Kleidon Tricia M, Keogh Samantha, Flynn Julie, Schults Jessica, Mihala Gabor, Rickard Claire M
Department of Anaesthetics, Queensland Children's Hospital, Brisbane, Queensland, Australia.
Alliance for Vascular Access Teaching and Research (AVATAR), Menzies Heath Institute Queensland, Griffith University, Brisbane, Queensland, Australia.
J Paediatr Child Health. 2020 Jan;56(1):22-29. doi: 10.1111/jpc.14482. Epub 2019 Apr 29.
To test the feasibility of an efficacy trial comparing different flushing frequencies and volumes to reduce peripheral intravenous cannula (PIVC) failure in paediatric inpatients.
Pilot, 2 × 2 factorial, randomised controlled trial comparing PIVC flushing techniques in intervention pairs: (i) low volume (3 mL) versus high volume (10 mL); and (ii) low frequency (24 hourly) versus high frequency (6 hourly). Patients were excluded if: fluids were restricted, weight < 5 kg, PIVC already in situ for >24 h or continuous infusion. The primary end-point was feasibility (eligibility, recruitment, retention, protocol adherence, missing data and sample size estimates) of a large trial. Secondary end-points were PIVC failure (composite and individual), bloodstream infection and mortality.
A total of 919 children were screened from April to November 2015, with 55 enrolled. Screening feasibility criteria were not met, mainly due to continuous infusions and PIVCs in situ >24 h or planned for imminent removal. However, 80% of eligible participants consented, 2% withdrew, protocol adherence was 100%, and there was no missing primary end-point data. PIVC failure was significantly higher (hazard ratio = 2.90, 95% confidence interval: 1.11-7.54) in the 3 mL compared to the 10 mL group. There was no difference in failure between frequency groups (hazard ratio = 0.91, 95% confidence interval: 0.36-2.33). There was no interaction effect (P = 0.22).
Trial feasibility proved challenging due to eligibility criteria, which could be improved with additional recruiting staff. Firm conclusions cannot be made based on this small sample, but flush volume may impact PIVC failure.
测试一项疗效试验的可行性,该试验旨在比较不同的冲管频率和容量,以降低儿科住院患者外周静脉留置针(PIVC)失败的发生率。
进行先导性、2×2析因随机对照试验,比较干预组中PIVC的冲管技术:(i)小容量(3毫升)与大容量(10毫升);以及(ii)低频(每24小时一次)与高频(每6小时一次)。如果患者存在以下情况则被排除:液体摄入受限、体重<5千克、PIVC已在位超过24小时或正在进行持续输注。主要终点是大型试验的可行性(合格性、招募、留存率、方案依从性、缺失数据和样本量估计)。次要终点是PIVC失败(综合和个体)、血流感染和死亡率。
2015年4月至11月共筛查了919名儿童,55名入组。未达到筛查可行性标准,主要原因是持续输注以及PIVC在位超过24小时或计划即将拔除。然而,80%的合格参与者同意参与,2%退出,方案依从性为100%,且没有缺失主要终点数据。与10毫升组相比,3毫升组的PIVC失败率显著更高(风险比=2.90,95%置信区间:1.11-7.54)。频率组之间的失败率没有差异(风险比=0.91,95%置信区间:0.36-2.33)。没有交互作用(P=0.22)。
由于合格标准,试验可行性证明具有挑战性,增加招募人员可能会有所改善。基于这个小样本无法得出确凿结论,但冲管容量可能会影响PIVC失败率。