Strametz Reinhard, Pachler Christoph, Kramer Johanna F, Byhahn Christian, Siebenhofer Andrea, Weberschock Tobias
Evidence-Based Medicine Frankfurt, Institute of General Practice, Goethe University, Theodor-Stern-Kai 7, Frankfurt, Germany, 60590.
Cochrane Database Syst Rev. 2014 Jun 30;2014(6):CD009901. doi: 10.1002/14651858.CD009901.pub2.
Percutaneous dilatational tracheostomy (PDT) is one of the most common bedside surgical procedures performed in critically ill adult patients on intensive care units (ICUs) who require long-term ventilation. PDT is generally associated with relevant life-threatening complications (e.g. cuff rupture leading to possible hypoxia or aspiration, puncture of the oesophagus, accidental extubation, mediastinitis, pneumothorax, emphysema). The patient's airway can be secured with an endotracheal tube (ETT) or a laryngeal mask airway (LMA).
To assess the safety and effectiveness of ETT versus LMA in critically ill adult patients undergoing PDT on the ICU.This review addresses the following research questions.1. Is an LMA more effective than an ETT in terms of procedure-related or all-cause mortality?2. Is an LMA safer than an ETT in terms of procedure-related life-threatening complications during a PDT procedure?3. Does use of an LMA influence the conditions for performing a tracheostomy (e.g. duration of procedure)?
We searched the Cochrane Database of Systematic Reviews (CDSR); the Cochrane Central Register of Controlled Trials (CENTRAL) 2013, Issue 6 (part ofThe Cochrane Library); MEDLINE (from 1984 to 27 June 2013) and EMBASE (from 1984 to 27 June 2013). We searched for reports of ongoing trials in the metaRegister of Controlled Trials (mRCT). We handsearched for relevant studies in conference proceedings of the International Symposium on Intensive Care and Emergency Medicine (ISICEM), the Annual Congress of the European Society of Intensive Care Medicine (ESICM), the Annual Congress of the Society of Critical Care Medicine (SCCM), the American Thoracic Society (ATS) and the Annual Meeting of the American College of Chest Physicians (ACCP). We contacted study authors and experts concerning unpublished data and ongoing trials. We searched for further relevant studies in the reference lists of all included trials and of relevant systematic reviews identified in theCDSR.
We included randomized controlled trials (RCTs) that compared use of endotracheal tubes versus laryngeal mask airways in critically ill adult patients undergoing PDT on the ICU. We imposed no restrictions with regard to language, timing or technique of PDT performed.
Two review authors independently assessed the eligibility and methodological quality of each study and carried out data extraction. We resolved disagreements by discussion. Our primary outcomes were all-cause mortality, procedure-related mortality and tally of participants with one or more serious adverse events. When available, we reported on our secondary outcomes, which included duration of the procedure, failure of the procedure requiring conversion to any other procedure, time to extubation after tracheostomy, length of ICU stay after tracheostomy, length of hospital stay after tracheostomy and any other serious adverse events. When possible, we combined homogeneous studies for meta-analysis. We used the risk of bias tool of The Cochrane Collaboration to assess the internal validity of all included studies in six different domains.
We included in this review eight RCTs involving 467 participants. The included trials exclusively assessed critically ill participants (e.g. with head injury, neurological disease, multi-trauma, sepsis, acute respiratory failure (ARF) and/or chronic obstructive pulmonary disease (COPD)). Internal validity was considerably low in studies with a high or unclear risk of bias. The main reason for this was low methodological quality or missing data, even after study authors were contacted. Study size was generally small, with a minimum of 40 and a maximum of 73 participants. Only one study (40 participants) reported on overall mortality, showing no clear evidence of a difference between treatment groups (risk ratio (RR) 1.5, 95% confidence interval (CI) 0.28 to 8.04, Fisher test P value 1.0, low-quality evidence). Four studies (231 participants) reported that no procedure-related deaths occurred with any intervention. Seven studies reported the numbers of participants with adverse events, showing no clear evidence of benefit of either LMA or ETT during PDT (RR 0.73, 95% CI 0.35 to 1.52, P value 0.41, low-quality evidence). The tally of participants in included studies with adverse events ranged from 0% to 33% in the LMA group and from 0% to 50% in the ETT group. However, the duration of the procedure was significantly shorter in the LMA group (mean difference (MD) -1.46 minutes, 95% CI -1.92 to -1.01 minutes, 324 participants, P value ≤ 0.00001, low-quality evidence). No clear evidence of a difference between ETT and LMA groups was found for all other outcomes. Only one study provided follow-up data for late complications related to the intervention, showing no clear evidence of benefit for any treatment group.
