背景:外周插入的中央导管(PICC)有助于医疗保健中的诊断和治疗干预。PICC可能由于感染性和非感染性并发症而失败,PICC材料和设计可能有助于,导致患者和医疗系统的负面后遗症。
目的:评估PICC材料和设计在减少导管失效和并发症方面的有效性。
方法:昆士兰大学和Cochrane血管信息专家搜索了Cochrane血管专业注册,中部,MEDLINE,Embase,和CINAHL数据库以及WHOICTRP和ClinicalTrials.gov试验注册至2023年5月16日。我们旨在通过搜索检索到的纳入试验的参考列表来确定其他可能符合条件的试验或辅助出版物。以及相关的系统评价,荟萃分析,和卫生技术评估报告。我们联系了该领域的专家,以确定其他相关信息。
方法:我们纳入了评价PICC设计和材料的随机对照试验(RCT)。
方法:我们使用标准Cochrane方法。我们的主要结果是静脉血栓栓塞(VTE),PICC相关血流感染(BSI),遮挡,和全因死亡率。次要结果为导管失效,与PICC相关的BSI,导管断裂,PICC停留时间,和安全端点。我们使用GRADE评估了证据的确定性。
结果:我们纳入了12项RCT,涉及约2913名参与者(一项多臂研究)。除一项研究外,所有研究在一个或多个偏倚风险领域都有较高的偏倚风险。与无瓣膜技术相比,集成瓣膜技术与无瓣膜技术相比,与无瓣膜的PICC相比,集成瓣膜技术对VTE风险的影响很小或没有差异(风险比(RR)0.71,95%置信区间(CI)0.19至2.63;I²=0%;3项研究;437名参与者;低确定性证据)。我们不确定集成阀门技术是否降低了与PICC相关的BSI风险,证据的确定性非常低(RR0.20,95%CI0.01~4.00;I²=不适用;2项研究(1项研究中无事件);257名参与者).与无瓣膜的PICC相比,集成瓣膜技术可能对闭塞风险影响很小或没有影响(RR0.86,95%CI0.53至1.38;I²=0%;5项研究;900名参与者;低确定性证据)。我们不确定使用集成阀门技术是否降低了全因死亡风险,因为证据的确定性非常低(RR0.85,95%CI0.44~1.64;I²=0%;2项研究;473名参与者)。与无瓣膜的PICC相比,集成瓣膜技术对导管失效风险影响很小或没有影响(RR0.80,95%CI0.62至1.03;I²=0%;4项研究;720名参与者;低确定性证据)。我们不确定集成瓣膜技术是否降低了与PICC相关的BSI风险(RR0.51,95%CI0.19至1.32;I²=不适用;2项研究(1项研究中无事件);542名参与者)或导管断裂,因为证据的确定性非常低(RR1.05,95%CI0.22~5.06;I²=20%;4项研究;799名参与者).我们不确定使用抗血栓形成表面修饰的导管是否可降低VTE风险(RR0.67,95%CI0.13至3.54;I²=15%;2项研究;257名参与者)或PICC相关BSI,因为证据的确定性非常低(RR0.20,95%CI0.01~4.00;I²=不适用;2项研究(1项研究无事件);257名参与者).我们不确定使用抗血栓形成表面修饰导管是否能减少闭塞(RR0.69,95%CI0.04-11.22;I²=70%;2项研究;257名参与者)或全因死亡风险,因为证据的确定性非常低(RR0.49,95%CI0.05至5.26;I²=不适用;1项研究;111名参与者)。使用抗血栓形成表面改性导管可能对导管失效风险影响很小或没有影响(RR0.76,95%CI0.37至1.54;I²=46%;2项研究;257名参与者;低确定性证据)。在一项研究中没有PICC相关BSI的报道(111名参与者)。因此,我们不确定使用抗血栓形成表面修饰导管是否能降低PICC相关BSI风险(RR不可估计;I²=不适用;确定性证据非常低).我们不确定使用抗血栓形成表面改性导管是否能降低导管断裂的风险。证据的确定性非常低(RR0.15,95%CI0.01~2.79;I²=不适用;2项研究(1项研究中无事件);257名参与者).我们不确定抗菌浸渍导管的使用是否能降低VTE风险(RR0.54,95%CI0.05至5.88;I²=不适用;1项研究;167名参与者)或PICC相关的BSI风险,因为证据的确定性非常低(RR2.17,95%CI0.20至23.53;I²=不适用;1项研究;167名参与者)。