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临床试验/CTRI/2025/07/090337
CTRI/2025/07/090337尚未招募不适用

A prospective observational study: Ultrasonography monitored changes in the right subclavian vein diameter induced by Trendelenburg position as a predictor for hypotension associated with general anaesthesia.

PACIFIC MEDICAL COLLEGE AND HOSPITAL UDAIPUR1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年7月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
To see ultrasonography monitored changes in the right subclavian vein diameter induced by Trendelenburg position as a predictor for hypotension associated with general anaesthesia

研究概览

简要总结

A prospective observational study will be conducted on 70 patients admitted to Pacific Medical College and Hospital, Udaipur, over a period of two years after due Institutional Ethical Committee approval. Informed written consent would be taken from the patients. This study is designed as a prospective observational study, and patients are enrolled according to the elective surgeries under general anaesthesia. Consecutive sampling will be used to enrol patients until the desired sample size of 70 is reached.

Before the surgery, baseline data including patient demographics (age, sex, weight, height), medical history, and specific details about the scheduled surgery will be collected. A high-resolution ultrasound machine with a high-frequency (7.5-MHz) linear array probe will be used. The right subclavian vein diameter will be measured at two points in a sub-clavicular long-axis view parallel to the right clavicle :

(1) In the supine position before anaesthesia induction.

(2) In the Trendelenburg position (15 degrees) after anaesthesia induction.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • 1.Patients scheduled for a surgical procedure requiring general anaesthesia.
  • 2.Patients giving informed consent.
  • 3.American Society of Anaesthesiologists (ASA) Grade (I/II).
  • 4.Adult patients aged between 18-60 years.

排除标准

  • 1.Refusal of consent.
  • 2.American Society of Anaesthesiologists (ASA) Grade (III/IV/V).
  • 3.Patients with known cardiovascular diseases or any other significant comorbid conditions that significantly alter hemodynamic responses.
  • 4.Patients with contraindications to the Trendelenburg position.
  • 5.Patients with a history of significant venous anomalies or thrombosis in the subclavian vein.

结局指标

主要结局

To see ultrasonography monitored changes in the right subclavian vein diameter induced by Trendelenburg position as a predictor for hypotension associated with general anaesthesia

时间窗: Intra operative period

次要结局

  • To predict hypotension using collapsibility index of right subclavian vein(Perioperative and intraoperative periods)

研究者

发起方
PACIFIC MEDICAL COLLEGE AND HOSPITAL UDAIPUR
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Aryaman Arora

Pacific medical college and hospital

研究点 (1)

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