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外周静脉导管插入术的专家与多面手操作者:一项初步随机对照试验

Expert versus generalist inserters for peripheral intravenous catheter insertion: a pilot randomised controlled trial.

作者信息

Marsh Nicole, Webster Joan, Larsen Emily, Genzel Jodie, Cooke Marie, Mihala Gabor, Cadigan Sue, Rickard Claire M

机构信息

Royal Brisbane and Women's Hospital, Herston, QLD, Australia.

School of Nursing and Midwifery, Griffith University, Nathan, QLD, Australia.

出版信息

Trials. 2018 Oct 17;19(1):564. doi: 10.1186/s13063-018-2946-3.

Abstract

BACKGROUND

Peripheral intravenous catheters (PVCs) are essential invasive devices, with 2 billion PVCs sold each year. The comparative efficacy of expert versus generalist inserter models for successful PVC insertion and subsequent reliable vascular access is unknown.

METHODS

A single-centre, parallel-group, pilot randomised controlled trial (RCT) of 138 medical/surgical patients was conducted in a large tertiary hospital in Australia to compare PVC insertion by (1) a vascular access specialist (VAS) or (2) any nursing or medical clinician (generalist model). The primary outcome was the feasibility of a larger RCT as established by predetermined criteria (eligibility, recruitment, retention, protocol adherence). Secondary outcomes were PVC failure: phlebitis, infiltration/extravasation, occlusion, accidental removal or partial dislodgement, local infection or catheter-related bloodstream infection; dwell time; insertion success, insertion attempts; patient satisfaction; and procedural cost-effectiveness.

RESULTS

Feasibility outcomes were achieved: 92% of screened patients were eligible; two patients refused participation; there was no attrition or missing outcome data. PVC failure was higher with generalists (27/50, 54%) than with VASs (33/69, 48%) (228 versus 217 per 1000 PVC days; incidence rate ratio 1.05, 95% confidence interval 0.61-1.80). There were no local or PVC-related infections in either group. All PVCs (n = 69) were successfully inserted in the VAS group. In the generalist group, 19 (28%) patients did not have a PVC inserted. There were inadequate data available for the cost-effectiveness analysis, but the mean insertion procedure time was 2 min in the VAS group and 11 min in the generalist group. Overall satisfaction with the PVC was measured on an 11-point scale (0 = not satisfied and 10 = satisfied) and was higher in the VAS group (n = 43; median = 7) compared to the generalist group (n = 20; median = 4.5). The multivariable model identified medical diagnosis and bed-bound status as being significantly associated with higher PVC failure, and securement with additional non-sterile tape was significantly associated with lower PVC failure.

CONCLUSION

This pilot trial confirmed the feasibility and need for a large, multicentre RCT to test these PVC insertion models.

TRIAL REGISTRATION

Australian New Zealand Clinical Trials Registry, ACTRN12616001675415 . Registered on 6 December 2016.

摘要

背景

外周静脉导管(PVC)是重要的侵入性器械,每年销售量达20亿根。专家型与普通型置管者模型在成功置入PVC及随后获得可靠血管通路方面的比较疗效尚不清楚。

方法

在澳大利亚一家大型三级医院对138例内科/外科患者进行了一项单中心、平行组、先导随机对照试验(RCT),以比较由(1)血管通路专家(VAS)或(2)任何护理或医疗临床医生(普通型模型)进行的PVC置入情况。主要结局是根据预定标准(合格性、招募、保留、方案依从性)确定的更大规模RCT的可行性。次要结局包括PVC失败:静脉炎、渗漏/外渗、堵塞、意外拔除或部分移位、局部感染或导管相关血流感染;留置时间;置入成功情况、置入尝试次数;患者满意度;以及操作成本效益。

结果

实现了可行性结局:92%的筛查患者合格;2例患者拒绝参与;无失访或结局数据缺失。普通型置管者的PVC失败率(27/50,54%)高于VAS(33/69,48%)(每1000个PVC日分别为228次与217次;发病率比值1.05,95%置信区间0.61 - 1.80)。两组均无局部或与PVC相关的感染。VAS组所有PVC(n = 69)均成功置入。在普通型置管者组,19例(28%)患者未成功置入PVC。成本效益分析的数据不足,但VAS组平均置入操作时间为2分钟,普通型置管者组为11分钟。对PVC的总体满意度采用11分制(0 = 不满意,10 = 满意)进行测量,VAS组(n = 43;中位数 = 7)高于普通型置管者组(n = 20;中位数 = 4.5)。多变量模型确定医学诊断和卧床状态与较高的PVC失败显著相关,使用额外的非无菌胶带固定与较低的PVC失败显著相关。

结论

这项先导试验证实了进行一项大型多中心RCT来测试这些PVC置入模型的可行性和必要性。

试验注册

澳大利亚新西兰临床试验注册中心,ACTRN12616001675415。于2016年12月6日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c284/6192347/03f0e222a711/13063_2018_2946_Fig1_HTML.jpg

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