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临床试验/CTRI/2025/01/079191
CTRI/2025/01/079191尚未招募1/2 期

Jugular Venous Pulsation Approach Versus Ultrasound Guided Approach For Internal Jugular Venous Cannulation In Major Elective Surgery: A Randomized, Non inferiority Trial

Department Of Anaesthesiology Aiims Rishikesh1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
Comparison of overall success rate of internal jugular vein cannulation between landmark approach using jugular venous pulsation and ultrasound guided approach.

研究概览

简要总结

Real time ultrasound (US) guided IJV cannulation is the standard of care and has been recommended to reduce complication . However landmark approach for securing IJV cannulation is still practiced routinely for skill acquisition, training, low resource settings and unavailability of ultrasound machine.  It can be presumed that IJV cannulation by jugular venous pulsation approach is as safe as US guided approach as some studies have shown jugular venous pulsation approach as a promising landmark. It needs to be explored in an objective way so that it can be replicated on a large population.  AIM OF THE STUDY is that Success rate of central venous cannulation by landmark approach using jugular venous pulsation is as effective as ultrasound guided approach.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • American Society Of Anaesthesiologists Grade I-III Patients In Which jugular venous pulsation is visible in supine position in at least lower 1/3 of neck undergoing Major Elective Surgery (cardiac and non.

排除标准

  • Emergency and sick patients-American Society of Anaesthesiologists grade IV, Intubated patients.
  • Patients not having visible jugular venous pulsation.
  • Coagulopathies (International normalized ratio more than 1.5, Platelet count less than 50,000).
  • Pathologies like superior vena cava syndrome, head, and neck tumour.
  • Non patency of internal jugular vein, thrombosis of jugular vein .
  • Patients with Body Mass index less than 18.5 kg /square metre.

结局指标

主要结局

Comparison of overall success rate of internal jugular vein cannulation between landmark approach using jugular venous pulsation and ultrasound guided approach.

时间窗: Internal jugular vein cannulation will be considered overall successful if it is achieved within three attempts.

次要结局

  • Comparison of first attempt success rate between landmark approach using jugular venous pulsation and ultrasound guided approach(Internal jugular vein cannulation will be considered successful at first attempt if it is achieved with first needle pass with or without forward and withdrawal movement on the same site.)
  • Comparison of incidence of arterial puncture between landmark approach using Jugular venous pulsation and ultrasound guided approach.(Carotid artery puncture will be defined as unintentional placement of needle or catheter into neck vessels that yielded bright red or pulsatile blood.)
  • Comparison of time taken for successful cannulation between landmark approach using jugular venous pulsation and ultrasound guided approach.(Time for successful cannulation is defined as time taken from ultrasound probe held on neck till successful cannulation of guidewire by Seldinger technique and confirmation of wire by transthoracic USG in subcostal view. In case of JVP guided central venous cannulation it is defined as time taken from identification of puncture site by JVP, till confirmation of wire by transthoracic USG in subcostal bicaval view.)
  • Comparison of hematoma between landmark approach using jugular venous pulsation and ultrasound guided approach.(Hematoma formation will be defined as formation of visible neck swelling at the site of cannulation (attempted cannulation).)
  • Comparison of number of attempts in overall success rate between landmark approach using jugular venous pulsation and ultrasound guided approach.(An Attempt is defined as passage of CVC needle at puncture site without any redirection and without withdrawing needle out of skin. A new site puncture of skin or redirection at the same site will be considered another attempt.)

研究者

发起方
Department Of Anaesthesiology Aiims Rishikesh
申办方类型
Other [na]
责任方
Principal Investigator
主要研究者

Dr Deepak Nehra

Aiims Rishikesh

研究点 (1)

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