Effect of Tidal Volume Challenge on Reliability of Plethysmography Variability Index in Hepatobiliary and Pancreatic Surgeries.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- detection of best cut-off value of ΔPVI6-8 by using tidal volume challenge.
研究概览
简要总结
The aim of this study is to investigate whether a temporary increase in tidal volume can predict fluid responsiveness in patients receiving a low tidal volume ventilation in hepatobiliary and pancreatic surgeries.
The hypothesis of this study is that a temporary increase in tidal volume from 6 to 8 ml/kg would improve the predictability of PVI in patients receiving low tidal volume ventilation in surgical procedures with large fluid shift as hepatobiliary and pancreatic procedures.
详细描述
Common hepatobiliary and pancreatic procedures include repair of lacerations, drainage of abscesses, and resection of primary or metastatic neoplasms. Care of patients undergoing hepatobiliary and pancreatic surgeries in the perioperative period is often challenging because of coexisting medical problems and debilitation found in many patients and because of the potential for significant operative blood loss. Hepatobiliary and pancreatic surgeries have been associated with high mortality and morbidity rates, but recent advances in anesthetic and surgical management have significantly reduced the operative risk.
Studies have shown that intraoperative optimization of cardiac output by repeated volume loading reduces postoperative morbidity and shortens hospital stay following abdominal surgery. However, unnecessary intravenous fluids may be deleterious, and intraoperative fluid restriction has been shown to improve clinical outcomes. During major hepatobiliary and pancreatic surgeries, intravascular volume expansion is constantly required but the safety margin of fluid management is quite narrow. The thought of fluid responsiveness has been progressively used in order to improve the fluid management of critically ill patients. Over the past two decades, many studies have been performed searching for the best index to predict fluid responder in a variety of clinical situations. recent studies have shown that what is called dynamic indexes of fluid responsiveness such as stroke volume variation (SVV), pulse pressure variation (PPV) and others are obviously superior to the more commonly measured static preload variables e.g. pulmonary artery occlusion pressure and central venous pressure.
Plethysmography variability index (PVI) is a dynamic variation parameter that automatically and continuously calculates the respiratory variations in the plethysmographic waveform acquired by the pulse oximeter. The PVI is presented as a safe and useful parameter for evaluating the fluid responsiveness of perioperative patients who underwent major abdominal surgery and for critically ill patients. Several studies have shown that PVI may predict fluid responsiveness in patients undergoing noncardiac surgeries as well as those under mechanical ventilation in the intensive care unit. However, the accuracy of the PVI is unclear for hepatobiliary and pancreatic operations that may have major cardiovascular changes and/or hyperdynamic circulation. Also, there are still limited studies investigating the direct relationship of PVI and cardiac preload status.
PVI is based on the respiratory variations in the pulse oximetry plethysmographic waveform amplitude and various factors that affect lung mechanics, including tidal volume (VT) could also influence PVI values and It is presumed that the effect of tidal volume reaches significance at >8 mL/kg Several studies have shown that dynamic indicators of fluid responsiveness do not reliably predict fluid response during low tidal volume ventilation whereas there is currently a growing trend towards a reduction in tidal volume, not only in ICU patients with acute lung injury but also in patients with healthy lungs undergoing surgery.
The 'tidal volume challenge' is a novel test proposed to improve the reliability of dynamic indexes in predicting fluid responsiveness in patients receiving low tidal volume ventilation. In a recent study testing the tidal volume challenge on some dynamic indexes, it is found that the changes obtained by transiently increasing tidal volume (tidal volume challenge) are superior to dynamic index itself in predicting fluid responsiveness during low tidal volume ventilation. However, no studies use this novel test to know the reliability of PVI in predicting fluid responsiveness in patients receiving low tidal volume ventilation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years undergoing hepatic, pancreatic or biliary tumor resection
排除标准
- •Preoperative cardiac arrhythmias
- •Peripheral vascular disease
- •Low left ventricular function (ejection fraction < 40%)
- •Significant valvular heart disease
- •Intra-cardiac shunts
- •Pulmonary hypertension
- •Fulminant hepatic failure.
结局指标
主要结局
detection of best cut-off value of ΔPVI6-8 by using tidal volume challenge.
