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临床试验/NCT03828175
NCT03828175已完成不适用

Basic Hemodynamics in Correlation With Noninvasive Cardiac Output: A Diagnostic Reliability Issue During Percutaneous Nephrolithotomy Bleeding Under Spinal Anesthesia

Mansoura University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年2月1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
入组人数
40
试验地点
1
主要终点
Stroke volume index (SVI)

研究概览

简要总结

This prospective pre and post-quasi-descriptive single group interventional study will be done at urology and nephrology center -Mansoura University during the year 2019, for a 3-month duration, starting 1-2-2019 till 1-4-2019 after approval of IRB (Institutional Review Board) code no R/18.03.103 on 5/5/2018, Mansoura Faculty of Medicine. correlating Basic hemodynamics with noninvasive cardiac output for diagnostic reliability during percutaneous nephrolithotomy hidden bleeding under spinal anesthesia

详细描述

Hypothesis: On the concept of patient safety, using basic noninvasive monitoring tools (Blood pressure, HR, pulse oximetry O2 Saturation) are late and deceiving and non-reliable hemodynamic measuring tools in diagnosing the progression of the silent hidden bleeding during percutaneous nephrolithotomy surgery (PCNL) operations and necessitate adding noninvasive COP (bioimpedance based) monitor for minute to minute detection of the hemodynamic changes during (PCNL) surgery (necessitates high level spinal anesthesia and prolonged prone position with its hemodynamic burden, carries high risk of inaccessible uncontrollable bleeding).

The aim of the work:

Targeting more intraoperative patient safety by determination of the credibility of basic hemodynamic monitors in reflecting the real cardiopulmonary functions during PCNL operation (high risk is hidden bleeding) under prone position spinal anesthesia.

Achieved by using correlation between intraoperative noninvasive thoracic bioimpedance [COP -oxygenation] monitor and the usually used basic intraoperative [hemodynamic-oxygenation] monitoring systems; two outcome categories will be correlated; a)-Circulatory category: thoracic bioimpedance based COP hemodynamic parameters including (cardiac output COP-stroke volume SV -stroke index SI- cardiac index CI-cardiac performance index CPI-stroke volume variability SVV, systemic vascular resistance SVR, systemic vascular resistance index SVRI) correlation with the usual basic hemodynamic monitoring dependent parameters noninvasive blood pressure NIBP (systolic SBP and mean MAP) and the heart rate HR. b)- Oxygenation category: (Oxygen delivery (Do2), Oxygen delivery index (Do2I), correlation with the basic monitor pulse oximeter oxygen saturation (Sao2).

Correlation will be done at 3 times first basal (just after prone position adjustment and before PCNL puncture, after 60 min then after 120 minutes of prone position adjustment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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
否

入选标准

  • •Patients scheduled for percutaneous nephrolithotomy endoscopic operation
  • •Both sexes,
  • •Age 18 - 70 years.
  • •PCNL operation time ≥120 minutes.

排除标准

  • •Patient refusal.
  • •PCNL operation time <120 minutes.
  • •Hypersensitivity to amide local anesthetics.
  • •General contraindications to spinal anesthesia, coagulopathy.
  • •Cardiac, hepatic, renal or respiratory failure.
  • •Difficult communication.

研究组 & 干预措施

cop variables

Other

non invasive cop vsriables correlation to basic monitoring variables during prone position spinal anesthesia intervention pcnl operation at basic ,1hour and 2hours .

干预措施: spinal anesthesia monitoring (Procedure)

结局指标

主要结局

Stroke volume index (SVI)

时间窗: up to 120 minutes.

continuous stroke volume index (stroke volume divided by the body weight) during prone position spinal anesthesia

次要结局

未报告次要终点

研究者

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

Mohamed Abd Latif Ghanim

Associate Professor os anesthesia ICU & Pain medicine.

Mansoura University

研究点 (1)

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