after follow-up of the primary outcome for the first 400 participants concludes and after every 300 subsequent participants, with adaptive stopping for superiority/inferiority and practical equivalence (absolute risk difference <2.5%-points) and response-adaptive randomisation. The expected sample sizes in scenarios with no, small or large differences are 5189, 5859 and 2570 participants, with maximum 14,000 participants and ≥99% probability of conclusiveness across all scenarios.

Conclusions: EMPRESS will compare the effects of empirical meropenem against piperacillin/tazobactam in adult, critically ill patients with sepsis. Due to the pragmatic, adaptive design with high probability of conclusiveness, the trial results are expected to directly inform clinical practice.

背景:在严重细菌感染患者中,哌拉西林/他唑巴坦的疗效可能不如碳青霉烯类:与碳青霉烯类药物相比,哌拉西林/他唑巴坦可能对严重细菌感染患者的疗效较差,但证据的确定性较低:针对成人败血症患者的经验性美罗培南与哌拉西林/他唑巴坦对比试验(EMPRESS)是一项由研究者发起的国际性、平行分组、随机、开放标签、适应性临床试验,其中包含一个综合可行性阶段。我们将随机安排成年脓毒症重症患者接受美罗培南或哌拉西林/他唑巴坦的经验性治疗,疗程长达 30 天。主要结果是 30 天的全因死亡率。次要结果是 30 天内的严重不良反应;30 天内因耐药菌而采取的隔离预防措施;30 天和 90 天内无生命支持的存活天数和出院存活天数;90 天和 180 天的全因死亡率以及 180 天的健康相关生活质量。EMPRESS 将使用贝叶斯统计模型,并采用弱到有点怀疑的中性先验。将在对前 400 名参与者的主要结果进行随访后进行适应性分析,并在随后每 300 名参与者进行随访后进行适应性分析,同时对优劣性和实际等效性(绝对风险差异结论)进行适应性停止分析:EMPRESS 将比较经验性美罗培南与哌拉西林/他唑巴坦对成人败血症重症患者的疗效。由于该试验采用务实、适应性强的设计,具有很高的结论可能性,预计试验结果将直接指导临床实践。
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引用次数: 0
Potential organ donors during two years at the second largest hospital in Norway. 在挪威第二大医院的两年时间里,潜在的器官捐献者。
IF 1.9 4区 医学 Q2 ANESTHESIOLOGY Pub Date : 2024-09-01 Epub Date: 2024-05-27 DOI: 10.1111/aas.14455
Gunhild Holmaas, Edle Hilton, Stein Foss, Gaute K Wathle, Reidar Kvåle

Background: Western Norway has the lowest number of actual deceased organ donors per million inhabitants in Norway. We wished to find the total number of potential donors and donor organs during 2 years at Haukeland University Hospital, the largest hospital in the region, and evaluate where and why potential donors were lost.

Methods: We evaluated all patients who died at Haukeland University Hospital in 2018-19. We checked if intensive care patients, filling the criteria as organ donors after brain death, became donors, and the reasons why potential donors were lost. We also estimated the number of potential donors after circulatory death. We checked if patients transferred from the intensive care units and patients never admitted to intensive care were potential donors. Location, gender, age, and possible number of organs were registered.

Results: Of 1453 in-hospital deaths, 20 brain-dead patients became actual donors. One brain-dead and two other potential donors, one of them discharged to a bed ward, were not evaluated at the intensive care units. Relatives refused in five patients. Three fulfilled the Norwegian criteria from 2021 as organ donors after circulatory death. Ten potential donors after brain death were never admitted to intensive care and died on neurological or neurosurgical wards. If all potential organ donors were realised, the number of donors would double. The number of transplanted organs would increase less, as organs used per donor would drop from 3.50 to 2.90.

Conclusion: Our study cannot explain the low number of donors in our region compared with the rest of Norway. If all potential donations were implemented, the number of actual donors would double. Patients dying outside the intensive care units represent the largest potential source for extra donors, maximally increasing the number of donors by 42%, high-quality livers 44% and kidneys 18%. Introducing organ donation after circulatory death may increase the number of donors by 15% and the number of high-quality livers and kidneys by 12%.

