Tokmaji George, Vermeulen Hester, Müller Marcella C A, Kwakman Paulus H S, Schultz Marcus J, Zaat Sebastian A J
Department of Medical Microbiology, Center for Infection and Immunity Amsterdam (CINIMA), Academic Medical Center, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands, 1105 AZ.
Cochrane Database Syst Rev. 2015 Aug 12;2015(8):CD009201. doi: 10.1002/14651858.CD009201.pub2.
Ventilator-associated pneumonia (VAP) is one of the most common nosocomial infections in intubated and mechanically ventilated patients. Endotracheal tubes (ETTs) appear to be an independent risk factor for VAP. Silver-coated ETTs slowly release silver cations. It is these silver ions that appear to have a strong antimicrobial effect. Because of this antimicrobial effect of silver, silver-coated ETTs could be an effective intervention to prevent VAP in people who require mechanical ventilation for 24 hours or longer.
Our primary objective was to investigate whether silver-coated ETTs are effective in reducing the risk of VAP and hospital mortality in comparison with standard non-coated ETTs in people who require mechanical ventilation for 24 hours or longer. Our secondary objective was to ascertain whether silver-coated ETTs are effective in reducing the following clinical outcomes: device-related adverse events, duration of intubation, length of hospital and intensive care unit (ICU) stay, costs, and time to VAP onset.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014 Issue 10, MEDLINE, EMBASE, EBSCO CINAHL, and reference lists of trials. We contacted corresponding authors for additional information and unpublished studies. We did not impose any restrictions on the basis of date of publication or language. The date of the last search was October 2014.
We included all randomized controlled trials (RCTs) and quasi-randomized trials that evaluated the effects of silver-coated ETTs or a combination of silver with any antimicrobial-coated ETTs with standard non-coated ETTs or with other antimicrobial-coated ETTs in critically ill people who required mechanical ventilation for 24 hours or longer. We also included studies that evaluated the cost-effectiveness of silver-coated ETTs or a combination of silver with any antimicrobial-coated ETTs.
Two review authors (GT, HV) independently extracted the data and summarized study details from all included studies using the specially designed data extraction form. We used standard methodological procedures expected by The Cochrane Collaboration. We performed meta-analysis for outcomes when possible.
We found three eligible randomized controlled trials, with a total of 2081 participants. One of the three included studies did not mention the amount of participants and presented no outcome data. The 'Risk of bias' assessment indicated that there was a high risk of detection bias owing to lack of blinding of outcomes assessors, but we assessed all other domains to be at low risk of bias. Trial design and conduct were generally adequate, with the most common areas of weakness in blinding. The majority of participants were included in centres across North America. The mean age of participants ranged from 61 to 64 years, and the mean duration of intubation was between 3.2 and 7.7 days. One trial comparing silver-coated ETTs versus non-coated ETTs showed a statistically significant decrease in VAP in favour of the silver-coated ETT (1 RCT, 1509 participants; 4.8% versus 7.5%, risk ratio (RR) 0.64, 95% confidence interval (CI) 0.43 to 0.96; number needed to treat for an additional beneficial outcome (NNTB) = 37; low-quality evidence). The risk of VAP within 10 days of intubation was significantly lower with the silver-coated ETTs compared with non-coated ETTs (1 RCT, 1509 participants; 3.5% versus 6.7%, RR 0.51, 95% CI 0.31 to 0.82; NNTB = 32; low-quality evidence). Silver-coated ETT was associated with delayed time to VAP occurrence compared with non-coated ETT (1 RCT, 1509 participants; hazard ratio 0.55, 95% CI 0.37 to 0.84). The confidence intervals for the results of the following outcomes did not exclude potentially important differences with either treatment. There were no statistically significant differences between groups in hospital mortality (1 RCT, 1509 participants; 30.4% versus 26.6%, RR 1.09, 95% CI 0.93 to 1.29; low-quality evidence); device-related adverse events (2 RCTs, 2081 participants; RR 0.65, 95% CI 0.37 to 1.16; low-quality evidence); duration of intubation; and length of hospital and ICU stay. We found no clinical studies evaluating the cost-effectiveness of silver-coated ETTs.
