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International Delirium Pathophysiology & Electrophysiology Network for Data sharing (iDEPEND) 国际谵妄病理生理学和电生理学数据共享网络 (iDEPEND)
Pub Date : 2024-07-30 DOI: 10.1016/j.bjao.2024.100304
Robert D. Sanders , Leiv Watne , Shawniqua Williams Roberson , Eyal Y. Kimchi , Arjen J.C. Slooter , Colm Cunningham , Kirill V. Nourski , Ben J.A. Palanca , Richard Lennertz , Matthew I. Banks

In an era of ‘big data’, we propose that a collaborative network approach will drive a better understanding of the mechanisms of delirium, and more rapid development of therapies. We have formed the International Delirium Pathophysiology & Electrophysiology Network for Data sharing (iDEPEND) group with a key aim to ‘facilitate the study of delirium pathogenesis with electrophysiology, imaging, and biomarkers including data acquisition, analysis, and interpretation’. Our initial focus is on studies of electrophysiology as we anticipate this methodology has great potential to enhance our understanding of delirium. Our article describes this principle and is used to highlight the endeavour to the wider community as we establish key stakeholders and partnerships.

在 "大数据 "时代,我们建议采用合作网络的方法来更好地了解谵妄的发病机制,并更快地开发出治疗方法。我们成立了国际谵妄病理生理学与amp; 数据共享电生理学网络(iDEPEND)小组,其主要目的是 "通过电生理学、影像学和生物标记物(包括数据采集、分析和解读)促进谵妄发病机制的研究"。我们最初的重点是电生理学研究,因为我们预计这种方法在增进我们对谵妄的了解方面具有巨大潜力。我们的文章描述了这一原则,并在我们建立主要利益相关者和合作伙伴关系的过程中向更广泛的社区强调了这一努力。
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引用次数: 0
Postoperative intravenous iron to treat iron-deficiency anaemia in patients undergoing cardiac surgery: a protocol for a pilot, multicentre, placebo-controlled randomized trial (the POAM trial) 治疗心脏手术患者缺铁性贫血的术后静脉注射铁剂:多中心安慰剂对照随机试验(POAM 试验)方案
Pub Date : 2024-07-27 DOI: 10.1016/j.bjao.2024.100303
Justyna Bartoszko , Sarah Miles , Saba Ansari , Deep Grewal , Michelle Li , Jeannie Callum , Stuart A. McCluskey , Yulia Lin , Keyvan Karkouti

Background

Iron-deficiency anaemia, occurring in 30–40% of patients undergoing cardiac surgery, is an independent risk factor for adverse outcomes. Our long-term goal is to assess if postoperative i.v. iron therapy improves clinical outcomes in patients with preoperative iron-deficiency anaemia undergoing cardiac surgery. Before conducting a definitive RCT, we first propose a multicentre pilot trial to establish the feasibility of the definitive trial.

Methods

This internal pilot, double-blinded, RCT will include three centres. Sixty adults with preoperative iron-deficiency anaemia undergoing non-emergency cardiac surgery will be randomised on postoperative day 2 or 3 to receive either blinded i.v. iron (1000 mg ferric derisomaltose) or placebo. Six weeks after surgery, patients who remain iron deficient will receive a second blinded dose of i.v. iron according to their assigned treatment arm. Patients will be followed for 12 months. Clinical practice will not be otherwise modified. For the pilot study, feasibility will be assessed through rates of enrolment, protocol deviations, and loss to follow up. For the definitive study, the primary outcome will be the number of days alive and out of hospital at 90 days after surgery.

Ethics and dissemination

The trial has been approved by the University Health Network Research Ethics Board (REB # 22-5685; approved by Clinical Trials Ontario funding on 22 December 2023) and will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practices guidelines, and regulatory requirements.

Clinical trial registration

NCT06287619.

