Multiple lumen umbilical venous catheters (ML-UVCs) instead of single lumen UVCs (SL-UVCs) may decrease the need for additional venous lines. Although it seems self-evident that ML-UVCs would reduce the need of additional venous lines, the rates of associated complications might be different.
To compare the effectiveness and the safety of ML-UVCs versus SL-UVCs in terms of need of additional vascular access, rates of complications, morbidity and mortality in newborn infants.
Randomized and quasi-randomized trials were identified by searching the MEDLINE (1966 - February 2005), EMBASE (1980- February 2005), CINAHL (1982 - February 2005), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 4, 2004) and Science Direct (subject area: medicine, journal and abstract database; 1967 to February 2005). Literature search also included a manual search of the abstracts of scientific meetings published in Pediatric Research (1990-2004). Additional citations were sought using references in articles retrieved from searches. Subject experts were contacted to identify the unpublished and ongoing studies.
Randomized and quasi-randomized controlled clinical trials comparing safety and efficacy of multiple versus single lumen umbilical venous catheter in neonates (both term and preterm) who were in need of umbilical venous catheter insertion for vascular access in first four weeks of life.
Data collection and analysis
Each review author performed data extraction independently and differences were resolved by discussion. The following outcomes were determined: total number of additional peripheral intravenous lines per baby in first week and first four weeks of life, total number of additional percutaneously and surgically placed central venous lines per baby in first four weeks of life, and other safety and efficacy measures. The treatment effect estimators used were RR, RD, and WMD when appropriate along with their 95% CI. If RD was statistically significant, then number needed to treat (NNT) or number needed to harm (NNH) was calculated.
Three studies qualified for inclusion in this review (Khilnani 1991; Loisel 1996; Soupre 1998). There was a decrease in the ML-UVCs group in the number of additional PIVs used in the first week of life [WMD -1.42, (95% CI -1.74, -1.10), p<0.00001, number of infants (n) = 99]. There was no significant effect on the number of additional PIVs used in the first four weeks of life [MD -2.30, (95% CI -6.65, 2.05), n=36]. There was an increase in catheter malfunction in the ML-UVCs group [typical RR 3.69 (95% CI 0.99, 13.81), p=0.05; RD 0.15 (95% CI 0.03, 0.27), p=0.01; NNH was 7, 95% CI 4, 33; n=99]. The following outcomes were not significantly different in the two groups: clinical sepsis, catheter related blood stream infection, catheter-associated thrombosis, complications related to catheter malposition in heart and great vessels, NEC and early neonatal mortality.
The use of ML-UVCs in comparison to SL-UVCs in neonates is associated with decrease in the usage of PIVs in first week of life, but an increase in catheter malfunctions. As the quality of included randomized studies is poor and the estimates of clinically important complications are imprecise, no firm recommendations can be made regarding the choice of UVC. Adequately powered, properly randomized and properly blinded controlled trials are needed that address the effectiveness and safety of ML-UVCs (double and triple lumen) in comparison to SL-UVCs. These studies should also address the impact of type of catheter material.
用多管腔臍靜脈導管 (MLUVCs) 取代單一管腔臍靜脈導管 (SLUVCs) 可能可以減少額外靜脈管路的需求。雖然多管腔臍靜脈導管減少額外靜脈管路的需求，但是它引起相關併發症的比率卻可能不同。
搜尋MEDLINE (1966 February 2005) ， EMBASE (1980February 2005) ，CINAHL (1982 February 2005) ，the Cochrane Central Register of Controlled Trials (CENTRAL，The Cochrane Library，Issue 4, 2004) and Science Direct (subject area： medicine， journal and abstract database；1967 to February 2005) 等資料庫可以找到一些隨機與近似隨機的臨床試驗。文獻搜尋也包括人工搜尋到一些刊登在Pediatric Research (1990 – 2004) 上的科學性會議的摘要。其他引用的文章是從搜尋到文章的參考文獻中找出。相關主題的專家也會被詢問以找出一些未發表的文章或是正在進行中的研究。
隨機與近似隨機控制臨床試驗文獻將新生兒 (包括足月兒和早產兒) 使用多管腔臍靜脈導管與單一管腔臍靜脈導管的效果與安全性做一個比較。而這些新生兒都是需要在出生四週內給予臍靜脈導管放置作為血管途徑的。
每個回顧文獻的作者將蒐集的數據獨立選出，差異性以討論的方式解決。然後得到以下的結果: 在出生第一週內及前四週每個新生兒額外接受周邊靜脈導管放置的次數，出生前四週內每個新生兒額外接受經皮或手術放置中央靜脈導管的次數，和其他關於效度和安全度的測量。治療效果的評量指標包括RR，RD，WMD，適當時加上95% CI. 如果RD在統計上有意義，number needed to treat (NNT) 或number needed to harm (NNH) 才會被計算。
有三篇研究包含在這篇回顧的文獻 (Khilnani 1991; Loisel 1996; Soupre 1998) 。多管腔臍靜脈導管組在出生第一週內額外接受周邊靜脈導管放置的次數較為減少 [WMD −1.42， (95% CI −1.74, −1.10) ，p<0.00001， number of infants (n) = 99] ，然而在出生前四週內額外接受周邊靜脈導管放置的次數則沒有差別 [MD −2.30， (95% CI −6.65， 2.05) ， n = 36] 。多管腔臍靜脈導管組發生管路功能不良的情形較為增加 [typical RR 3.69 (95% CI 0.99，13.81) ，p = 0.05; RD 0.15 (95% CI 0.03，0.27) ， p = 0.01: NNH was 7, 95% CI 4, 33; n = 99] 。以下的結果在兩組之間並沒有顯著差異性：臨床上的敗血症，導管相關的血液感染，導管相關的血栓，導管在心臟或大血管中的位置不良導致的併發症，壞死性腸炎，新生兒早期死亡。
多管腔臍靜脈導管的使用相對於單一管腔臍靜脈導管可減少出生第一週內額外接受周邊靜脈導管放置的次數，但容易發生管路功能不良的情形。因為所包含的隨機研究品質不良，臨床上重要的併發症評估不準確，使得臍靜脈導管的選擇建議無法確定。多管腔臍靜脈導管 (雙管腔或三管腔) 相對於單一管腔臍靜脈導管的效度和安全性，需要有適當強度且隨機，控制良好的臨床試驗來評估。而這些研究也應該評估導管材質造成的影響。
此翻譯計畫由臺灣國家衛生研究院 (National Health Research Institutes, Taiwan) 統籌。