AUTHORS' CONCLUSIONS: Evidence on the safety of LMA for PDT is too limited to allow conclusions to be drawn on its efficacy or safety compared with ETT. Although the LMA procedure is shorter because of optimal visual conditions, its effect on especially late complications has not been investigated sufficiently. Studies focusing on late complications and relevant patient-related outcomes are necessary for definitive conclusions on safety issues related to this procedure.
经皮扩张气管切开术(PDT)是重症监护病房(ICU)中对需要长期通气的成年危重病患者实施的最常见的床边手术之一。PDT通常会引发相关的危及生命的并发症(例如,套管破裂导致可能的缺氧或误吸、食管穿刺、意外拔管、纵隔炎、气胸、肺气肿)。可通过气管内插管(ETT)或喉罩气道(LMA)确保患者气道安全。
评估在ICU接受PDT的成年危重病患者中,ETT与LMA相比的安全性和有效性。本综述探讨以下研究问题。1. 在与手术相关的死亡率或全因死亡率方面,LMA是否比ETT更有效?2. 在PDT手术期间,就与手术相关的危及生命的并发症而言,LMA是否比ETT更安全?3. 使用LMA是否会影响气管切开术的实施条件(例如手术持续时间)?
我们检索了Cochrane系统评价数据库(CDSR);Cochrane对照试验中央注册库(CENTRAL)2013年第6期(Cochrane图书馆的一部分);MEDLINE(1984年至2013年6月27日)和EMBASE(1984年至2013年6月27日)。我们在对照试验元注册库(mRCT)中检索正在进行的试验报告。我们手工检索了国际重症监护与急诊医学研讨会(ISICEM)、欧洲重症监护医学学会年会(ESICM)、危重病医学学会年会(SCCM)、美国胸科学会(ATS)和美国胸科医师学会年会(ACCP)的会议论文集中的相关研究。我们就未发表的数据和正在进行的试验联系了研究作者和专家。我们在所有纳入试验的参考文献列表以及CDSR中识别出的相关系统评价的参考文献列表中检索了进一步的相关研究。
我们纳入了比较在ICU接受PDT的成年危重病患者中气管内插管与喉罩气道使用情况的随机对照试验(RCT)。我们对PDT实施的语言、时间或技术未作限制。
两位综述作者独立评估每项研究的合格性和方法学质量,并进行数据提取。我们通过讨论解决分歧。我们的主要结局是全因死亡率、与手术相关的死亡率以及发生一项或多项严重不良事件的参与者计数。如有可用数据,我们报告次要结局,包括手术持续时间、需要转换为任何其他手术的手术失败情况、气管切开术后拔管时间、气管切开术后ICU住院时间、气管切开术后住院时间以及任何其他严重不良事件。如有可能,我们对同类研究进行合并以进行荟萃分析。我们使用Cochrane协作网的偏倚风险工具在六个不同领域评估所有纳入研究的内部效度。
我们在本综述中纳入了八项RCT,涉及467名参与者。纳入的试验专门评估了危重病参与者(例如,患有头部损伤、神经疾病、多发伤、脓毒症、急性呼吸衰竭(ARF)和/或慢性阻塞性肺疾病(COPD))。在偏倚风险高或不明确的研究中,内部效度相当低。主要原因是方法学质量低或数据缺失,即使在联系研究作者之后也是如此。研究规模一般较小,最少40名参与者,最多73名参与者。只有一项研究(40名参与者)报告了总体死亡率,未显示治疗组之间存在明显差异的证据(风险比(RR)1.5,95%置信区间(CI)0.28至8.04,Fisher检验P值1.0,低质量证据)。四项研究(231名参与者)报告称,任何干预措施均未发生与手术相关的死亡。七项研究报告了发生不良事件的参与者数量,未显示在PDT期间LMA或ETT有明显益处的证据(RR 0.73,95%CI 0.35至1.52,P值0.41,低质量证据)。纳入研究中LMA组发生不良事件的参与者计数范围为0%至33%,ETT组为0%至50%。然而,LMA组的手术持续时间明显更短(平均差(MD)-1.46分钟,95%CI -1.92至-1.01分钟,324名参与者,P值≤0.00001,低质量证据)。对于所有其他结局,未发现ETT组和LMA组之间存在明显差异的证据。只有一项研究提供了与干预相关的晚期并发症的随访数据,未显示任何治疗组有明显益处的证据。
关于LMA用于PDT的安全性的证据过于有限,无法就其与ETT相比的疗效或安全性得出结论。尽管由于视觉条件最佳,LMA手术时间较短,但其对尤其是晚期并发症的影响尚未得到充分研究。需要开展关注晚期并发症和相关患者相关结局的研究,以便就与该手术相关的安全问题得出明确结论。