AUTHORS' CONCLUSIONS: This review provides limited evidence that silver-coated ETT reduces the risk of VAP, especially during the first 10 days of mechanical ventilation.
呼吸机相关性肺炎(VAP)是插管及机械通气患者中最常见的医院感染之一。气管内导管(ETT)似乎是VAP的一个独立危险因素。涂银ETT会缓慢释放银阳离子。似乎正是这些银离子具有强大的抗菌作用。由于银的这种抗菌作用,涂银ETT可能是预防需要机械通气24小时或更长时间患者发生VAP的一种有效干预措施。
我们的主要目的是研究与标准未涂银ETT相比,涂银ETT在降低需要机械通气24小时或更长时间患者发生VAP及医院死亡率风险方面是否有效。我们的次要目的是确定涂银ETT在降低以下临床结局方面是否有效:与设备相关的不良事件、插管持续时间、住院时间和重症监护病房(ICU)住院时间、费用以及VAP发病时间。
我们检索了Cochrane对照试验中心注册库(CENTRAL;2014年第10期)、MEDLINE、EMBASE、EBSCO CINAHL以及试验的参考文献列表。我们联系了通讯作者以获取更多信息和未发表的研究。我们没有基于发表日期或语言施加任何限制。最后一次检索日期为2014年10月。
我们纳入了所有评估涂银ETT或银与任何抗菌涂层ETT组合与标准未涂银ETT或其他抗菌涂层ETT相比,对需要机械通气24小时或更长时间的危重症患者影响的随机对照试验(RCT)和半随机试验。我们还纳入了评估涂银ETT或银与任何抗菌涂层ETT组合成本效益的研究。
两位综述作者(GT,HV)使用专门设计的数据提取表独立提取数据,并总结所有纳入研究的详细情况。我们采用了Cochrane协作网期望的标准方法程序。我们尽可能对结局进行荟萃分析。
我们发现三项符合条件的随机对照试验,共2081名参与者。三项纳入研究中的一项未提及参与者数量且未提供结局数据。“偏倚风险”评估表明,由于结局评估者缺乏盲法,存在较高的检测偏倚风险,但我们评估所有其他领域的偏倚风险较低。试验设计和实施总体上是充分的,最常见的薄弱环节在于盲法。大多数参与者来自北美各地的中心。参与者的平均年龄在61至64岁之间,平均插管持续时间在3.2至7.7天之间。一项比较涂银ETT与未涂银ETT的试验显示,涂银ETT组的VAP有统计学显著降低(1项RCT,1509名参与者;4.8%对7.5%,风险比(RR)0.64,95%置信区间(CI)0.43至0.96;为获得额外有益结局所需治疗人数(NNTB)=37;低质量证据)。与未涂银ETT相比,涂银ETT在插管后10天内发生VAP的风险显著更低(1项RCT,1509名参与者;3.5%对6.7%,RR 0.51,95% CI 0.31至0.82;NNTB = 32;低质量证据)。与未涂银ETT相比,涂银ETT与VAP发生时间延迟相关(1项RCT,1509名参与者;风险比0.55,95% CI 0.37至0.84)。以下结局结果的置信区间未排除两种治疗之间潜在的重要差异。两组在医院死亡率(1项RCT,1509名参与者;30.4%对26.6%,RR 1.09,95% CI 0.93至1.29;低质量证据)、与设备相关的不良事件(2项RCT,2081名参与者;RR 0.65,95% CI 0.37至1.16;低质量证据)、插管持续时间、住院时间和ICU住院时间方面无统计学显著差异。我们未发现评估涂银ETT成本效益的临床研究。
本综述提供了有限的证据表明涂银ETT可降低VAP风险,尤其是在机械通气的前10天。