背景缺铁性贫血发生在30-40%的心脏手术患者中,是导致不良预后的一个独立风险因素。我们的长期目标是评估术后静脉注射铁剂是否能改善心脏手术术前缺铁性贫血患者的临床预后。在进行最终的 RCT 之前,我们首先建议进行一项多中心试点试验,以确定最终试验的可行性。60 名接受非急诊心脏手术的术前缺铁性贫血成人将在术后第 2 天或第 3 天随机接受盲法静脉注射铁剂(1000 毫克脱异麦芽糖铁)或安慰剂。术后六周,仍然缺铁的患者将根据指定的治疗方案接受第二次盲注铁剂。患者将接受 12 个月的随访。临床实践不会有其他改变。在试点研究中,将通过入选率、方案偏离率和随访损失率来评估可行性。伦理和传播该试验已获得大学健康网络研究伦理委员会的批准(REB # 22-5685;2023 年 12 月 22 日获得安大略省临床试验基金的批准),并将按照《赫尔辛基宣言》、《良好临床实践指南》和监管要求进行。
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引用次数: 0
Operating table stability and patient safety during an earthquake based on the results of a shaking table experiment 基于振动台实验结果的手术台稳定性和地震中的病人安全
Pub Date : 2024-07-15 DOI: 10.1016/j.bjao.2024.100301
Takahiko Tsutsumi , Keita Fukuyama , Kazumasa Kishimoto , Yukiko Mori , Osamu Sugiyama , Goshiro Yamamoto , Masahiro Kurata , Ueshima Hiroaki , Kenichi Saito , Tomohiro Kuroda , Shigeru Ohtsuru

Background

The damage that may be caused to the operating table and patients under general anaesthesia when a large earthquake occurs is unclear. We aimed to evaluate the movement and damage to operating tables and patients under general anaesthesia during an earthquake.

Methods

An operating table with a manikin resembling a patient on it was placed on a shaking table, and seismic waves were input into the shaking table. The effects of seismic waves were evaluated by altering surgical positions (supine and head-down positions), operating tables, flooring material, seismic waves, and output. We observed the movement of the operating table and measured the acceleration of the operating table and manikin head.

Results

Under 90% output of long-period seismic waves, the operating table with the supine manikin was overturned. Under experimental conditions that did not cause rocking, shaking such as tilting of the operating table caused stronger acceleration in the manikin's head than in the operating table. There was no clear relationship between operating table rocking and maximum acceleration as a result of programmed seismic waves. In long-period earthquakes, rocking and overturning occurred >60 s after the onset of shaking, whereas in direct earthquakes, rocking occurred within 10 s.

Conclusions

An earthquake could cause strong acceleration of the patient's head under general anaesthesia, and operating tables may overturn or shake violently. Regarding patient safety, further measures to prevent overturning should be considered.

背景大地震发生时可能对手术台和全身麻醉患者造成的损害尚不清楚。我们的目的是评估地震时手术台和全身麻醉患者的移动和损坏情况。方法将一个手术台和一个类似患者的人体模型放在振动台上,并向振动台输入地震波。通过改变手术体位(仰卧位和头低位)、手术台、地板材料、地震波和输出量来评估地震波的影响。我们观察了手术台的移动,并测量了手术台和人体模型头部的加速度。结果在 90% 的长周期地震波输出条件下,带有仰卧人体模型的手术台被掀翻。在不引起摇晃的实验条件下,手术台倾斜等晃动对人体模型头部造成的加速度比对手术台造成的加速度更大。手术台摇晃与程序地震波产生的最大加速度之间没有明显的关系。在长周期地震中,摇晃和翻转发生在摇晃开始后 60 秒内,而在直接地震中,摇晃发生在 10 秒内。关于病人安全,应考虑采取进一步措施防止翻转。
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引用次数: 0
Personalised blood pressure management during major noncardiac surgery and postoperative neurocognitive disorders: a randomised trial 非心脏大手术期间的个性化血压管理与术后神经认知障碍:随机试验
Pub Date : 2024-07-01 DOI: 10.1016/j.bjao.2024.100294
Julia Y. Nicklas , Alina Bergholz , Francesco Däke , Hanh H.D. Pham , Marie-Christin Rabe , Hanna Schlichting , Sophia Skrovanek , Moritz Flick , Karim Kouz , Marlene Fischer , Cynthia Olotu , Jakob R. Izbicki , Oliver Mann , Margit Fisch , Barbara Schmalfeldt , Karl-Heinz Frosch , Thomas Renné , Linda Krause , Christian Zöllner , Bernd Saugel

Background

It remains unknown whether there is a causal relationship between intraoperative hypotension and postoperative neurocognitive disorders. We tested the hypothesis that personalised—compared to routine—intraoperative blood pressure management reduces the incidence of postoperative neurocognitive disorders in patients having major noncardiac surgery.

Methods

In this single-centre trial, 328 elective major noncardiac surgery patients were randomly allocated to receive personalised blood pressure management (i.e. maintaining intraoperative mean arterial pressure [MAP] above preoperative baseline MAP from automated 24-h blood pressure monitoring) or routine blood pressure management (i.e. maintaining MAP above 65 mm Hg). The primary outcome was the incidence of neurocognitive disorders (composite of delayed neurocognitive recovery and delirium) between postoperative days 3 and 7.

