Early versus late tracheostomy in people with multiple trauma.

IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Kelly Ansems, Eva Steinfeld, Nicole Skoetz, Elena Aleksandrova, Maria-Inti Metzendorf, Thomas Breuer, Carina Benstoem, Sandra Dohmen
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This review was initiated during the development of the Association of the Scientific Medical Societies in Germany (AWMF) S3 guideline 'Intensivmedizin nach Polytrauma' (intensive care after multiple trauma) to systematically assess the effects of early versus late tracheostomy in people with multiple trauma in the ICU.</p><p><strong>Objectives: </strong>To assess the benefits and harms of early tracheostomy compared with late tracheostomy in adults with multiple trauma in the intensive care unit.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Web of Science, ClinicalTrials.gov, and WHO ICTRP from inception to 15 March 2024 without language restrictions. We also screened reference lists and contacted experts in the field.</p><p><strong>Eligibility criteria: </strong>We followed standard Cochrane methodology. We included randomised controlled trials (RCTs) and non-randomised studies of interventions (NRSIs) comparing early and late tracheostomy, defined according to any cutoff time point, in critically ill adults with multiple trauma, irrespective of sex, ethnicity, disease severity, or setting. We excluded studies published as abstract only, studies recruiting people with only one type of trauma, and studies recruiting people who needed immediate tracheostomy.</p><p><strong>Outcomes: </strong>The critical outcome was all-cause mortality. Important outcomes included duration of stay (ICU or hospital), quality of life, pulmonary complications, adverse events, and time from tracheostomy to decannulation.</p><p><strong>Risk of bias: </strong>We used Cochrane risk of bias tools (RoB 2 for RCTs and ROBINS-I for NRSIs) to assess risk of bias at the outcome level.</p><p><strong>Synthesis methods: </strong>Our meta-analyses used a random-effects model. 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NRSI data suggested that early tracheostomy compared with late tracheostomy may have little to no effect on all-cause mortality (adjusted hazard ratio (HR) 0.96, 95% CI 0.49 to 1.88) or rate of ventilator-associated pneumonia (unadjusted RR 1.10, 95% CI 0.78 to 1.56). One NRSI with adjusted data suggested that early tracheostomy may reduce ICU length of stay (1/HR 0.57, 95% CI 0.46 to 0.71), while unadjusted data from two NRSIs suggested that early tracheostomy may increase in-hospital mortality (RR 1.20, 95% CI 1.06 to 1.36; odds ratio (OR) 1.22, 95% CI 1.05 to 1.41). The evidence for all these outcomes was very uncertain. The certainty of the evidence was consistently rated as very low across outcomes. The most common reason for downgrading was imprecision, due to small sample sizes, wide CIs including both benefit and harm, and analyses including data from only one study. In NRSIs, additional downgrades were due to serious risk of bias, particularly related to potential confounding and unclear adjustment for baseline differences. We identified one ongoing trial.</p><p><strong>Authors' conclusions: </strong>Early tracheostomy (< 10 days after intubation) may have little to no effect on all-cause mortality, ICU length of stay, or rate of pneumonia compared with late tracheostomy (≥ 10 days), but the evidence is very uncertain. No data were available on quality of life, adverse events, or time from tracheostomy to decannulation. Adjusted NRSI data suggest that early tracheostomy may reduce ICU length of stay, but the evidence is very uncertain. Given the limited RCT data and the heterogeneity of NRSIs, future research should focus on standardising definitions of multiple trauma and timing of tracheostomy, while also addressing equity by including diverse populations and settings. 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引用次数: 0

Abstract

Rationale: According to TraumaRegister DGU (the trauma registry of the German Trauma Society), 83% of trauma patients are admitted to an intensive care unit (ICU), with 34.8% receiving mechanical ventilation. However, specific data for people with multiple trauma are lacking. Prolonged ventilation due to acute respiratory failure or difficult weaning are common indications for tracheostomy in critically ill people. Despite numerous studies, the optimal timing for tracheostomy remains unclear. This review was initiated during the development of the Association of the Scientific Medical Societies in Germany (AWMF) S3 guideline 'Intensivmedizin nach Polytrauma' (intensive care after multiple trauma) to systematically assess the effects of early versus late tracheostomy in people with multiple trauma in the ICU.

Objectives: To assess the benefits and harms of early tracheostomy compared with late tracheostomy in adults with multiple trauma in the intensive care unit.

Search methods: We searched CENTRAL, MEDLINE, Web of Science, ClinicalTrials.gov, and WHO ICTRP from inception to 15 March 2024 without language restrictions. We also screened reference lists and contacted experts in the field.