时间窗: 2 minutes after performing a "tidal volume challenge"
By Youden index \[sensitivity + (specificity - 1)\]
次要结局
- Detection of sensitivity of PVI6 measured by masimo radical 7 equipment..(2 minutes before tidal volume challenge when tidal volume of patient is 6ml/kg)
- Detection of specificity of PVI6 measured by masimo radical 7 equipment..(1 minute before tidal volume challenge when tidal volume of patient is 6ml/kg)
- Detection of best cut off of percentage ΔPVI6-8 measured by masimo radical 7 equipment.(2 minutes after performing tidal volume challenge)
- Detection of sensitivity of ΔPVI6-8 measured by masimo radical 7 equipment.(2 minutes after performing tidal volume challenge)
- Detection of sensitivity of percentage ΔPVI6-8 measured by masimo radical 7 equipment.(2 minutes after performing tidal volume challenge)
- Detection of specificity of ΔPVI6-8 measured by masimo radical 7 equipment.(2 minutes after performing tidal volume challenge)
- Detection of specificity of percentage ΔPVI6-8 measured by masimo radical 7 equipment.(2 minutes after performing tidal volume challenge)
- Detection of sensitivity of PVI8 measured by masimo radical 7 equipment.(1 minute after tidal volume challenge when tidal volume of patient is 8ml/kg)
- Detection of specificity of PVI8 measured by masimo radical 7 equipment.(1 minute after tidal volume challenge, when tidal volume of patient is 8ml/kg.)
- Detection of sensitivity of Perfusion Index measured by masimo radical 7 equipment.(1 minute before and 1 minte after tidal volume challenge (patient's tidal volume 6 and 8 ml/kg))
- Detection of specificity of Perfusion Index measured by masimo radical 7 equipment.(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of sensitivity of Cardiac Index measured by electrical cardiometry and transoesophageal Doppler.(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of specificity of Cardiac Index measured by electrical cardiometry and transoesophageal Doppler.(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of sensitivity of Cardiac Output measured by electrical cardiometry and transoesophageal Doppler.(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of sensitivity of Stroke Volume measured by electrical cardiometry and transoesophageal Doppler..(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of specificity of Stroke Volume measured by electrical cardiometry and transoesophageal Doppler..(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of sensitivity of Stroke Volume Index measured by electrical cardiometry and transoesophageal Doppler.(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of specificity of Stroke Volume Index measured by electrical cardiometry and transoesophageal Doppler.(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of sensitivity of Stroke Volume variation measured by electrical cardiometry and transoesophageal Doppler.(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of specificity of Stroke Volume variation measured by electrical cardiometry and transoesophageal Doppler.(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of sensitivity of Systemic vascular resistance measured by electrical cardiometry and transoesophageal Doppler.(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of specificity of Systemic vascular resistance measured by electrical cardiometry and transoesophageal Doppler.(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of sensitivity of Heart Rate measured by transoesophageal Doppler and masimo radical 7 equipment(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of specificity of Heart Rate measured by transoesophageal Doppler and masimo radical 7 equipment(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of sensitivity of central venous pressure measured by central venous catheter transducer.(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of specificity of central venous pressure measured by central venous catheter transducer.(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of sensitivity of Thoracic Fluid Content measured by electrical cardiometry.(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of specificity of Thoracic Fluid Content measured by electrical cardiometry.(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of sensitivity of corrected flow time measured by electrical cardiometry and transoesophageal Doppler.(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of specificity of corrected flow time measured by electrical cardiometry and transoesophageal Doppler.(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of specificity of Cardiac Output measured by electrical cardiometry and transoesophageal Doppler.(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of sensitivity of contractility index measured by electrical cardiometry.(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of specificity of contractility index measured by electrical cardiometry.(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of sensitivity of mean arterial blood pressure by invasive arterial blood pressure transducer(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
- Detection of specificity of mean arterial blood pressure by invasive arterial blood pressure transducer(1 minute before and 1 minute after tidal volume challenge (when patient's tidal volume 6 and 8 ml/kg))
研究者
Hany M Yassin, MD
Associate professor
Fayoum University Hospital