Does Fluid Requirement Decrease With the Use of Pneumatic Compression Device on Lower Limbs

Study Overview
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Brief Summary
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Impact of intraoperative use of pneumatic peristaltic compression device on hemodynamics vis a vis on fluid requirement during general anaesthesia and surgery.

Detailed Description
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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 .

Official Title
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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

Conditions
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Fluid Overload

Intervention / Treatment
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* Device: HUNTLEIGH FLOWTRON ACS900


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: About 60 patients of age group 25 to 50 belonging to American Society of Anesthesiologists (ASA) grade 1 and 2 were allocated to either control or sequential pneumatic compression device group .Allocation was done by sealed envelop technique.In the operating room,in the control group,the device was placed on operating table and was placed next to the patients calves.in the intervention group,the device was placed over calves and inflated during induction of General Anaesthesia (GA) and maintenance.legs were draped in both the groups.Femoral vein velocities were assessed using ultrasound in preoperative period , intraoperatively 15 minutes after induction of anaesthesia and in post-operative period.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group A<br>No intervention was done ,served as a control group. | |
| Experimental: Group B<br>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used. | Device: HUNTLEIGH FLOWTRON ACS900<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate at T0 | heart rate monitoring at T0 | 15 minutes pre induction | 
| Heart Rate at T1 | heart rate monitoring at T1 | post induction heart rate | 
| Heart Rate at T2 | heart rate monitoring at T2 | 15 minutes after induction | 
| Heart Rate at T3 | heart rate monitoring at T3 | 30 minutes after induction | 
| Heart Rate at T4 | heart rate monitoring at T4 | 60 minutes after induction | 
| Heart Rate at T5 | heart rate monitoring at T5 | 120 minutes after induction | 
| Heart Rate at T6 | heart rate monitoring at T6 | post operative period after 30 min in post anaesthesia care unit | 
| Systolic Blood Pressure at T0 | systolic blood pressure measurement at T0 | 15 min before induction | 
| Systolic Blood Pressure at T1 | systolic blood pressure measurement at T1 | post induction | 
| Systolic Blood Pressure at T2 | systolic blood pressure measurement at T2 | 15 min after induction | 
| Systolic Blood Pressure at T3 | systolic blood pressure measurement at T3 | 30 min after induction | 
| Systolic Blood Pressure at T4 | systolic blood pressure measurement at T4 | 60 min after induction | 
| Systolic Blood Pressure at T5 | systolic blood pressure measurement at T5 | 120 min after induction | 
| Systolic Blood Pressure at T6 | systolic blood pressure measurement at T6 | post operative period 30 min in post asnaesthesia care unit | 
| Diastolic Blood Presure at T0 | Diastolic blood pressure measurement at T0 | 15 minutes before induction | 
| Diastolic Blood Pressure at T1 | Diastolic blood pressure measurement at T1 | immediately after induction | 
| Diastolic Blood Pressure at T2 | Diastolic blood pressure measurement at T2 | 15 minutes after induction | 
| Diastolic Blood Pressure at T3 | Diastolic blood pressure measurement at T3 | 30 minutes after induction | 
| Diastolic Blood Pressure at T4 | Diastolic blood pressure measurement at T4 | 60 minutes after induction | 
| Diastolic Blood Pressure at T5 | Diastolic blood pressure measurement at T5 | 120 minutes after induction | 
| Diastolic Blood Pressure at T6 | Diastolic blood pressure measurement at T6 | post induction 30 min in post anaesthesia care unit | 
| Mean Blood Pressure at T0 | Mean blood pressure measurement at T0 | 15 minutes pre induction | 
| Mean Blood Pressure at T1 | Mean blood pressure measurement at T1 | immediately after induction | 
| Mean Blood Pressure at T2 | Mean blood pressure measurement at T2 | 15 minutes after induction | 
| Mean Blood Pressure at T3 | Mean blood pressure measurement at T3 | 30 minutes after induction | 
| Mean Blood Pressure at T4 | Mean blood pressure measurement at T4 | 60 minutes after induction | 
| Mean Blood Pressure at T5 | Mean blood pressure measurement at T5 | 120 minutes after induction | 
| Mean Blood Pressure at T6 | Mean blood pressure measurement at T6 | post operative 30 min in post anaesthesia care unit | 
| Femoral Vein Velocity at T0 | Femoral vein velocity measuement at T0 | 15 minutes pre induction | 
| Femoral Vein Velocity at T2 | Femoral vein velocity measurement at T2 | 15 minutes after induction | 
| Femoral Vein Velocity at T6 | Femoral vein velocity measurement at T6 | after 30 minutes in post anaesthesia care unit | 
| Femoral Vein Velocity Variance | 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 | 15 minutes pre induction to 30 minutes in post anaesthesia care unit | 
| Femoral Artery Velocity at T0 | Femoral artery velocity measurement at T0 | 15 minutes pre induction | 
| Femoral Artery Velocity at T2 | Femoral artery velocity measurement at T2 | 15 minutes after induction | 
| Femoral Artery Velocity at T6 | Femoral artery velocity measurement at T6 | after 30 minutes in post anaesthesia care unit | 
| Inferior Venacava Diameter (Maximum) at T0 | inferior venacava diameter (maximum) meaurement at T0 | 15 min pre induction | 
| Inferior Venacava Diameter (Maximum) at T2 | inferior venacava diameter (maximum) meaurement at T2 | 15 min after induction | 
| Inferior Venacava Diameter (Maximum) at T6 | inferior venacava diameter (maximum) meaurement at T6 | after 30 min in post anaesthesia care unit | 
| Inferior Venacava Diameter (Minimum) at T0 | inferior venacava diameter (minimum) meaurement at T0 | 15 min pre induction | 
| Inferior Venacava Diameter (Minimum) at T2 | inferior venacava diameter (minimum) meaurement at T2 | 15 min after induction | 
| Inferior Venacava Diameter (Minimum) at T6 | inferior venacava diameter (minimum) meaurement at T6 | after 30 min in post anaesthesia care unit | 
| Inferior Venacava Diameter Collapsibility Index at T0 | 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 | 15 min pre induction | 
| Inferior Venacava Diameter Distensibility Index at T2 | 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 . | 15 min after induction | 
| Inferior Venacava Diameter Collapsibility Index at T6 | 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 | after 30 minutes in post anaesthesia care unit | 
| FLUID REQUIREMENT (Cumulative) | fluid requirement (cumulative) during the operative period. | operative period | 
| Blood Loss During Operation | Total blood loss during operation | During operating procedure |