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临床试验/NCT05368363
NCT05368363已完成不适用

Accuracy of Preoperative Evaluation of Inferior Vena Cava Collapsibility Index and Caval Aorta Index for Prediction of Hypotension After Induction of General Anaesthesia: "A Prospective Observational Study"

Cairo University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Area under receiver operating characteristic curves (AUROC) of the preoperative IVCCI inprediction of post-induction hypotension

研究概览

简要总结

  1. To estimate sensitivity and specificity of preoperative IVCCI, max aortic diameter and IVC:Ao index as predictors of hypotension after induction of general anesthesia.
  2. To compare accuracy of preoperative values of IVC: Ao index to preoperative IVCCI in prediction of hypotension after induction of general anesthesia.

详细描述

After obtaining approval from the hospital ethics committee, informed consent will be obtained from 102 patients who will undergo elective surgery requiring general anaesthesia in supine position. Patients will be evaluated by history taking and proper examination. Pre-operative investigations will be checked. On the day of surgery, pre-operative fasting for 8 hours will be confirmed.

Upon arrival to the operating room, routine monitors in the form of pulse oximetry, electrocardiogarm and non-invasive blood pressure monitors will be applied. Intravenous line will be secured and routine premedications (ranitidine 50 mg and ondansetron 4 mg) will be administered.

  1. IVC Ultrasonography (IVCCI and IVC:Ao index) :

While the patient is lying supine, the IVC and aorta will be examined before induction of general anaesthesia using a curved ultrasound transducer set to abdominal mode with a B-mode scan (1-5 MHz; Acuson x300; Siemens Healthcare, Seoul, Korea).

The transducer is placed in the subxiphoid region in a longitudinal position. IVC measurements are made just distal to the IVC-hepatic vein junction, approximately 3 to 4 cm distal to the right atrium. The IVC is identified by Doppler waveform, compressibility and phasic collapse with respiration. The maximum (IVCDmax) and minimum (IVCDmin) internal anteroposterior (AP) diameters of the IVC at the end of expiration and inspiration respectively over the same respiratory cycle will be measured. The IVCCI is derived from the equation: (7) IVCCI = [ (IVCDmax - IVCDmin) / IVCDmax ] X 100. To the left of the IVC, the abdominal aorta is visualized 10 mm above the coeliac trunk. The maximum internal AP diameter of the abdominal aorta is measured during systole. The IVC:Ao index is derived by taking the ratio of the maximum IVC diameter during expiration and the maximal abdominal aortic diameter during systole. 2. Induction of anesthesia:

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 - 60 years old
  • Patients undergoing elective surgery under general anesthesia.
  • ASA I, II

排除标准

  • Patients with BMI more than
  • Pregnant patients
  • Emergency cases
  • Patients with a baseline arterial SBP less than 90 mmHg or mean arterial pressure (MAP) less than 70 mmHg.
  • Patients with major severe vascular disease, Unstable angina, Ejection fraction< 40 %, Respiratory distress, Implanted pacemaker or Patients on angiotensin converting enzyme inhibitors or angiotensin receptor blockers
  • Patients with increased intra-abdominal pressure

结局指标

主要结局

Area under receiver operating characteristic curves (AUROC) of the preoperative IVCCI inprediction of post-induction hypotension

时间窗: 5 minutes

Area under receiver operating characteristic curves (AUROC) of the preoperative IVCCI inprediction of post-induction hypotension

次要结局

  • Correlation between each of maximum aortic diameter with the percentage of themaximum decrease in mean arterial pressure after induction of anesthesia(5 minutes)
  • Correlation between each of IVC collapsibility index with the percentage of themaximum decrease in mean arterial pressure after induction of anesthesia(5 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heba Omar Ahmed

Associate professor of Anesthesia, pain management & surgical ICU

Cairo University

研究点 (1)

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