Results

The primary outcome, neurocognitive disorders, occurred in 18 of 147 patients (12%) assigned to personalised and 21 of 148 patients (14%) assigned to routine blood pressure management (odds ratio [OR]=0.84, 95% confidence interval [CI]: 0.40–1.75, P=0.622). Delayed neurocognitive recovery occurred in 17 of 146 patients (12%) assigned to personalised and 17 of 145 patients (12%) assigned to routine blood pressure management (OR=0.99, 95% CI: 0.45–2.17, P=0.983). Delirium occurred in 2 of 157 patients (1%) assigned to personalised and 4 of 158 patients (3%) assigned to routine blood pressure management (OR=0.50, 95% CI: 0.04–3.53, P=0.684).

Conclusions

Personalised intraoperative blood pressure management maintaining preoperative baseline MAP neither reduced the incidence of the composite primary outcome neurocognitive disorders between postoperative days 3 and 7 nor the incidences of the components of the composite primary outcome—delayed neurocognitive recovery and delirium—compared to routine blood pressure management in patients having major noncardiac surgery.

Clinical trial registration

ClinicalTrials.gov (NCT03442907).

背景目前仍不清楚术中低血压与术后神经认知障碍之间是否存在因果关系。在这项单中心试验中,328 名择期接受重大非心脏手术的患者被随机分配接受个性化血压管理(即术中平均动脉压 [MAP] 保持在 24 小时自动血压监测的术前基线 MAP 以上)或常规血压管理(即 MAP 保持在 65 mm Hg 以上)。主要结果是术后第 3 天和第 7 天之间神经认知障碍(神经认知延迟恢复和谵妄的复合结果)的发生率。结果147 名患者中有 18 名(12%)被分配到个性化血压管理方案,148 名患者中有 21 名(14%)被分配到常规血压管理方案(几率比 [OR]= 0.84,95% 置信区间 [CI]:0.40-1.75,P=0.622)。在 146 名被分配到个性化血压管理的患者中,有 17 人(12%)出现神经认知功能延迟恢复;在 145 名被分配到常规血压管理的患者中,有 17 人(12%)出现神经认知功能延迟恢复(OR=0.99,95% 置信区间[CI]:0.45-2.17,P=0.983)。在157名接受个性化血压管理的患者中,有2人(1%)出现谵妄;在158名接受常规血压管理的患者中,有4人(3%)出现谵妄(OR=0.50,95% CI:0.04-3.53,P=0.684)。结论与常规血压管理相比,个性化术中血压管理维持术前基线MAP既不会降低非心脏大手术患者术后第3天和第7天的综合主要结果神经认知障碍的发生率,也不会降低综合主要结果的组成部分--神经认知恢复延迟和谵妄的发生率。
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引用次数: 0
Changes of pulse wave transit time after haemodynamic manoeuvres in healthy adults: a prospective randomised observational trial (PWTT volunteer study) 健康成年人进行血液动力学操作后脉搏波转运时间的变化:前瞻性随机观察试验(PWTT 志愿者研究)
Pub Date : 2024-06-24 DOI: 10.1016/j.bjao.2024.100291
Johannes M. Wirkus , Fabienne Goss , Matthias David , Erik K. Hartmann , Kimiko Fukui , Irene Schmidtmann , Eva Wittenmeier , Gunther J. Pestel , Eva-Verena Griemert

Background

Pulse wave transit time (PWTT) shows promise for monitoring intravascular fluid status intraoperatively. Presently, it is unknown how PWTT mirrors haemodynamic variables representing preload, inotropy, or afterload.

Methods

PWTT was measured continuously in 24 adult volunteers. Stroke volume was assessed by transthoracic echocardiography. Volunteers underwent four randomly assigned manoeuvres: ‘Stand-up’ (decrease in preload), passive leg raise (increase in preload), a ‘step-test’ (adrenergic stimulation), and a ‘Valsalva manoeuvre’ (increase in intrathoracic pressure). Haemodynamic measurements were performed before and 1 and 5 min after completion of each manoeuvre. Correlations between PWTT and stroke volume were analysed using the Pearson correlation coefficient.