背景:挪威西部是挪威每百万居民中实际死亡器官捐献者最少的地区。我们希望了解该地区最大的医院--豪克兰大学医院两年内潜在捐献者和捐献器官的总人数,并评估潜在捐献者在哪里以及为什么会流失:我们对 2018-19 年在豪科兰大学医院死亡的所有患者进行了评估。我们检查了符合脑死亡后器官捐献标准的重症监护患者是否成为捐献者,以及潜在捐献者流失的原因。我们还估算了循环死亡后的潜在捐献者人数。我们检查了从重症监护室转出的患者和从未入住重症监护室的患者是否有可能捐献器官。我们登记了地点、性别、年龄和可能的器官数量:结果:在 1453 例院内死亡病例中,有 20 例脑死亡患者成为实际捐献者。有一名脑死亡患者和另外两名潜在捐献者(其中一人已出院住进病床病房)未在重症监护病房接受评估。五名患者的亲属拒绝捐献。其中三人符合挪威 2021 年关于循环死亡后器官捐献者的标准。有 10 名潜在的脑死亡器官捐献者从未入住重症监护病房,而是死于神经科或神经外科病房。如果所有潜在的器官捐献者都能实现捐献,那么捐献者的数量将增加一倍。移植器官的数量增幅较小,因为每位捐献者使用的器官将从 3.50 个降至 2.90 个:与挪威其他地区相比,我们的研究无法解释本地区器官捐献者人数偏低的原因。如果所有潜在的捐献都得以实施,实际捐献者的数量将翻一番。在重症监护室外死亡的病人是额外捐献者的最大潜在来源,最大限度地增加了42%的捐献者人数,优质肝脏捐献者增加了44%,肾脏捐献者增加了18%。在循环死亡后进行器官捐献可使捐献者人数增加 15%,高质量肝脏和肾脏的数量增加 12%。
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引用次数: 0
Blood transfusion practices in paediatric perioperative care: Insights from the TUPAC initiative. 儿科围手术期护理中的输血实践:TUPAC倡议的启示。
IF 1.9 4区 医学 Q2 ANESTHESIOLOGY Pub Date : 2024-09-01 Epub Date: 2024-05-23 DOI: 10.1111/aas.14458
Florian Piekarski, Thomas Engelhardt
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引用次数: 0
In response to "Nitrous oxide inhalation: History and experiences," a letter to the Editor by Kroneberg et al. 针对 Kroneberg 等人撰写的 "一氧化二氮吸入:Kroneberg等人写给编辑的一封信。
IF 1.9 4区 医学 Q2 ANESTHESIOLOGY Pub Date : 2024-09-01 Epub Date: 2024-06-25 DOI: 10.1111/aas.14469
Petra Valtonen, Saara Markkanen, Kaija Järventausta, Mirja Tenhunen, Maija-Liisa Kalliomäki
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引用次数: 0
A standard operating procedure for prehospital anaesthesia and its effect on mortality-An observational study. 院前麻醉标准操作程序及其对死亡率的影响--一项观察性研究。
IF 1.9 4区 医学 Q2 ANESTHESIOLOGY Pub Date : 2024-09-01 Epub Date: 2024-05-26 DOI: 10.1111/aas.14459
Harry Ljungqvist, Jussi Pirneskoski, Anssi Saviluoto, Timo Iirola, Hetti Kirves, Jouni Nurmi

Background: Prehospital anaesthesia is a complex intervention performed for critically ill patients. To minimise complications, a standard operating procedure (SOP) outlining the process is considered valuable. We investigated the implementation of an SOP for prehospital anaesthesia in helicopter emergency medical services (HEMS).

Methods: We performed a retrospective observational study of patients receiving prehospital anaesthesia by Finnish HEMS from January 2012 to August 2019. The intervention studied was the implementation of an SOP at two of the five bases during 2015-2016. Patients were stratified according to whether they were anaesthetised before, during or after implementation and the primary outcomes were 1- and 30-day mortality. Secondary outcomes included anaesthesia quality indicators. Confounding factors was assessed via logistic regression.

Results: A total of 3902 tracheal intubations were performed without an SOP, 430 during implementation and 1525 after implementation. The SOP had a significant effect on 1-day mortality during implementation with an odds ratio (OR) of 0.56, 95% confidence interval (95% CI) 0.37-0.81 and a further trend towards benefit after implementation (OR 0.84, 95% CI 0.68-1.04), but no difference in 30-day mortality (OR after implementation 1.10, 95% CI 0.92-1.30). Implementation of an SOP improved first-pass success rate from 87.3% to 96.5%, p < 0.001.

Conclusion: Implementation of an SOP for prehospital anaesthesia was associated with a trend towards lower 1-day mortality and an improved first-pass success but did not affect 30-day mortality. Despite this, we advocate prehospital systems to consider implementation of a prehospital anaesthesia SOP as immediate performance markers improved significantly.

背景:院前麻醉是为危重病人实施的一项复杂干预措施。为了最大限度地减少并发症,概述该过程的标准操作程序(SOP)被认为是非常有价值的。我们对直升机急救医疗服务(HEMS)院前麻醉标准操作程序的实施情况进行了调查:我们对 2012 年 1 月至 2019 年 8 月期间接受芬兰直升机急救服务院前麻醉的患者进行了回顾性观察研究。研究的干预措施是在 2015-2016 年期间在五个基地中的两个基地实施 SOP。根据实施前、实施期间或实施后的麻醉情况对患者进行分层,主要结果为1天和30天死亡率。次要结果包括麻醉质量指标。混杂因素通过逻辑回归进行评估:结果:共有 3902 例气管插管在没有 SOP 的情况下进行,430 例在实施期间进行,1525 例在实施后进行。在实施过程中,SOP 对 1 天死亡率有明显影响,几率比 (OR) 为 0.56,95% 置信区间 (95% CI) 为 0.37-0.81,实施后有进一步获益的趋势(OR 为 0.84,95% CI 为 0.68-1.04),但对 30 天死亡率没有影响(实施后 OR 为 1.10,95% CI 为 0.92-1.30)。实施 SOP 后,急救成功率从 87.3% 提高到 96.5%(P 结论:实施 SOP 后,急救成功率从 87.3% 提高到 96.5%:实施院前麻醉 SOP 有降低 1 天死亡率和提高首次麻醉成功率的趋势,但不会影响 30 天死亡率。尽管如此,我们仍建议院前系统考虑实施院前麻醉 SOP,因为即时绩效指标已得到显著改善。
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引用次数: 0
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Acta Anaesthesiologica Scandinavica
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