A Study to Compare intraoperative fluid responsiveness in patients mechanically ventilated in prone position with and without pre-existing autonomic dysfunction – A prospective controlled observational study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare intraoperative fluid responsiveness (SPV changes) in mechanically ventilated patients in prone position with and without autonomic dysfunction.
研究概览
简要总结
A Prospective single blinded controlled Observational study will be conducted in 60 patients electively posted for surgery in prone position. Patients will be recruited and divided into 2 groups of 30 each based on the results of bedside clinical tests for autonomic dysfunction which will be performed a day before the surgery while doing the pre-anaesthetic check up. Group 1 : Patients with autonomic dysfunction. Group 2 : Patients without autonomic dysfunction. Intra-operatively these patients will be subjected to a fluid bolus of 6% Hydroxyethyl starch and SPV changes (Systolic pressure variation -- dynamic index for fluid therapy) will be monitored along with continuous monitoring of Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) and ECG. The study focuses on comparison of SPV changes in response to intravenous fluid bolus between patients with autonomic dysfunction and patients without autonomic dysfunction.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 to 60 years.
- •Either sex
- •ASA I and II
- •Scheduled for prone position surgery.
排除标准
- •Patients who are not willing to participate.
- •Patients who are unable to perform bed side autonomic dysfunction tests.
- •Patients with abnormal renal function tests and hepatic function tests.
- •Patients with raised baseline and intraoperative blood pressures.
- •Those patients who needed vasoactive drugs during surgery to maintain hemodynamic stability.
- •Patients with Cardiac or Respiratory compromise.
结局指标
主要结局
To compare intraoperative fluid responsiveness (SPV changes) in mechanically ventilated patients in prone position with and without autonomic dysfunction.
时间窗: During the surgery
次要结局
- To compare changes in Heart rate (HR), Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Mean arterial pressure (MAP) in mechanically ventilated patients in prone position with and without autonomic dysfunction.(During the surgery)