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临床试验/NCT06975566
NCT06975566已完成不适用

Long-term Effects of Radial Artery Cannulation on Vessel Diameter, Blood Flow and Fine Motor Skills

Kartal City Hospital0 个研究点目标入组 103 人开始时间: 2016年7月22日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
103
主要终点
90 DAY FOLLOW-UP PERIOD

研究概览

简要总结

This observational study examined changes in blood vessel diameter, blood flow, and fine motor performance after ultrasound-guided radial artery cannulation in adults undergoing elective cardiac surgery. Ultrasound measurements of the radial and ulnar arteries and Purdue Pegboard tests of hand performance were obtained before cannulation and during follow-up for three months. Measurements were compared over time within each participant and between the relevant arteries or hands.

详细描述

This single-centre prospective longitudinal observational study was conducted in the Department of Cardiovascular Surgery at Pamukkale University Faculty of Medicine. Adults aged 18-80 years with American Society of Anesthesiologists physical status I-III who required radial arterial monitoring during elective cardiac surgery were recruited consecutively from 22 July to 2 September 2016. Baseline assessments were performed in all 103 enrolled participants. Radial and ulnar artery internal diameter, peak systolic velocity, end-diastolic velocity, resistive index, pulsatility index, and mean volume flow were assessed before cannulation and at seven subsequent time points over three months. Purdue Pegboard performance was assessed before cannulation, 10 days after baseline, and three months after baseline. Comparisons were made within participants over time, between the radial and ulnar arteries of the cannulated arm, and between the cannulated left and non-cannulated right hands; bimanual performance was assessed separately. Fifty participants completed all reported assessments and were included in the complete-case analysis. The other 53 participants did not complete follow-up because of death (7), severe postoperative morbidity (13), incomplete follow-up attendance (22), or technical or organizational reasons (11). Individual-level partial records for these 53 participants were unavailable for reanalysis. The study received ethics committee approval on 19 July 2016, and written informed consent was obtained before study procedures. The investigation originated as a medical specialty thesis completed in 2017 and was retrospectively registered in 2025.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-80 years.
  • American Society of Anesthesiologists physical status I-III.
  • Scheduled for elective cardiac surgery, including coronary artery bypass grafting, valve surgery, the Bentall procedure, or atrial septal defect repair.
  • Requirement for radial arterial monitoring.

排除标准

  • Emergency surgery.
  • Haemodynamic instability.
  • Planned femoral arterial cannulation.
  • Body mass index >35 kg/m².
  • Peripheral vascular disease.
  • Infection at the puncture site.
  • An abnormal pulse-oximetry-assisted modified Allen screening result.

结局指标

主要结局

90 DAY FOLLOW-UP PERIOD

时间窗: From the first measurement before cannulation to the last measurement after 90 days

Fifty patients requiring arterial cannulation were included in this study. Purdue Pegboard scores were measured for fine motor skill assessment of all patients before the procedure. Over three months fine motor skill scores were measured twice more.

Changes in radial and ulnar artery diameter and Doppler parameters over three months

时间窗: Before cannulation (T0); 1 minute after anesthesia induction (T1); 30 minutes after cannulation (T2); postoperative day 1 (T3); 3 days after cannulation (T4); 10 days (T5), 1 month (T6), and 3 months (T7) after T0.

Internal anteroposterior diameter (mm), peak systolic velocity (cm/s), end-diastolic velocity (cm/s), resistive index (unitless), pulsatility index (unitless), and mean volume flow (mL/min) of the radial and ulnar arteries in the cannulated arm were measured by ultrasound. Each value was the mean of three independent acquisitions. Each parameter was analysed separately for changes from baseline and differences between arteries. T1 was 1 minute after anesthesia induction following cannulation; T2 was 30 minutes after cannulation; T3 was postoperative day 1; T4 was 3 days after cannulation; T5, T6 and T7 were 10 days, 1 month and 3 months after baseline, respectively.

Changes in Purdue Pegboard fine motor performance over three months

时间窗: Before cannulation (T0), 10 days after T0 (T5), and 3 months after T0 (T7).

Fine motor performance was assessed using the Purdue Pegboard Test (Model 32020). The right hand, left hand, and both hands together were tested in separate 30-second subtests. Unilateral scores counted successfully inserted pins; bimanual scores counted completed pin pairs, with one pin placed by each hand. Each subtest was repeated three times and the mean score was analysed. Higher scores indicate better performance. The left hand was the cannulated hand and the right hand was the non-cannulated hand. Unilateral performance was compared between hands and over time; bimanual performance was analysed separately over time. The 60-second assembly subtest was not performed.

次要结局

未报告次要终点

研究者

发起方
Kartal City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

AKIN BİLİR

anesthesiology and reanimation specialist, intensive care subspecialist

Kartal City Hospital

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