Impact of Intra-operative Use of Peristaltic Pneumatic Compression Device on Haemodynamics Vis-à-vis Fluid Requirement During General Anaesthesia and Surgery:A Randomized Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Mean Blood Pressure at T4
研究概览
简要总结
Impact of intraoperative use of pneumatic peristaltic compression device on hemodynamics vis a vis on fluid requirement during general anaesthesia and surgery.
详细描述
Induction of general anaesthesia is associated with cardiac depression and peripheral vasodilatation resulting in hypotension .This hypotension can be corrected by giving intravenous fluid, or the vasoconstrictor. While optimum fluid balances in the perioperative period is of vital importance in overnight fasting patients to correct the fluid deficit, any fluid overload is not only counterproductive to the heart function but is associated with fluid retention in body and edema in postoperative period.
Peristaltic pneumatic compression device, a variant of intermittent sequential compression of legs, uses higher pressure and longer compression cycles to avoid venous stasis in immobilized patients. Sequential compression devices have sleeves with pockets of inflation, which works to squeeze on the appendage in a milking action .The most distal areas will inflate initially, and the subsequent pockets will follow in the same manner. The primary aim of the device is to squeeze blood from the underlying deep veins to proximal side. When the inflatable sleeves deflate, the veins will replenish with blood. The intermittent compressions of the sleeves will ensure the movement of venous blood . Peristaltic Pneumatic Compression of the legs significantly reduces fluid demand and enhances stability during minor ear, nose, and throat surgery. Peristaltic Pneumatic Compression has the potential to support fluid restriction regimens during surgery .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Draping of the legs was done in both the groups.the care observer nor investigator were blinded for the allocation.
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA(American Society of Anaesthesiologists) grade I or II, of both genders
- •Age group of 25 to 50 years
- •Patients undergoing surgeries under GA(General Anaesthesia) for 2-3 hours
排除标准
- •Patients expected to get major blood loss
- •Burns patients.
- •Patients with significant cardiac diseases.
- •Patients with pulmonary diseases and impaired renal function.
- •Lower limb surgeries and abdominal surgeries
结局指标
主要结局
Mean Blood Pressure at T4
时间窗: 60 minutes after induction
Mean blood pressure measurement at T4
Diastolic Blood Pressure at T1
时间窗: immediately after induction
Diastolic blood pressure measurement at T1
Diastolic Blood Pressure at T3
时间窗: 30 minutes after induction
Diastolic blood pressure measurement at T3
Mean Blood Pressure at T0
时间窗: 15 minutes pre induction
Mean blood pressure measurement at T0
Mean Blood Pressure at T1
时间窗: immediately after induction
Mean blood pressure measurement at T1
Heart Rate at T0
时间窗: 15 minutes pre induction
heart rate monitoring at T0
Heart Rate at T1
时间窗: post induction heart rate
heart rate monitoring at T1
Heart Rate at T4
时间窗: 60 minutes after induction
heart rate monitoring at T4
Systolic Blood Pressure at T4
时间窗: 60 min after induction
systolic blood pressure measurement at T4
Diastolic Blood Pressure at T2
时间窗: 15 minutes after induction
Diastolic blood pressure measurement at T2
Mean Blood Pressure at T2
时间窗: 15 minutes after induction
Mean blood pressure measurement at T2
Femoral Vein Velocity at T0
时间窗: 15 minutes pre induction
Femoral vein velocity measuement at T0
Heart Rate at T2
时间窗: 15 minutes after induction
heart rate monitoring at T2
Systolic Blood Pressure at T1
时间窗: post induction
systolic blood pressure measurement at T1
Femoral Vein Velocity at T6
时间窗: after 30 minutes in post anaesthesia care unit
Femoral vein velocity measurement at T6
Inferior Venacava Diameter (Minimum) at T0
时间窗: 15 min pre induction
inferior venacava diameter (minimum) meaurement at T0
Inferior Venacava Diameter (Minimum) at T6
时间窗: after 30 min in post anaesthesia care unit