Results

‘Stand-up’ caused an immediate increase in PWTT (mean change +55.9 ms, P-value <0.0001, 95% confidence interval 46.0–65.7) along with an increase in mean arterial pressure and heart rate and a drop in stroke volume (P-values <0.0001). Passive leg raise caused an immediate drop in PWTT (mean change −15.4 ms, P-value=0.0024, 95% confidence interval −25.2 to −5.5) along with a decrease in mean arterial pressure (P-value=0.0052) and an increase in stroke volume (P-value=0.001). After 1 min, a ‘step-test’ caused no significant change in PWTT measurements (P-value=0.5716) but an increase in mean arterial pressure and heart rate (P-values <0.0001), without changes in stroke volume (P-value=0.1770). After 5 min, however, PWTT had increased significantly (P-value <0.0001). Measurements after the Valsalva manoeuvre caused heterogeneous results.

Conclusion

Noninvasive assessment of PWTT shows promise to register immediate preload changes in healthy adults. The clinical usefulness of PWTT may be hampered by late changes because of reasons different from fluid shifts.

Clinical trial registration

German clinical trial register (DRKS, ID: DRKS00031978, https://www.drks.de/DRKS00031978).

背景脉搏波转运时间(PWTT)有望用于术中监测血管内液体状态。目前,还不清楚 PWTT 如何反映代表前负荷、肌力或后负荷的血流动力学变量。通过经胸超声心动图评估卒中容量。志愿者接受了四种随机分配的动作:"起立"(减少前负荷)、被动抬腿(增加前负荷)、"台阶试验"(肾上腺素能刺激)和 "瓦尔萨尔瓦动作"(增加胸内压)。在每个动作之前、完成后 1 分钟和 5 分钟进行血流动力学测量。结果 "起立 "导致脉搏波速度立即增加(平均变化+55.9毫秒,P值为0.0001,95%置信区间为46.0-65.7),同时平均动脉压和心率增加,搏出量下降(P值为0.0001)。被动抬腿导致 PWTT 立即下降(平均变化-15.4 毫秒,P 值=0.0024,95% 置信区间-25.2 至-5.5),同时平均动脉压下降(P 值=0.0052),搏出量增加(P 值=0.001)。1 分钟后,"台阶试验 "导致脉搏波速度测量值无明显变化(P-value=0.5716),但平均动脉压和心率增加(P-value <0.0001),而每搏容量无变化(P-value=0.1770)。然而,5 分钟后,脉搏波速度明显增加(P 值为 0.0001)。结论无创脉搏波速度评估有望记录健康成年人的即时前负荷变化。临床试验注册德国临床试验注册(DRKS,ID:DRKS00031978,https://www.drks.de/DRKS00031978)。
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引用次数: 0
Effects of opioid-based versus opioid-free anaesthesia on blinded nociception level index values during laparoscopic gastric bypass surgery: a secondary analysis of a randomised double-blind trial 腹腔镜胃旁路手术期间,基于阿片类药物的麻醉与不含阿片类药物的麻醉对盲目痛觉水平指数值的影响:随机双盲试验的二次分析
Pub Date : 2024-06-20 DOI: 10.1016/j.bjao.2024.100295
Sean Coeckelenbergh , Teodora Oltean , Anne-Catherine Dandrifosse , Matthieu Clanet , Alexandre Joosten
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引用次数: 0
Efficacy of parasternal peripheral nerve catheters versus no block for median sternotomy: a single-centre retrospective study 胸骨正中切开术中胸骨旁周围神经导管与无阻滞的疗效对比:一项单中心回顾性研究
Pub Date : 2024-06-20 DOI: 10.1016/j.bjao.2024.100288
John E. Rubin , Vanessa Ng , Justin Chung , Nicolas Salvatierra , Brady Rippon , Diana Khatib , Natalia I. Girardi , Kane O. Pryor , Roniel Y. Weinberg , Silis Jiang , Sherif Khairallah , Stephanie L. Mick , Tiffany R. Tedore

Background

Sternal pain after cardiac surgery results in considerable discomfort. Single-injection parasternal fascial plane blocks have been shown to reduce pain scores and opioid consumption during the first 24 h after surgery, but the efficacy of continuous infusion has not been evaluated. This retrospective cohort study examined the effect of a continuous infusion of local anaesthetic through parasternal catheters on the integrated Pain Intensity and Opioid Consumption (PIOC) score up to 72 h.

Methods

We performed a retrospective analysis of patients undergoing cardiac surgery with median sternotomy at a single academic centre before and after the addition of parasternal nerve catheters to a standard multimodal analgesic protocol. Outcomes included PIOC score, total opioid consumption in oral morphine equivalents, and time-weighted area under the curve pain scores up to 72 h after surgery.

