Department of Anaesthesia and Intensive Care, Slovak Medical University, F. D. Roosevelt University Hospital, Banska Bystrica, Slovakia.
Department of Biology & Ecology, Faculty of Natural Sciences, Matej Bel University, Banska Bystrica, Slovakia.
Trials. 2023 Jul 21;24(1):467. doi: 10.1186/s13063-023-07459-x.
More than 2 billion peripheral vascular cannulas are introduced globally each year. It is the most frequently performed invasive procedure in medicine worldwide. There is a group of patients with difficult intravenous access (DIVA). In experts' hands, ultrasound-guided vascular access appears to be a significantly better method. Investigators hypothesize that UGVA is superior also in short-term patency of cannula and even for blood draw through cannula. Repeated cannula pricks in the operating room setting not only puts a lot of stress on the patient and medical staff, but they also waste OR time.
This investigator-initiated prospective randomized monocentric controlled trial is designed to randomly allocate 200 patients undergoing elective primary total joint arthroplasty of hip or knee to one of two groups as follows: Group C (control group) - peripheral venous cannula insertion by palpation or Group USG (intervention) - cannula insertion by ultrasound-guided vascular access. Our primary endpoint is to compare the number of attempts for ultrasound-guided insertion of the peripheral venous cannula with common palpation insertion of the peripheral venous cannula in overweight/obese patients (BMI ≥ 25). The secondary endpoint is a failure rate of the peripheral venous cannula to administer intravenous therapy up to 5 days postoperatively. Tertiary endpoints include a portion of long PVCs that are able to ensure blood draw up to 5 days postoperatively, time needed to insert PVC in each group, number of needle tip redirections in both groups, and reinsertion of PVC needed in both groups for any reason.
This study is pragmatic and is looking for clinically relevant data. After completion, it will answer the question of whether it is clinically relevant to use ultrasound-guided vascular access in the context of not only short-term benefit of insertion, but also up to 5 days after insertion. Also, if this method can ensure blood draw through a peripheral vein cannula, it can save resources in the perioperative period - valuable especially considering the ongoing shortage of medical staff worldwide. If this hypothesis is confirmed, this finding could contribute to more widespread implementation of ultrasound-guided peripheral vascular access in the perioperative period.
ClinicalTrials.gov NCT05156008. Registered on 13.12.2021.
全球每年有超过 20 亿根外周血管导管被引入。这是全球范围内最常进行的有创操作。有一组患者静脉穿刺困难（DIVA）。在专家手中，超声引导下的血管通路似乎是一种明显更好的方法。研究人员假设 UGVA 不仅在导管的短期通畅性方面，甚至在通过导管采血方面也具有优势。在手术室环境中反复进行导管穿刺不仅给患者和医务人员带来很大压力，而且还浪费手术室时间。
这项由研究者发起的前瞻性随机单中心对照试验旨在将 200 名接受择期初次全髋关节或膝关节置换术的患者随机分配到以下两组之一：C 组（对照组）- 通过触诊插入外周静脉导管或 USG 组（干预组）- 通过超声引导血管通路插入导管。我们的主要终点是比较超声引导下插入外周静脉导管与超重/肥胖患者（BMI≥25）常规触诊插入外周静脉导管的尝试次数。次要终点是术后 5 天内静脉治疗失败率。次要终点包括能够保证术后 5 天内采血的长 PVC 部分、每组插入 PVC 所需的时间、两组中针尖的重新定向次数以及每组因任何原因需要重新插入 PVC 的次数。
这项研究是务实的，正在寻找临床相关数据。完成后，它将回答在不仅短期插入获益，而且在插入后 5 天内使用超声引导血管通路是否具有临床相关性的问题。此外，如果这种方法可以确保通过外周静脉导管采血，它可以在围手术期节省资源-特别是考虑到全球范围内医务人员短缺的情况下，这是有价值的。如果这一假设得到证实，这一发现可能有助于在围手术期更广泛地实施超声引导的外周血管通路。
ClinicalTrials.gov NCT05156008。注册于 2021 年 12 月 13 日。