inferior venacava diameter (minimum) meaurement at T6
Mean Blood Pressure at T3
时间窗: 30 minutes after induction
Mean blood pressure measurement at T3
Heart Rate at T3
时间窗: 30 minutes after induction
heart rate monitoring at T3
Heart Rate at T6
时间窗: post operative period after 30 min in post anaesthesia care unit
heart rate monitoring at T6
Systolic Blood Pressure at T2
时间窗: 15 min after induction
systolic blood pressure measurement at T2
Systolic Blood Pressure at T3
时间窗: 30 min after induction
systolic blood pressure measurement at T3
Diastolic Blood Pressure at T5
时间窗: 120 minutes after induction
Diastolic blood pressure measurement at T5
Diastolic Blood Pressure at T6
时间窗: post induction 30 min in post anaesthesia care unit
Diastolic blood pressure measurement at T6
Femoral Vein Velocity Variance
时间窗: 15 minutes pre induction to 30 minutes in post anaesthesia care unit
the variance in femoral vein velocity was calculated by subtracting the femoral vein velocity pre induction from femoral vein velocity 15 min after induction divided by mean of the two values in percentage
Femoral Artery Velocity at T2
时间窗: 15 minutes after induction
Femoral artery velocity measurement at T2
Heart Rate at T5
时间窗: 120 minutes after induction
heart rate monitoring at T5
Systolic Blood Pressure at T0
时间窗: 15 min before induction
systolic blood pressure measurement at T0
Systolic Blood Pressure at T5
时间窗: 120 min after induction
systolic blood pressure measurement at T5
Systolic Blood Pressure at T6
时间窗: post operative period 30 min in post asnaesthesia care unit
systolic blood pressure measurement at T6
Diastolic Blood Presure at T0
时间窗: 15 minutes before induction
Diastolic blood pressure measurement at T0
Diastolic Blood Pressure at T4
时间窗: 60 minutes after induction
Diastolic blood pressure measurement at T4
Mean Blood Pressure at T5
时间窗: 120 minutes after induction
Mean blood pressure measurement at T5
Mean Blood Pressure at T6
时间窗: post operative 30 min in post anaesthesia care unit
Mean blood pressure measurement at T6
Femoral Vein Velocity at T2
时间窗: 15 minutes after induction
Femoral vein velocity measurement at T2
Femoral Artery Velocity at T6
时间窗: after 30 minutes in post anaesthesia care unit
Femoral artery velocity measurement at T6
Inferior Venacava Diameter (Maximum) at T2
时间窗: 15 min after induction
inferior venacava diameter (maximum) meaurement at T2
Inferior Venacava Diameter (Minimum) at T2
时间窗: 15 min after induction
inferior venacava diameter (minimum) meaurement at T2
Inferior Venacava Diameter Distensibility Index at T2
时间窗: 15 min after induction
the inferior venacava distensibility index for post induction mechanically ventilated patients. It was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by minimum inferior vena cava diameters multiplied by 100 .
FLUID REQUIREMENT (Cumulative)
时间窗: operative period
fluid requirement (cumulative) during the operative period.
Blood Loss During Operation
时间窗: During operating procedure
Total blood loss during operation
Femoral Artery Velocity at T0
时间窗: 15 minutes pre induction
Femoral artery velocity measurement at T0
Inferior Venacava Diameter (Maximum) at T0
时间窗: 15 min pre induction
inferior venacava diameter (maximum) meaurement at T0
Inferior Venacava Diameter (Maximum) at T6
时间窗: after 30 min in post anaesthesia care unit
inferior venacava diameter (maximum) meaurement at T6
Inferior Venacava Diameter Collapsibility Index at T0
时间窗: 15 min pre induction
the collapsibility index was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by mean of the two diameters multiplied by 100.This was done for pre induction spontaneously breathing patients
Inferior Venacava Diameter Collapsibility Index at T6
时间窗: after 30 minutes in post anaesthesia care unit
the collapsibility index was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by mean of the two diameters multiplied by 100.This was done for pre induction spontaneously breathing patients
次要结局
未报告次要终点
研究者
Dr. Masaipeta Kesari
Junior resident,Principal Investigator,Department of Anaesthesiology, All India institute of Medical Sciences, Rishikesh.
All India Institute of Medical Sciences, Rishikesh