Eligibility criteria: We followed standard Cochrane methodology. We included randomised controlled trials (RCTs) and non-randomised studies of interventions (NRSIs) comparing early and late tracheostomy, defined according to any cutoff time point, in critically ill adults with multiple trauma, irrespective of sex, ethnicity, disease severity, or setting. We excluded studies published as abstract only, studies recruiting people with only one type of trauma, and studies recruiting people who needed immediate tracheostomy.

Outcomes: The critical outcome was all-cause mortality. Important outcomes included duration of stay (ICU or hospital), quality of life, pulmonary complications, adverse events, and time from tracheostomy to decannulation.

Risk of bias: We used Cochrane risk of bias tools (RoB 2 for RCTs and ROBINS-I for NRSIs) to assess risk of bias at the outcome level.

Synthesis methods: Our meta-analyses used a random-effects model. Our main comparison was early tracheostomy (< 10 days) versus late tracheostomy (≥ 10 days) after intubation. Because the timing of early tracheostomy varied considerably across studies, we explored the impact of different timings in subgroup analyses. We used the GRADE approach to assess the certainty of evidence.

Included studies: We included one RCT (60 participants) and 22 NRSIs (44,811 participants). The RCT was a single-centre, parallel-group trial conducted in the USA over 38 months. It was halted prematurely after the first interim analysis. Most NRSIs (91%) were retrospective. Six studies, including the RCT, specifically addressed our main comparison (< 10 days vs ≥ 10 days).

Synthesis of results: Evidence from the RCT (60 participants) suggested that early tracheostomy (< 10 days) compared with late tracheostomy (≥ 10 days) may have little to no effect on all-cause mortality (risk ratio (RR) 0.43, 95% confidence interval (CI) 0.09 to 2.03; very low-certainty evidence), ICU length of stay (mean difference (MD) -0.30 days, 95% CI -17.64 to 17.04; very low-certainty evidence), or rate of pneumonia (RR 1.07, 95% CI 0.93 to 1.22; very low-certainty evidence), but the evidence for all three outcomes is very uncertain. No data were available for quality of life, adverse events, or time from tracheostomy to decannulation. NRSI data suggested that early tracheostomy compared with late tracheostomy may have little to no effect on all-cause mortality (adjusted hazard ratio (HR) 0.96, 95% CI 0.49 to 1.88) or rate of ventilator-associated pneumonia (unadjusted RR 1.10, 95% CI 0.78 to 1.56). One NRSI with adjusted data suggested that early tracheostomy may reduce ICU length of stay (1/HR 0.57, 95% CI 0.46 to 0.71), while unadjusted data from two NRSIs suggested that early tracheostomy may increase in-hospital mortality (RR 1.20, 95% CI 1.06 to 1.36; odds ratio (OR) 1.22, 95% CI 1.05 to 1.41). The evidence for all these outcomes was very uncertain. The certainty of the evidence was consistently rated as very low across outcomes. The most common reason for downgrading was imprecision, due to small sample sizes, wide CIs including both benefit and harm, and analyses including data from only one study. In NRSIs, additional downgrades were due to serious risk of bias, particularly related to potential confounding and unclear adjustment for baseline differences. We identified one ongoing trial.

Authors' conclusions: Early tracheostomy (< 10 days after intubation) may have little to no effect on all-cause mortality, ICU length of stay, or rate of pneumonia compared with late tracheostomy (≥ 10 days), but the evidence is very uncertain. No data were available on quality of life, adverse events, or time from tracheostomy to decannulation. Adjusted NRSI data suggest that early tracheostomy may reduce ICU length of stay, but the evidence is very uncertain. Given the limited RCT data and the heterogeneity of NRSIs, future research should focus on standardising definitions of multiple trauma and timing of tracheostomy, while also addressing equity by including diverse populations and settings. More high-quality studies are needed to confirm possible benefits of early tracheostomy, with particular attention to adjusted analyses and outcomes such as mortality, ICU length of stay, and pulmonary complications. Further studies should also explore the long-term effects of tracheostomy on survival, quality of life, and functional outcomes to guide evidence-based clinical decision-making in multiple trauma care.

Funding: Internal funding.

Registration: Protocol: doi.org/10.1002/14651858.CD015932.

