Faculty of Medicine, Lund University, Lund, Sweden
Department of Intensive and Perioperative Care, Skåne University Hospital Lund, Lund, Skåne, Sweden.
BMJ Open. 2023 Dec 19;13(12):e080515. doi: 10.1136/bmjopen-2023-080515.
Central venous catheters are indispensable in modern healthcare. Unfortunately, they are accompanied by minor as well as major complications, leading to increased morbidity, mortality and costs. Immediate insertion-related complications (mechanical complications) have decreased due to the implementation of real-time ultrasound guidance, but they still occur and additional efforts to enhance patient safety are warranted. This study aims to investigate whether the use of a needle guide mounted on the ultrasound probe in subclavian catheterisations may decrease the number of catheterisations with >1 skin puncture (primary outcome).
This is an investigator-initiated, non-commercial, randomised, controlled, parallel-group study conducted at Skåne University Hospital, Lund, Sweden. Adults (≥18 years) with a clinical indication for a subclavian central venous catheter and the ability to give written informed consent will be eligible for inclusion. Exclusion criteria include subclavian catheterisation deemed unsuitable based on the preprocedural ultrasound examination. Patients will be randomised to catheterisation by certified operators using a microconvex probe (long-axis, in-plane technique) with (n=150) or without (n=150) a needle guide. The ultrasound imaging from the procedures will be recorded and assessed by two reviewers individually. The assessors will be blinded for group affiliation. Secondary outcomes include the total number of skin punctures, mechanical complications, time to successful venous puncture, number of failed catheterisations and operator satisfaction with the needle guide at the end of the study period.Recruitment started on 8 November 2022 and will continue until the sample size is achieved.
This study was approved by the Swedish Ethical Review Authority (#2022-04073-01) and the Swedish Medical Products Agency (#5.1-2022-52130; CIV-21-12-038367). The findings will be submitted to an international peer-reviewed journal.
NCT05513378, clinicaltrials.gov.
中心静脉导管在现代医疗保健中不可或缺。然而，它们会伴随轻微和严重的并发症，导致发病率、死亡率和成本增加。实时超声引导的应用已经减少了立即发生的与插入相关的并发症（机械性并发症），但它们仍然存在，需要进一步努力提高患者安全性。本研究旨在调查在锁骨下置管时使用安装在超声探头上的针引导装置是否可以减少需要>1 次皮肤穿刺的置管数量（主要结局）。
这是一项由研究者发起的、非商业性的、随机对照、平行组研究，在瑞典隆德的斯科讷大学医院进行。有临床指征需要锁骨下中心静脉导管且能够书面知情同意的成年人（≥18 岁）将有资格入组。排除标准包括根据术前超声检查认为锁骨下置管不适合的患者。患者将由经过认证的操作者使用微凸探头（长轴、平面内技术）进行随机分组，一组（n=150）使用针引导装置，另一组（n=150）不使用。将记录程序的超声图像，并由两名审阅者分别进行评估。评估者将对分组归属保持盲态。次要结局包括总皮肤穿刺次数、机械性并发症、成功静脉穿刺的时间、置管失败的次数以及研究结束时操作者对针引导装置的满意度。招募于 2022 年 11 月 8 日开始，将持续到达到样本量。
本研究已获得瑞典伦理审查局（#2022-04073-01）和瑞典药品管理局（#5.1-2022-52130；CIV-21-12-038367）的批准。研究结果将提交给国际同行评议期刊。
NCT05513378，clinicaltrials.gov。