Results

Continuous infusion of ropivacaine 0.1% through parasternal catheters resulted in a significant reduction in PIOC scores at 24 h (−62, 95% confidence interval −108 to −16; P<0.01) and 48 h (−50, 95% CI −97 to −2.2; P=0.04) compared with no block. A significant reduction in opioid consumption up to 72 h was the primary factor in reduction of PIOC.

Conclusions

This study suggests that continuous infusion of local anaesthetic through parasternal catheters may be a useful addition to a multimodal analgesic protocol in patients undergoing cardiac surgery with sternotomy. Further prospective study is warranted to determine the full benefits of continuous infusion compared with single injection or no block.

背景心脏手术后的胸骨疼痛会导致严重不适。有研究表明,单次注射胸骨旁筋膜面阻滞可降低术后 24 小时内的疼痛评分和阿片类药物消耗量,但连续输注的疗效尚未得到评估。这项回顾性队列研究探讨了通过胸骨旁导管持续输注局麻药对72小时内疼痛强度和阿片类药物消耗量(PIOC)综合评分的影响。方法我们对一家学术中心接受胸骨正中切开术的心脏手术患者在标准多模式镇痛方案中添加胸骨旁神经导管前后的情况进行了回顾性分析。结果与无阻滞相比,通过胸骨旁导管持续输注0.1%罗哌卡因可显著降低24小时(-62,95%置信区间-108至-16;P<0.01)和48小时(-50,95%置信区间-97至-2.2;P=0.04)的PIOC评分。结论这项研究表明,通过胸骨旁导管持续输注局麻药可能是胸骨切开术心脏手术患者多模式镇痛方案的有益补充。需要进一步开展前瞻性研究,以确定持续输注与单次注射或无阻滞相比的全部益处。
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引用次数: 0
Area under the curve and amplitude of the compound motor action potential are clinically interchangeable quantitative measures of neuromuscular block: a method comparison study 曲线下面积和复合运动动作电位振幅是临床上可互换的神经肌肉阻滞定量测量方法:方法比较研究
Pub Date : 2024-06-13 DOI: 10.1016/j.bjao.2024.100293
Richard H. Epstein , Réka Nemes , Johnathan R. Renew , Sorin J. Brull

Background

Current guidelines recommend quantitative neuromuscular block monitoring during neuromuscular blocking agent administration. Monitors using surface electromyography (EMG) determine compound motor action potential (cMAP) amplitude or area under the curve (AUC). Rigorous evaluation of the interchangeability of these methods is lacking but necessary for clinical and research assurance that EMG interpretations of the depth of neuromuscular block are not affected by the methodology.

Methods

Digitised EMG waveforms were studied from 48 patients given rocuronium during two published studies. The EMG amplitudes and AUCs were calculated pairwise from all cMAPs classified as valid by visual inspection. Ratios of the first twitch (T1) to the control T1 before administration of rocuronium (T1c) and train-of-four ratios (TOFRs) were compared using repeated measures Bland–Altman analysis.

Results

Among the 2419 paired T1/T1c differences where the average T1/T1c was ≤0.2, eight (0.33%) were outside prespecified clinical limits of agreement (−0.148 to 0.164). Among the 1781 paired TOFR differences where the average TOFR was ≥0.8, 70 (3.93%) were outside the prespecified clinical limits of agreement ((−0.109 to 0.134). Among all 7286 T1/T1c paired differences, the mean bias was 0.32 (95% confidence interval 0.202–0.043), and among all 5559 paired TOFR differences, the mean bias was 0.011 (95% confidence interval 0.0050–0.017). Among paired T1/T1c and TOFR differences, Lin's concordance correlation coefficients were 0.98 and 0.995, respectively. Repeatability coefficients for T1/T1c and TOFR were <0.08, with no differences between methods.

Conclusions

Quantitative assessment neuromuscular block depth is clinically interchangeable when calculated using cMAP amplitude or the AUC.

