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用于预防成人围手术期意外低温引起并发症的主动体表升温系统。

Active body surface warming systems for preventing complications caused by inadvertent perioperative hypothermia in adults.

作者信息

Madrid Eva, Urrútia Gerard, Roqué i Figuls Marta, Pardo-Hernandez Hector, Campos Juan Manuel, Paniagua Pilar, Maestre Luz, Alonso-Coello Pablo

机构信息

Biomedical Research Centre, School of Medicine - Universidad de Valparaiso, Valparaiso, Chile.

出版信息

Cochrane Database Syst Rev. 2016 Apr 21;4(4):CD009016. doi: 10.1002/14651858.CD009016.pub2.


DOI:10.1002/14651858.CD009016.pub2
PMID:27098439
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8687605/
Abstract

BACKGROUND: Inadvertent perioperative hypothermia is a phenomenon that can occur as a result of the suppression of the central mechanisms of temperature regulation due to anaesthesia, and of prolonged exposure of large surfaces of skin to cold temperatures in operating rooms. Inadvertent perioperative hypothermia has been associated with clinical complications such as surgical site infection and wound-healing delay, increased bleeding or cardiovascular events. One of the most frequently used techniques to prevent inadvertent perioperative hypothermia is active body surface warming systems (ABSW), which generate heat mechanically (heating of air, water or gels) that is transferred to the patient via skin contact. OBJECTIVES: To assess the effectiveness of pre- or intraoperative active body surface warming systems (ABSW), or both, to prevent perioperative complications from unintended hypothermia during surgery in adults. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 9, 2015); MEDLINE (PubMed) (1964 to October 2015), EMBASE (Ovid) (1980 to October 2015), and CINAHL (Ovid) (1982 to October 2015). SELECTION CRITERIA: We included randomized controlled trials (RCTs) that compared an ABSW system aimed at maintaining normothermia perioperatively against a control or against any other ABSW system. Eligible studies also had to include relevant clinical outcomes other than measuring temperature alone. DATA COLLECTION AND ANALYSIS: Several authors, by pairs, screened references and determined eligibility, extracted data, and assessed risks of bias. We resolved disagreements by discussion and consensus, with the collaboration of a third author. MAIN RESULTS: We included 67 trials with 5438 participants that comprised 79 comparisons. Forty-five RCTs compared ABSW versus control, whereas 18 compared two different types of ABSW, and 10 compared two different techniques to administer the same type of ABSW. Forced-air warming (FAW) was by far the most studied intervention.Trials varied widely regarding whether the interventions were applied alone or in combination with other active (based on a different mechanism of heat transfer) and/or passive methods of maintaining normothermia. The type of participants and surgical interventions, as well as anaesthesia management, co-interventions and the timing of outcome measurement, also varied widely. The risk of bias of included studies was largely unclear due to limitations in the reports. Most studies were open-label, due to the nature of the intervention and the fact that temperature was usually the principal outcome. Nevertheless, given that outcome measurement could have been conducted in a blinded manner, we rated the risk of detection and performance bias as high.The comparison of ABSW versus control showed a reduction in the rate of surgical site infection (risk ratio (RR) 0.36, 95% confidence interval (CI) 0.20 to 0.66; 3 RCTs, 589 participants, low-quality evidence). Only one study at low risk of bias observed a beneficial effect with forced-air warming on major cardiovascular complications (RR 0.22, 95% CI 0.05 to 1.00; 1 RCT with 12 events, 300 participants, low-quality evidence) in people at high cardiovascular risk. We found no beneficial effect for mortality. ABSW also reduced blood loss during surgery but the magnitude of this effect seems to be irrelevant (MD -46.17 mL, 95% CI -82.74 to -9.59; I² = 78%; 20 studies, 1372 participants). The same conclusion applies to total fluids infused during surgery (MD -144.49 mL, 95% CI -221.57 to -67.40; I² = 73%; 24 studies, 1491 participants). These effects did not translate into a significant reduction in the number of participants being transfused or the average amount of blood transfused. ABSW was associated with a reduction in shivering (RR 0.39, 95% CI 0.28 to 0.54; 29 studies, 1922 participants) and in thermal comfort (standardized mean difference (SMD) 0.76, 95% CI 0.29 to 1.24; I² = 77%, 4 trials, 364 participants).For the comparison between different types of ABSW system or modes of administration of a particular type of ABSW, we found no evidence for the superiority of any system in terms of clinical outcomes, except for extending systemic warming to the preoperative period in participants undergoing major abdominal surgery (one study at low risk of bias).There were limited data on adverse effects (the most relevant being thermal burns). While some trials included a narrative report mentioning that no adverse effects were observed, the majority made no reference to it. Nothing so far suggests that ABSW involves a significant risk to patients. AUTHORS' CONCLUSIONS: Forced-air warming seems to have a beneficial effect in terms of a lower rate of surgical site infection and complications, at least in those undergoing abdominal surgery, compared to not applying any active warming system. It also has a beneficial effect on major cardiovascular complications in people with substantial cardiovascular disease, although the evidence is limited to one study. It also improves patient's comfort, although we found high heterogeneity among trials. While the effect on blood loss is statistically significant, this difference does not translate to a significant reduction in transfusions. Again, we noted high heterogeneity among trials for this outcome. The clinical relevance of blood loss reduction is therefore questionable. The evidence for other types of ABSW is scant, although there is some evidence of a beneficial effect in the same direction on chills/shivering with electric or resistive-based heating systems. Some evidence suggests that extending systemic warming to the preoperative period could be more beneficial than limiting it only to during surgery. Nothing suggests that ABSW systems pose a significant risk to patients.The difficulty in observing a clinically-relevant beneficial effect with ABSW in outcomes other than temperature may be explained by the fact that many studies applied concomitant procedures that are routinely in place as co-interventions to prevent hypothermia, whether passive or active warming systems based in other physiological mechanisms (e.g. irrigation fluid or gas warming), as well as a stricter control of temperature in the context of the study compared with usual practice. These may have had a beneficial effect on the participants in the control group, leading to an underestimation of the net benefit of ABSW.