抗菌药物浸渍导管可能对闭塞风险影响很小或没有影响(RR1.00,95%CI0.57至1.74;I²=0%;2项研究;1025名参与者;中度确定性证据)或全因死亡率(RR1.12,95%CI0.71至1.75;I²=0%;2项研究;1082名参与者;中度确定性证据)。浸渍抗菌药物的导管可能对导管失效风险影响很小或没有影响(RR1.04,95%CI0.82至1.30;I²=不适用;1项研究;221名参与者;低确定性证据)。抗菌药物浸渍的导管可能对PICC相关的BSI风险影响很小或没有影响(RR1.05,95%CI0.71至1.55;I²=不适用;2项研究(1项研究中无事件);1082名参与者;中度确定性证据)。浸渍抗菌药物的导管可能对导管断裂的风险影响很小或没有影响(RR0.86,95%CI0.19至3.83;I²=不适用;1项研究;804名参与者;低确定性证据)。
结论:可用于指导临床医生对PICC材料和设计决策的高质量RCT证据有限。当前证据的局限性包括样本量小,罕见事件,和偏见的风险。静脉血栓栓塞的风险可能几乎没有差异,PICC相关BSI,遮挡,或PICC材料和设计的死亡率。需要进一步严格的RCT来减少不确定性。
BACKGROUND: Peripherally inserted central catheters (PICCs) facilitate diagnostic and therapeutic interventions in health care. PICCs can fail due to infective and non-infective complications, which PICC materials and design may contribute to, leading to negative sequelae for patients and healthcare systems.
OBJECTIVE: To assess the effectiveness of PICC material and design in reducing catheter failure and complications.
METHODS: The University of Queensland and Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the WHO ICTRP and ClinicalTrials.gov trials registers to 16 May 2023. We aimed to identify other potentially eligible trials or ancillary publications by searching the reference lists of retrieved included trials, as well as relevant systematic reviews, meta-analyses, and health technology assessment reports. We contacted experts in the field to ascertain additional relevant information.
METHODS: We included randomised controlled trials (RCTs) evaluating PICC design and materials.
METHODS: We used standard Cochrane methods. Our primary outcomes were venous thromboembolism (VTE), PICC-associated bloodstream infection (BSI), occlusion, and all-cause mortality. Secondary outcomes were catheter failure, PICC-related BSI, catheter breakage, PICC dwell time, and safety endpoints. We assessed the certainty of evidence using GRADE.
