当前位置: X-MOL 学术Eur. Respir. J. › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
A randomised controlled trial of intrapleural balloon intercostal chest drains to prevent drain displacement
European Respiratory Journal ( IF 16.6 ) Pub Date : 2022-07-21 , DOI: 10.1183/13993003.01753-2021
Rachel M Mercer 1, 2 , Eleanor Mishra 3 , Radhika Banka 2, 3 , John P Corcoran 4 , Cyrus Daneshvar 4 , Rakesh K Panchal 5 , Tarek Saba 6 , Melanie Caswell 6 , Sarah Johnstone 5 , Daniel Menzies 7 , Sana Ahmer 7 , Mitra Shahidi 8 , Amelia O Clive 9 , Manish Gautam 10 , Giles Cox 11 , Chris Orton 12 , Judith Lyons 13 , Nadeem Maddekar 14 , Duneesha De Fonseka 15 , Kathryn Prior 16 , Simon Barnes 17 , Grace Robinson 18 , Louise Brown 19 , Mohammed Munavvar 20 , Palav L Shah 12, 21 , Robert J Hallifax 1, 2 , Kevin G Blyth 22 , Emma Hedley 1, 2 , Nick A Maskell 9 , Stephen Gerry 23 , Robert F Miller 24 , Najib M Rahman 2, 25, 26, 27 , Samuel V Kemp 12, 21, 27
Affiliation  

Background

Chest drain displacement is a common clinical problem that occurs in 9–42% of cases and results in treatment failure or additional pleural procedures conferring unnecessary risk. A novel chest drain with an integrated intrapleural balloon may reduce the risk of displacement.

Methods

A prospective randomised controlled trial comparing the balloon drain to standard care (12 F chest drain with no balloon) with the primary outcome of objectively defined unintentional or accidental chest drain displacement.

Results

267 patients were randomised (primary outcome data available in 257, 96.2%). Displacement occurred less frequently using the balloon drain (displacement 5 of 128, 3.9%; standard care displacement 13 of 129, 10.1%) but this was not statistically significant (OR for drain displacement 0.36, 95% CI 0.13–1.0, Chi-squared 1 degree of freedom (df)=2.87, p=0.09). Adjusted analysis to account for minimisation factors and use of drain sutures demonstrated balloon drains were independently associated with reduced drain fall-out rate (adjusted OR 0.27, 95% CI 0.08–0.87, p=0.028). Adverse events were higher in the balloon arm than the standard care arm (balloon drain 59 of 131, 45.0%; standard care 18 of 132, 13.6%; Chi-squared 1 df=31.3, p<0.0001).

Conclusion

Balloon drains reduce displacement compared with standard drains independent of the use of sutures but are associated with increased adverse events specifically during drain removal. The potential benefits of the novel drain should be weighed against the risks, but may be considered in practices where sutures are not routinely used.



中文翻译:

胸膜内球囊肋间胸腔引流防止引流移位的随机对照试验

背景

胸腔引流管移位是一个常见的临床问题,发生在 9-42% 的病例中,并导致治疗失败或额外的胸膜手术带来不必要的风险。带有集成胸膜内球囊的新型胸腔引流管可以降低移位的风险。

方法

一项前瞻性随机对照试验,将球囊引流与标准护理(无球囊的 12 F 胸腔引流管)与客观定义的无意或意外胸腔引流管移位的主要结果进行比较。

结果

267 名患者被随机分组​​(主要结果数据为 257,96.2%)。使用球囊引流管发生移位的频率较低(128 例中的第 5 次移位,3.9%;129 例中的第 13 次移位,10.1%)但这没有统计学意义(引流管移位的 OR 为 0.36,95% CI 0.13-1.0,卡方1 自由度 (df)=2.87, p=0.09)。考虑到最小化因素和使用引流缝合线的调整分析表明,球囊引流与引流脱落率降低独立相关(调整后的 OR 0.27, 95% CI 0.08-0.87, p=0.028)。球囊组的不良事件高于标准治疗组(131 例中的 59 例球囊引流,45.0%;标准治疗 132 例中的 18 例,13.6%;卡方 1 df=31.3,p<0.0001)。

结论

与不使用缝合线的标准引流相比,气囊引流减少了位移,但与特别是在引流移除期间的不良事件增加有关。应权衡新型引流管的潜在益处与风险,但在不常规使用缝合线的实践中可以考虑。

更新日期:2022-07-21
down
wechat
bug