多发创伤患者早期与晚期气管切开术的比较。
理由:根据德国创伤学会创伤登记处DGU的数据,83%的创伤患者入住重症监护病房(ICU), 34.8%的患者接受机械通气。然而,缺乏针对多重创伤患者的具体数据。因急性呼吸衰竭或难以脱机而延长通气时间是危重患者气管切开术的常见适应症。尽管有大量的研究,气管切开术的最佳时机仍不清楚。本综述是在德国科学医学学会协会(AWMF) S3指南“多重创伤后的重症监护”(Intensivmedizin nach Polytrauma)的制定过程中发起的,目的是系统地评估早期和晚期气管切开术对ICU多重创伤患者的影响。目的:比较重症监护病房成人多发创伤患者早期气管切开术与晚期气管切开术的利弊。检索方法:我们检索了CENTRAL、MEDLINE、Web of Science、ClinicalTrials.gov和WHO ICTRP,检索时间从成立到2024年3月15日,没有语言限制。我们还筛选了参考书目并联系了该领域的专家。入选标准:我们遵循标准Cochrane方法学。我们纳入了随机对照试验(RCTs)和非随机干预研究(NRSIs),比较早期和晚期气管切开术,根据任何截止时间点定义,在多重创伤的危重成人中,无论性别、种族、疾病严重程度或环境如何。我们排除了仅以摘要形式发表的研究,仅招募一种创伤患者的研究,以及招募需要立即气管切开术的研究。结局:关键结局为全因死亡率。重要结局包括住院时间(ICU或医院)、生活质量、肺部并发症、不良事件以及从气管切开到脱管的时间。偏倚风险:我们使用Cochrane偏倚风险工具(rct的rob2和nsis的ROBINS-I)来评估结果水平的偏倚风险。综合方法:我们的荟萃分析采用随机效应模型。我们的主要比较是插管后早期气管造口术(< 10天)和晚期气管造口术(≥10天)。由于不同研究的早期气管切开术时间差异很大,我们在亚组分析中探讨了不同时间的影响。我们使用GRADE方法来评估证据的确定性。纳入的研究:我们纳入了1项RCT(60名受试者)和22项NRSIs(44,811名受试者)。该随机对照试验是在美国进行的一项为期38个月的单中心、平行组试验。在第一次中期分析后,它被提前停止了。大多数nrsi(91%)是回顾性的。包括随机对照试验在内的6项研究专门针对我们的主要比较(< 10天vs≥10天)。结果综合:来自随机对照试验(60名受试者)的证据表明,早期气管造口术(< 10天)与晚期气管造口术(≥10天)相比,可能对全因死亡率影响很小或没有影响(风险比(RR) 0.43, 95%可信区间(CI) 0.09 ~ 2.03;极低确定性证据),ICU住院时间(平均差(MD) -0.30天,95% CI -17.64至17.04;极低确定性证据)或肺炎发生率(RR 1.07, 95% CI 0.93至1.22;非常低确定性的证据),但这三种结果的证据都非常不确定。没有关于生活质量、不良事件或从气管切开到脱管时间的数据。NRSI数据显示,早期气管切开术与晚期气管切开术相比,可能对全因死亡率(校正风险比(HR) 0.96, 95% CI 0.49至1.88)或呼吸机相关肺炎发生率(未校正RR 1.10, 95% CI 0.78至1.56)影响很小或没有影响。一项经调整数据的NRSI显示,早期气管切开术可能缩短ICU住院时间(1/HR 0.57, 95% CI 0.46 ~ 0.71),而两项未经调整的NRSI数据显示,早期气管切开术可能增加住院死亡率(RR 1.20, 95% CI 1.06 ~ 1.36;优势比(OR) 1.22, 95% CI 1.05 ~ 1.41)。所有这些结果的证据都非常不确定。在所有结果中,证据的确定性一直被评为非常低。降级最常见的原因是不精确,因为样本量小,包括益处和危害的广泛ci,以及分析只包括一项研究的数据。在nrsi中,额外的降级是由于严重的偏倚风险,特别是与潜在的混淆和基线差异调整不明确有关。我们确定了一个正在进行的试验。作者的结论是:与晚期气管造口术(≥10天)相比,早期气管造口术(插管后< 10天)对全因死亡率、ICU住院时间或肺炎发生率的影响可能很小或没有影响,但证据非常不确定。没有关于生活质量、不良事件或从气管切开术到脱管时间的数据。 调整后的NRSI数据表明,早期气管切开术可能会缩短ICU的住院时间,但证据非常不确定。鉴于有限的RCT数据和nrsi的异质性,未来的研究应侧重于标准化多重创伤的定义和气管切开术的时机,同时通过纳入不同的人群和环境来解决公平性问题。需要更多高质量的研究来证实早期气管切开术可能带来的益处,特别要注意调整后的分析和结果,如死亡率、ICU住院时间和肺部并发症。进一步的研究还应探讨气管切开术对生存、生活质量和功能结局的长期影响,以指导基于证据的临床决策在多重创伤护理中。资金:内部资金。注册:协议:doi.org/10.1002/14651858.CD015932。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
10.60
自引率
2.40%
发文量
173
审稿时长
1-2 weeks
期刊介绍: The Cochrane Database of Systematic Reviews (CDSR) stands as the premier database for systematic reviews in healthcare. It comprises Cochrane Reviews, along with protocols for these reviews, editorials, and supplements. Owned and operated by Cochrane, a worldwide independent network of healthcare stakeholders, the CDSR (ISSN 1469-493X) encompasses a broad spectrum of health-related topics, including health services.
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