RESULTS: We included 12 RCTs involving approximately 2913 participants (one multi-arm study). All studies except one had a high risk of bias in one or more risk of bias domain. Integrated valve technology compared to no valve technology for peripherally inserted central catheter design Integrated valve technology may make little or no difference to VTE risk when compared with PICCs with no valve (risk ratio (RR) 0.71, 95% confidence interval (CI) 0.19 to 2.63; I² = 0%; 3 studies; 437 participants; low certainty evidence). We are uncertain whether integrated valve technology reduces PICC-associated BSI risk, as the certainty of the evidence is very low (RR 0.20, 95% CI 0.01 to 4.00; I² = not applicable; 2 studies (no events in 1 study); 257 participants). Integrated valve technology may make little or no difference to occlusion risk when compared with PICCs with no valve (RR 0.86, 95% CI 0.53 to 1.38; I² = 0%; 5 studies; 900 participants; low certainty evidence). We are uncertain whether use of integrated valve technology reduces all-cause mortality risk, as the certainty of evidence is very low (RR 0.85, 95% CI 0.44 to 1.64; I² = 0%; 2 studies; 473 participants). Integrated valve technology may make little or no difference to catheter failure risk when compared with PICCs with no valve (RR 0.80, 95% CI 0.62 to 1.03; I² = 0%; 4 studies; 720 participants; low certainty evidence). We are uncertain whether integrated-valve technology reduces PICC-related BSI risk (RR 0.51, 95% CI 0.19 to 1.32; I² = not applicable; 2 studies (no events in 1 study); 542 participants) or catheter breakage, as the certainty of evidence is very low (RR 1.05, 95% CI 0.22 to 5.06; I² = 20%; 4 studies; 799 participants). Anti-thrombogenic surface modification compared to no anti-thrombogenic surface modification for peripherally inserted central catheter design We are uncertain whether use of anti-thrombogenic surface modified catheters reduces risk of VTE (RR 0.67, 95% CI 0.13 to 3.54; I² = 15%; 2 studies; 257 participants) or PICC-associated BSI, as the certainty of evidence is very low (RR 0.20, 95% CI 0.01 to 4.00; I² = not applicable; 2 studies (no events in 1 study); 257 participants). We are uncertain whether use of anti-thrombogenic surface modified catheters reduces occlusion (RR 0.69, 95% CI 0.04 to 11.22; I² = 70%; 2 studies; 257 participants) or all-cause mortality risk, as the certainty of evidence is very low (RR 0.49, 95% CI 0.05 to 5.26; I² = not applicable; 1 study; 111 participants). Use of anti-thrombogenic surface modified catheters may make little or no difference to risk of catheter failure (RR 0.76, 95% CI 0.37 to 1.54; I² = 46%; 2 studies; 257 participants; low certainty evidence). No PICC-related BSIs were reported in one study (111 participants). As such, we are uncertain whether use of anti-thrombogenic surface modified catheters reduces PICC-related BSI risk (RR not estimable; I² = not applicable; very low certainty evidence). We are uncertain whether use of anti-thrombogenic surface modified catheters reduces the risk of catheter breakage, as the certainty of evidence is very low (RR 0.15, 95% CI 0.01 to 2.79; I² = not applicable; 2 studies (no events in 1 study); 257 participants). Antimicrobial impregnation compared to non-antimicrobial impregnation for peripherally inserted central catheter design We are uncertain whether use of antimicrobial-impregnated catheters reduces VTE risk (RR 0.54, 95% CI 0.05 to 5.88; I² = not applicable; 1 study; 167 participants) or PICC-associated BSI risk, as the certainty of evidence is very low (RR 2.17, 95% CI 0.20 to 23.53; I² = not applicable; 1 study; 167 participants). Antimicrobial-impregnated catheters probably make little or no difference to occlusion risk (RR 1.00, 95% CI 0.57 to 1.74; I² = 0%; 2 studies; 1025 participants; moderate certainty evidence) or all-cause mortality (RR 1.12, 95% CI 0.71 to 1.75; I² = 0%; 2 studies; 1082 participants; moderate certainty evidence). Antimicrobial-impregnated catheters may make little or no difference to risk of catheter failure (RR 1.04, 95% CI 0.82 to 1.30; I² = not applicable; 1 study; 221 participants; low certainty evidence). Antimicrobial-impregnated catheters probably make little or no difference to PICC-related BSI risk (RR 1.05, 95% CI 0.71 to 1.55; I² = not applicable; 2 studies (no events in 1 study); 1082 participants; moderate certainty evidence). Antimicrobial-impregnated catheters may make little or no difference to risk of catheter breakage (RR 0.86, 95% CI 0.19 to 3.83; I² = not applicable; 1 study; 804 participants; low certainty evidence).
CONCLUSIONS: There is limited high-quality RCT evidence available to inform clinician decision-making for PICC materials and design. Limitations of the current evidence include small sample sizes, infrequent events, and risk of bias. There may be little to no difference in the risk of VTE, PICC-associated BSI, occlusion, or mortality across PICC materials and designs. Further rigorous RCTs are needed to reduce uncertainty.