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同侧倾斜体位对右锁骨下静脉置管的影响:一项前瞻性随机试验的研究方案

The effects of ipsilateral tilt position on right subclavian venous catheterization: study protocol for a prospective randomized trial.

作者信息

Jung Dhong Eun, Lee Hyung-Chul, Yoon Hyun-Kyu, Park Hee-Pyoung

机构信息

Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea.

出版信息

Trials. 2018 May 24;19(1):292. doi: 10.1186/s13063-018-2666-8.

Abstract

BACKGROUND

The cross-sectional area of the subclavian vein (csSCV) is an important factor determining the success rate of SCV catheterization. The head-down position increases the csSCV. However, the effects of lateral tilting on subclavian venous cross-sectional area have not yet been explored. In this trial, we test our hypothesis that ipsilateral tilt during right SCV catheterization may significantly increase the csSCV by impeding blood flow to the heart, thereby increasing the primary venipuncture success rate and reducing the complication rate and procedure time.

METHODS/DESIGN: This is a two-staged, prospective, randomized, controlled trial conducted on 237 neurosurgical patients requiring SCV catheterization. Seventeen patients in stage I will be placed in supine, 20° ipsilateral tilt, and 20° contralateral tilt positions in random order. The right csSCV will be measured using ultrasonography at each position. In stage II, 220 patients will be randomly assigned to the ipsilateral tilt group (n = 110) and supine group (n = 110) according to the position for right SCV catheterization. Data on catheterization-related characteristics and complications will be collected during and after catheterization. The primary outcome measures are the right csSCV for stage I and primary venipuncture success rate for stage II. The secondary outcome measures for stage II are time to venipuncture, total catheterization time, first-pass success rate, and complications, such as arterial puncture, hematoma, pneumothorax, air embolism, and catheter misplacement.

DISCUSSION

This is the first trial to investigate the effects of the ipsilateral tilt position on right SCV catheterization. We will attest the beneficial effects of the ipsilateral tilt position on the csSCV and the primary venipuncture success rate during right SCV catheterization. Furthermore, comparisons of the first-pass success rate, complications, and total catheterization time during SCV catheterization in the ipsilateral tilt position vs. the supine position will help us determine which position is better for safe and easy SCV catheterization.

TRIAL REGISTRATION

ClinicalTrials.gov, ID: NCT03296735 . Registered on 25 September 2017 for stage I; NCT03303274 Registered on 6 October 2017 for stage II.

摘要

背景

锁骨下静脉横截面积(csSCV)是决定锁骨下静脉置管成功率的重要因素。头低位可增加csSCV。然而,侧倾对锁骨下静脉横截面积的影响尚未得到研究。在本试验中,我们检验我们的假设,即在右侧锁骨下静脉置管期间同侧倾斜可能通过阻碍血液流向心脏而显著增加csSCV,从而提高首次静脉穿刺成功率并降低并发症发生率和操作时间。

方法/设计:这是一项针对237例需要进行锁骨下静脉置管的神经外科患者进行的两阶段、前瞻性、随机对照试验。第一阶段的17例患者将被随机依次置于仰卧位、同侧倾斜20°和对侧倾斜20°的体位。在每个体位使用超声测量右侧csSCV。在第二阶段,220例患者将根据右侧锁骨下静脉置管的体位随机分为同侧倾斜组(n = 110)和仰卧组(n = 110)。在置管期间和置管后收集与置管相关的特征和并发症的数据。第一阶段的主要结局指标是右侧csSCV,第二阶段的主要结局指标是首次静脉穿刺成功率。第二阶段的次要结局指标是静脉穿刺时间、总置管时间、首次通过成功率以及并发症,如动脉穿刺、血肿、气胸、空气栓塞和导管误置。

讨论

这是第一项研究同侧倾斜体位对右侧锁骨下静脉置管影响的试验。我们将证明同侧倾斜体位在右侧锁骨下静脉置管期间对csSCV和首次静脉穿刺成功率的有益影响。此外,比较同侧倾斜体位与仰卧体位在锁骨下静脉置管期间的首次通过成功率、并发症和总置管时间将有助于我们确定哪种体位更适合安全、简便的锁骨下静脉置管。

试验注册

ClinicalTrials.gov,标识符:NCT03296735。于2017年9月25日注册第一阶段;NCT03303274于2017年10月6日注册第二阶段。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f8ec/5968706/4b186c012a86/13063_2018_2666_Fig1_HTML.jpg

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