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临床试验/CTRI/2025/08/092880
CTRI/2025/08/092880尚未招募2/3 期

COMPARISON BETWEEN THE ULTRASOUND GUIDED DYNAMIC NEEDLE TIP POSITIONING USING SHORT-AXIS, OUT-OF-PLANE APPROACH AND LONGITUDINAL OBLIQUE AXIS APPROACH FOR RADIAL ARTERY CANNULATION IN PATIENTS UNDERGOING EMERGENCY EXPLORATORY LAPROTOMY WITH PERIOPERATIVE HYPOTENSION - A PROSPECTIVE RANDOMIZED NON-INFERIORITY TRIAL

UCMS and GTB Hospital1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年8月28日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
52
试验地点
1
主要终点
Time for successful cannulation

研究概览

简要总结

The two main techniques for Ultrasound guided radial artery RA cannulation are Longaxis,in plane LA IP and short-axis out plane SA OP technique Longitudinal oblique axis LOA is a modified LA IP technique which provides wider visualized area as well direct needle visualization. LOA and Dynamic needle tip positioning DNTP have come up as an alternative techniques for LA IP and SA OP respectively  SA OP with DNTP has been established as the desirable technique however LOA has emerged as the promising technique in terms of higher success rate We hypothesize LOA to be non inferior to SA OP with DNTP  On literature search these techniques have not been evaluated in patients with difficult cannulation eg obesity and hypotension All routine standard monitors will be attached The hypotension will be managed by vasopressors and inotropes as per the protocol  In all patients Modified Allens test will be performed with the arm placed on a flat armrest in moderate dorsiflexion 30 degree to 45 degree which will be achieved by placing a towel under the dorsal aspect of wrist  Patients will be randomized into group D and O In group D DNTP using SA OP will be used and in group O LOA approach will be used  Various parameters like Time for successful cannulation Imaging time first attempt success rate number of attempts  failure rate  overall success rate complications and operator satisfaction rate will be recorded

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Consenting adult patients of either sex aged 18-60 yrs undergoing emergency exploratory laparotomy with perioperative hypotension and on inotropes.

排除标准

  • Negative Modified Allens test Anatomic variation of the radial artery Peripheral arterial disease Infection or burn at the site of insertion History of coagulation disorders History of forearm surgery Radial artery cannulation in the past 30 days BMI more than.

结局指标

主要结局

Time for successful cannulation

时间窗: interval from the start of US probe manipulation to the successful placement of the catheter within the vessel lumen achieving an endpoint of arterial waveform on the monitor.

次要结局

  • First attempt success rate number of attempts failure rate(Imaging time)

研究者

发起方
UCMS and GTB Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Geetanjali T Chilkoti

UCMS & GTB Hospital

研究点 (1)

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