Correlation Between IN-TArget Time for Mean Arterial Pressure and Stroke Volume During Major Urological Surgery and Tissue Perfusion: the INTAT Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Correlation between the time-in target of SV and the pCO2 gap at the end of surgery
研究概览
简要总结
In this prospective observational study investigators aim to seek for any possible correlation between the venous to arterial carbon dioxide difference (pCO2 gap) at the end of surgery and the percentage of time spent above a predefined threshold of stroke volume (SV) andn mean arterial pressure (MAP).
详细描述
During major urological surgery (i.e. cistectomy) investigators will use a minimally invasive hemodynamic monitoring system (Flotrac - Vigileo, Edwards ) to guide fluid therapy and vasopressors administration. More specifically stroke volume target will be defined as the maximum SV after a series of fluid boluses, with a 10% tolerance. MAP was considered adequate if above 65 mmHg. After the induction of anesthesia, then each hour during surgery until the end of surgical procedure investigators will assess the time of adherence to the hemodynamic protocol (in terms of both SV and MAP) and the correspondent pCO2 gap. Investigators expect to find an inverse proportionality between the two parameters explored.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for major urological surgery
- •ASA 1-2-3
排除标准
- •pregnancy
- •obesity with a BMI > 35
- •controindications to central venous catheter positioning
- •end-stage renal disease
结局指标
主要结局
Correlation between the time-in target of SV and the pCO2 gap at the end of surgery
时间窗: an average of 8 hours
The co-primary outcome will explore the hypothesis that patient with higher adherence of SV within the maximum value with a 10% tolerance, will have a lower pCO2 gap at the end of surgery
Correlation between the time-in target of MAP and the pCO2 gap at the end of surgery
时间窗: an average of 8 hours
The primary outcome will explore the hypothesis that patient with higher adherence of MAP levels above 65 mmHg will have a lower pCO2 gap at the end of surgery
次要结局
- duration of hospitalization(an average of 2 weeks)
- incidence of postoperative overall complications(up to 30 days)
研究者
RUSSO ANDREA
Medical Doctor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS