Basic Hemodynamics in Correlation With Noninvasive Cardiac Output: A Diagnostic Reliability Issue During Percutaneous Nephrolithotomy Bleeding Under Spinal Anesthesia
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
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
Mohamed Abd Latif Ghanim
Associate Professor os anesthesia ICU & Pain medicine.
Mansoura University