背景目前的指南建议在使用神经肌肉阻滞剂期间进行定量神经肌肉阻滞监测。使用表面肌电图(EMG)监测仪可确定复合运动动作电位(cMAP)振幅或曲线下面积(AUC)。目前还没有对这些方法的互换性进行严格评估,但有必要对这些方法进行临床和研究评估,以确保 EMG 对神经肌肉阻滞深度的解释不受方法的影响。EMG振幅和AUC是通过目视检查归类为有效的所有cMAP成对计算得出的。结果在平均 T1/T1c ≤0.2 的 2419 个配对 T1/T1c 差异中,有 8 个(0.33%)超出了预先规定的临床一致性范围(-0.148 至 0.164)。在平均 TOFR ≥0.8 的 1781 个配对 TOFR 差异中,有 70 个(3.93%)不在预设的临床一致性范围内(-0.109 至 0.134)。在所有 7286 个 T1/T1c 配对差异中,平均偏差为 0.32(95% 置信区间为 0.202-0.043),在所有 5559 个 TOFR 配对差异中,平均偏差为 0.011(95% 置信区间为 0.0050-0.017)。在配对的 T1/T1c 和 TOFR 差异中,林氏一致性相关系数分别为 0.98 和 0.995。结论使用 cMAP 振幅或 AUC 计算神经肌肉阻滞深度的定量评估在临床上是可以互换的。
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引用次数: 0
Fabrication and assessment of a bio-inspired synthetic tracheal tissue model for tracheal tube cuff leakage testing 制作和评估用于气管导管袖带泄漏测试的生物启发合成气管组织模型
Pub Date : 2024-06-01 DOI: 10.1016/j.bjao.2024.100290
Tamaralayefa Agbiki , Richard Arm , David W. Hewson , Sandor Erdody , Andrew M. Norris , Ricardo Correia , Sergiy Korposh , Barrie R. Hayes-Gill , Arash Shahidi , Stephen P. Morgan

Introduction

Leakage of orogastric secretions past the cuff of a tracheal tube is a contributory factor in ventilator-associated pneumonia. Current bench test methods specified in the International Standard for Anaesthetic and Respiratory Equipment (EN ISO 5361:2023) to test cuff leakage involve using a glass or plastic rigid cylinder model of the trachea. There is a need for more realistic models to inform cuff leakage.

Methods

We used human computerised tomography data and additive manufacturing (3D printing), combined with casting techniques to fabricate a bio-inspired synthetic tracheal model with analogous tissue characteristics. We conducted cuff leakage tests according to EN ISO 5361:2023 and compared results for high-volume low-pressure polyvinyl chloride and polyurethane cuffs between the rigid cylinder trachea with our bio-inspired model.

Results

The tracheal model demonstrated close agreement with published tracheal tissue hardness for cartilaginous and membranous soft tissues. For high-volume low-pressure polyvinyl chloride cuffs the leakage rate was >50% lower in the bio-inspired tracheal model compared with the rigid cylinder model (151 [8] vs 261 [11] ml h−1). For high-volume low-pressure polyurethane cuffs, much lower leakage rates were observed than polyvinyl chloride cuffs in both models with leakage rates higher for the bio-inspired trachea model (0.1 [0.2] vs 0 [0] ml h−1).

Conclusion

A reproducible tracheal model that incorporates the mechanical properties of the human trachea can be manufactured from segmented CT images and additive manufactured moulds, providing a useful tool to inform future cuff development, leakage testing for industrial applications, and clinical decision-making. There are differences between cuff leakage rates between the bio-inspired model and the rigid cylinder recommended in EN ISO 5361:2023. The bio-inspired model could lead to more accurate and realistic cuff leakage rate testing which would support manufacturers in refining their designs. Clinicians would then be able to choose better tracheal tubes based on the outcomes of this testing.

导言口腔分泌物通过气管导管充气罩囊泄漏是导致呼吸机相关性肺炎的一个因素。麻醉和呼吸设备国际标准》(EN ISO 5361:2023)中规定的当前测试袖带泄漏的台架测试方法涉及使用气管的玻璃或塑料硬质圆柱体模型。我们利用人体计算机断层扫描数据和增材制造(3D 打印)技术,结合铸造技术,制造出具有类似组织特征的生物启发合成气管模型。我们根据 EN ISO 5361:2023 标准进行了充气罩囊泄漏测试,并比较了硬质圆柱体气管与我们的生物启发模型之间的高容量低压聚氯乙烯和聚氨酯充气罩囊的测试结果。对于大容量低压聚氯乙烯袖套,生物启发气管模型的泄漏率比刚性圆柱体模型低 50%(151 [8] vs 261 [11] ml h-1)。对于高容量低压聚氨酯袖带,在两种模型中观察到的泄漏率都比聚氯乙烯袖带低得多,而生物启发气管模型的泄漏率更高(0.1 [0.2] vs 0 [0] ml h-1)。生物启发模型与 EN ISO 5361:2023 推荐的硬质圆柱体之间的袖带泄漏率存在差异。生物启发模型可以带来更准确、更真实的袖带泄漏率测试,从而为制造商改进设计提供支持。这样,临床医生就能根据测试结果选择更好的气管导管。
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引用次数: 0
Cardiopulmonary exercise variables and their association with postoperative morbidity and mortality after major oesophagogastric cancer surgery—a multicentre observational study 心肺运动变量及其与食管胃癌大手术后发病率和死亡率的关系--一项多中心观察研究
Pub Date : 2024-06-01 DOI: 10.1016/j.bjao.2024.100289
Malcolm A. West , Saqib Rahman , Sandy Jack , Michael P.W. Grocott , Denny Z.H. Levett , the Perioperative Exercise Testing and Training Society (POETTS), Yasir Rashid , John Griffiths , Martin Ezra , Lyndsay Ayres , Helen Neville-Webbe , Muhammad Shafiq Javed , Milind Shrotri , Iftikhar Khan , David Whitmore , Pradeep Prabhu , David Timbrell , Sophie Allen , Andrew O. Packham , David Sharpe , Mark Edwards