摘要

背景:围手术期意外低温是一种可能因麻醉导致体温调节中枢机制受抑制,以及手术室大面积皮肤长时间暴露于低温环境而出现的现象。围手术期意外低温与手术部位感染、伤口愈合延迟、出血增加或心血管事件等临床并发症相关。预防围手术期意外低温最常用的技术之一是主动体表加温系统(ABSW),该系统通过机械方式产生热量(加热空气、水或凝胶),并通过皮肤接触传递给患者。 目的:评估术前或术中使用主动体表加温系统(ABSW)或两者同时使用,对预防成人手术期间意外低温引起的围手术期并发症的有效性。 检索方法:我们检索了Cochrane对照试验中心注册库(CENTRAL;2015年第9期);MEDLINE(PubMed)(1964年至2015年10月)、EMBASE(Ovid)(1980年至2015年10月)和CINAHL(Ovid)(1982年至2015年10月)。 入选标准:我们纳入了将旨在围手术期维持正常体温的ABSW系统与对照组或任何其他ABSW系统进行比较的随机对照试验(RCT)。符合条件的研究还必须包括除单独测量体温以外的相关临床结局。 数据收集与分析:几位作者两两合作筛选参考文献、确定入选资格、提取数据并评估偏倚风险。我们通过讨论并在第三位作者的协作下达成共识来解决分歧。 主要结果:我们纳入了67项试验,共5438名参与者,包含79项比较。45项RCT将ABSW与对照组进行比较,18项比较两种不同类型的ABSW,10项比较两种不同的方法来应用同类型的ABSW。目前研究最多的干预措施是强制空气加温(FAW)。关于干预措施是单独应用还是与其他主动(基于不同热传递机制)和/或被动维持正常体温的方法联合应用,试验差异很大。参与者类型、手术干预措施以及麻醉管理、联合干预措施和结局测量时间也差异很大。由于报告存在局限性,纳入研究的偏倚风险大多不明确。由于干预措施的性质以及体温通常是主要结局这一事实,大多数研究为开放标签。然而,鉴于结局测量可以采用盲法进行,我们将检测和执行偏倚风险评为高。ABSW与对照组的比较显示手术部位感染率降低(风险比(RR)0.36,95%置信区间(CI)0.20至0.66;3项RCT,589名参与者,低质量证据)。只有一项偏倚风险较低的研究观察到强制空气加温对心血管风险较高人群的主要心血管并发症有有益作用(RR 0.22,95%CI 0.05至1.00;1项RCT,12例事件,300名参与者,低质量证据)。我们未发现对死亡率有有益作用。ABSW还减少了手术期间的失血量,但这种效果的大小似乎无关紧要(均差(MD)-46.17 mL,95%CI -82.74至-9.59;I² = 78%;20项研究,1372名参与者)。同样的结论适用于手术期间输注的总液体量(MD -144.49 mL,95%CI -221.57至-67.40;I² = 73%;24项研究,1491名参与者)。这些效果并未转化为接受输血的参与者数量或平均输血量的显著减少。ABSW与寒战减少相关(RR 0.39,95%CI 0.28至0.54;29项研究,1922名参与者)以及热舒适度提高(标准化均差(SMD)0.76,95%CI 0.29至1.24;I² = 77%,4项试验,364名参与者)。对于不同类型的ABSW系统或特定类型ABSW的给药方式之间的比较,我们未发现任何一种系统在临床结局方面具有优越性的证据,除了在接受大型腹部手术的参与者中将全身加温扩展至术前阶段(一项偏倚风险较低的研究)。关于不良反应的数据有限(最相关的是热烧伤)。虽然一些试验包含叙述性报告提及未观察到不良反应,但大多数试验未提及。目前没有任何迹象表明ABSW对患者构成重大风险。 作者结论:与不应用任何主动加温系统相比,强制空气加温似乎在降低手术部位感染率和并发症方面有有益作用,至少在接受腹部手术的患者中如此。它对患有严重心血管疾病的人群的主要心血管并发症也有有益作用,尽管证据仅限于一项研究。它还改善了患者的舒适度,尽管我们发现试验之间存在高度异质性。虽然对失血量的影响在统计学上有显著意义,但这种差异并未转化为输血的显著减少。同样,我们注意到该结局的试验之间存在高度异质性。因此,失血量减少的临床相关性值得怀疑。其他类型ABSW的证据很少,尽管有一些证据表明基于电或电阻加热系统在寒战/颤抖方面有相同方向的有益作用。一些证据表明将全身加温扩展至术前阶段可能比仅在手术期间进行加温更有益。没有任何迹象表明ABSW系统对患者构成重大风险。除体温以外的结局中,观察到ABSW具有临床相关有益作用存在困难,这可能是因为许多研究应用了常规作为联合干预措施的伴随程序来预防低温,无论是基于其他生理机制的被动或主动加温系统(如冲洗液或气体加温),以及与常规实践相比在研究背景下对体温进行更严格的控制。这些可能对对照组的参与者产生了有益作用,导致对ABSW净效益的低估。

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