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临床试验/NCT03228329
NCT03228329已完成不适用

Validation of Electrical Cardiometry in Resuscitation of Patients Undergoing Orthotopic Liver Transplantation

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年8月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
stroke volume

研究概览

简要总结

aim of our study to validate electrical cardiometry readings against same readings by transoesophageal echo. we will validate stroke volume (SV) readings stroke volume variation(SVV), index of contractility.

详细描述

Induction of anaesthesia will be by using propofol (2mg.kg) IV, fentanyl (1-2μg. kg) IV and atracurium (0.5 mg.kg) IV. Anaesthesia will be maintained with Sevoflurane adjusted between 1-2% in an air ⁄ oxygen mix (FiO2 0.6), fentanyl infusion at 1-2 μg.kg/h and atracurium infusion at 0.5 mg.kg/ h. Mechanical ventilation will be provided by using a Dräger anaesthesia machine (Dräger Primus®, Germany) using a tidal volume of 6-8 ml.kg with the respiratory rate adjusted to maintain the PaCO2 between 4-4.6 kilopascal (kPa) and positive end expiratory pressure (PEEP) of 5 cmH2O. All patients will be monitored for five lead ECG, peripheral oxygen saturation, noninvasive and invasive arterial blood pressure, temperature, end-tidal carbon dioxide tension, hourly urinary output, and central venous pressure (CVP). A 7-Fr triple lumen CVP catheter (Arrow International Inc, Reading, PA, USA) will be inserted into the right internal jugular vein.

All patients will receive 6ml /kg/h Ringer acetate solution as a maintenance intraoperative fluid. If SVV is more than 15%, the patient will be considered as fluid responder and will receive a 250-ml bolus of albumin 5% to maintain SVV ≤15%. Blood transfusion will be given based on a hemoglobin level (< 7 g/dl). Norepinephrine will be administered if the mean arterial pressure was less than 70 mmHg. Epinephrine will be administered if mean arterial blood pressure was less than 70 mm Hg and the cardiac index was less than 2.5 L/min/m2 despite sufficient volume infusion, to maintain a target cardiac index of 2.5-3.0 L/min/m2

Electrical cardiometry (EC) Examination:

  1. ECG electrodes will be placed on the bare skin of patients in the following positions:

  2. On the left neck below the ear;

  3. Directly above the midpoint of the left clavicle;

  4. Along the left mid-axillary line at the level of the xiphoid process;

  5. Two inches caudal from the third electrode.

  6. Patient characteristics of sex, age, height and weight will be entered into the monitor.

  7. Clocks on the EC and trans esophageal echo (TEE) machine will be synchronized prior to data collection.

  8. The EC monitor will be programmed to capture moving averages of variables based on the previous 10 cardiac cycles and to record those averages every10 s.

  9. Only EC data with a signal quality index (SQI) of >70 will be included in the analysis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA II to IV patients with end-stage liver disease
  • patients undergoing orthotopic living donor liver transplantation
  • age > 18 years

排除标准

  • acute fulminant liver failure
  • age < 18 years

研究组 & 干预措施

cardiometry

Other

fluid boluses will be given when there will be hypovolemia assessed by presence of pulse pressure variations

干预措施: fluid boluses (Other)

结局指标

主要结局

stroke volume

时间窗: 15 minutes after dissection phase.

record stroke volume assessed by noninvasive cardiometry and TEE

次要结局

  • stroke volume variation(15 minutes after dissection phase)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Elayashy Mohamed Ahmed Hassan

clinical professor

Kasr El Aini Hospital

研究点 (1)

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