Background

Outcomes after oesophagogastric cancer surgery remain poor. Cardiopulmonary exercise testing (CPET) used for risk stratification before oesophagogastric cancer surgery is based on conflicting evidence. This study explores the relationship between CPET and postoperative outcomes, specifically for patients undergoing neoadjuvant treatment.

Methods

Patients undergoing oesophagogastric cancer resection and CPET (pre- or post-neoadjuvant treatment, or both) were retrospectively enrolled into a multicentre pooled cohort study. Oxygen uptake at peak exercise (VO2 peak) was compared with 1-yr postoperative survival. Secondary analyses explored relationships between patient characteristics, tumour pathology characteristics, CPET variables (absolute, relative to weight, ideal body weight, and body surface area), and postoperative outcomes (morbidity, 1-yr and 3-yr survival) were assessed using logistic regression analyses.

Results

Seven UK centres recruited 611 patients completing a 3-yr postoperative follow-up period. Oesophagectomy was undertaken in 475 patients (78%). Major complications occurred in 25%, with 18% 1-yr and 43% 3-yr mortality. No association between VO2 peak or other selected CPET variables and 1-yr survival was observed in the overall cohort. In the overall cohort, the anaerobic threshold relative to ideal body weight was associated with 3-yr survival (P=0.013). Tumour characteristics (ypT/ypN/tumour regression/lymphovascular invasion/resection margin; P<0.001) and Clavien–Dindo ≥3a (P<0.001) were associated with 1-yr and 3-yr survival. On subgroup analyses, pre-neoadjuvant treatment CPET; anaerobic threshold (absolute; P=0.024, relative to ideal body weight; P=0.001, body surface area; P=0.009) and VE/VCO2 at anaerobic threshold (P=0.026) were associated with 3-yr survival. No other CPET variables (pre- or post-neoadjuvant treatment) were associated with survival.

Conclusions

VO2 peak was not associated with 1-yr survival after oesophagogastric cancer resection. Tumour characteristics and major complications were associated with survival; however, only some selected pre-neoadjuvant treatment CPET variables were associated with 3-yr survival. CPET in this cohort of patients demonstrates limited outcome predictive precision.

Clinical trial registration

NCT03637647.

