背景:用于呼吸道疾病患儿抗生素给药的最佳静脉装置尚不确定。我们评估了一项随机对照试验的可行性,该试验比较了中线导管与经外周插入的中央导管。
方法:前瞻性,双臂,澳大利亚第三大学的可行性随机对照试验,儿科医院。随机分配110名儿童(<18岁)接受(i)中线导管和(ii)外周插入中心导管。主要结果是可行性(合格,招募,保留,遵守协议,和可接受性),主要临床结局是静脉导管插入的全身麻醉需求。
结果:插入时间,治疗延误,输液效率,设备故障,并发症,和成本。
结果:有80%的招聘,100%保留,没有丢失的数据,和高的患者/工作人员可接受性。在0-10数字评定量表上评估的平均患者体验为8.0外周插入中心导管和9.0(中线导管),分别。未达到参与者资格(49%的筛查患者),并且各组之间的方案依从性中等(89%的外周插入中心导管与76%的中线导管)。与外周插入中心导管相比,插入中线导管进行肺部优化可降低全身麻醉的需求(10%vs.69%;比值比=0.01,95%置信区间:0.00-0.09)。中线导管失效的频率更高(18.1vs.每1000个导管天5.5个外周中心导管);然而,这在试验期间减少。与经外周插入的中央导管相比,中线导管插入每次肺部优化发作可节省AUD$1451。
结论:在引入新设备时,通过扩大资格标准和强化员工培训,有效性试验是可行的。患者和工作人员可接受外周相容性输液的中线导管。可能会否定全身麻醉的需要,并导致显著的成本节约。
BACKGROUND: The optimal intravenous device for antibiotic administration for children with respiratory disease is uncertain. We assessed the feasibility of a randomized controlled
trial comparing
midline catheters with peripherally inserted central catheters.
METHODS: Prospective, two-arm, feasibility randomized controlled
trial in an Australian tertiary, pediatric hospital. Random assignment of 110 children (<18 years) to receive (i) midline catheter and (ii) peripherally inserted central catheters. Primary outcome was feasibility (eligibility, recruitment, retention, protocol adherence, and acceptability), and the primary clinical outcome was general anesthesia requirement for intravenous catheter insertion.
RESULTS: insertion time, treatment delays, infusion efficiency, device failure, complications, and cost.
RESULTS: There was 80% recruitment, 100% retention, no missing data, and high patient/staff acceptability. Mean patient experience assessed on a 0-10 numeric rating scale was 8.0 peripherally inserted central catheters and 9.0 (midline catheters), respectively. Participant eligibility was not achieved (49% of screened patients) and moderate protocol-adherence across groups (89% peripherally inserted central catheters vs. 76% midline catheter). Insertion of
midline catheter for pulmonary optimization reduced the requirement for general anesthesia compared to peripherally inserted central catheters (10% vs. 69%; odds ratio = 0.01, 95% confidence interval: 0.00-0.09). Midline catheters failed more frequently (18.1 vs. 5.5 peripherally inserted central catheters per 1000 catheter-days); however, this reduced over
trial duration. Midline catheter insertion compared to peripherally inserted central catheters saved AUD$1451 per pulmonary optimization episode.
CONCLUSIONS: An efficacy
trial is feasible with expanded eligibility criteria and intensive staff training when introducing a new device. Midline catheter for peripherally compatible infusions is acceptable to patients and staff, might negate the need for general anesthesia and results in significant cost savings.