背景食管胃癌手术后的疗效仍然不佳。食管胃癌手术前用于风险分层的心肺运动测试(CPET)基于相互矛盾的证据。本研究探讨了 CPET 与术后预后之间的关系,特别是对接受新辅助治疗的患者的影响。方法回顾性地将接受食管胃癌切除术和 CPET(新辅助治疗前或后,或两者)的患者纳入一项多中心集合队列研究。将运动峰值摄氧量(VO2 峰值)与术后 1 年生存率进行了比较。二次分析探讨了患者特征、肿瘤病理特征、CPET变量(绝对值、相对体重、理想体重和体表面积)与术后结果(发病率、1年和3年生存率)之间的关系,并使用逻辑回归分析进行了评估。475名患者(78%)接受了食管切除术。25%的患者出现主要并发症,1年死亡率为18%,3年死亡率为43%。在总体队列中,未观察到 VO2 峰值或其他选定 CPET 变量与 1 年生存率之间存在关联。在整个队列中,相对于理想体重的无氧阈值与 3 年生存率相关(P=0.013)。肿瘤特征(ypT/ypN/肿瘤回归/淋巴管侵犯/切缘;P<0.001)和 Clavien-Dindo ≥3a(P<0.001)与 1 年和 3 年生存率相关。在亚组分析中,新辅助治疗前 CPET、无氧阈值(绝对值;P=0.024,相对于理想体重;P=0.001,体表面积;P=0.009)和无氧阈值时的 VE/VCO2 (P=0.026)与 3 年生存率相关。结论VO2峰值与食管胃癌切除术后的1年生存率无关。肿瘤特征和主要并发症与生存率有关;但是,只有一些选定的新辅助治疗前 CPET 变量与 3 年生存率有关。该组患者的 CPET 结果预测精确度有限。
{"title":"Cardiopulmonary exercise variables and their association with postoperative morbidity and mortality after major oesophagogastric cancer surgery—a multicentre observational study","authors":"Malcolm A. West ,&nbsp;Saqib Rahman ,&nbsp;Sandy Jack ,&nbsp;Michael P.W. Grocott ,&nbsp;Denny Z.H. Levett ,&nbsp;the Perioperative Exercise Testing and Training Society (POETTS),&nbsp;Yasir Rashid ,&nbsp;John Griffiths ,&nbsp;Martin Ezra ,&nbsp;Lyndsay Ayres ,&nbsp;Helen Neville-Webbe ,&nbsp;Muhammad Shafiq Javed ,&nbsp;Milind Shrotri ,&nbsp;Iftikhar Khan ,&nbsp;David Whitmore ,&nbsp;Pradeep Prabhu ,&nbsp;David Timbrell ,&nbsp;Sophie Allen ,&nbsp;Andrew O. Packham ,&nbsp;David Sharpe ,&nbsp;Mark Edwards","doi":"10.1016/j.bjao.2024.100289","DOIUrl":"https://doi.org/10.1016/j.bjao.2024.100289","url":null,"abstract":"<div><h3>Background</h3><p>Outcomes after oesophagogastric cancer surgery remain poor. Cardiopulmonary exercise testing (CPET) used for risk stratification before oesophagogastric cancer surgery is based on conflicting evidence. This study explores the relationship between CPET and postoperative outcomes, specifically for patients undergoing neoadjuvant treatment.</p></div><div><h3>Methods</h3><p>Patients undergoing oesophagogastric cancer resection and CPET (pre- or post-neoadjuvant treatment, or both) were retrospectively enrolled into a multicentre pooled cohort study. Oxygen uptake at peak exercise (VO<sub>2</sub> peak) was compared with 1-yr postoperative survival. Secondary analyses explored relationships between patient characteristics, tumour pathology characteristics, CPET variables (absolute, relative to weight, ideal body weight, and body surface area), and postoperative outcomes (morbidity, 1-yr and 3-yr survival) were assessed using logistic regression analyses.</p></div><div><h3>Results</h3><p>Seven UK centres recruited 611 patients completing a 3-yr postoperative follow-up period. Oesophagectomy was undertaken in 475 patients (78%). Major complications occurred in 25%, with 18% 1-yr and 43% 3-yr mortality. No association between VO<sub>2</sub> peak or other selected CPET variables and 1-yr survival was observed in the overall cohort. In the overall cohort, the anaerobic threshold relative to ideal body weight was associated with 3-yr survival (<em>P</em>=0.013). Tumour characteristics (ypT/ypN/tumour regression/lymphovascular invasion/resection margin; <em>P</em>&lt;0.001) and Clavien–Dindo ≥3a (<em>P</em>&lt;0.001) were associated with 1-yr and 3-yr survival. On subgroup analyses, pre-neoadjuvant treatment CPET; anaerobic threshold (absolute; <em>P</em>=0.024, relative to ideal body weight; <em>P</em>=0.001, body surface area; <em>P</em>=0.009) and V<sub>E</sub>/VCO<sub>2</sub> at anaerobic threshold (<em>P</em>=0.026) were associated with 3-yr survival. No other CPET variables (pre- or post-neoadjuvant treatment) were associated with survival.</p></div><div><h3>Conclusions</h3><p>VO<sub>2</sub> peak was not associated with 1-yr survival after oesophagogastric cancer resection. Tumour characteristics and major complications were associated with survival; however, only some selected pre-neoadjuvant treatment CPET variables were associated with 3-yr survival. CPET in this cohort of patients demonstrates limited outcome predictive precision.</p></div><div><h3>Clinical trial registration</h3><p>NCT03637647.</p></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"10 ","pages":"Article 100289"},"PeriodicalIF":0.0,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2772609624000339/pdfft?md5=7e7856a662577fb327cd5c4ab34f09ca&pid=1-s2.0-S2772609624000339-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141289567","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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