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

Not Applicable
Completed
Conditions
Fluid Overload
Interventions
Device: HUNTLEIGH FLOWTRON ACS900
Registration Number
NCT03789474
Lead Sponsor
All India Institute of Medical Sciences, Rishikesh
Brief Summary

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

Detailed Description

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 .

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group BHUNTLEIGH FLOWTRON ACS900Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.
Primary Outcome Measures
NameTimeMethod
Mean Blood Pressure at T460 minutes after induction

Mean blood pressure measurement at T4

Diastolic Blood Pressure at T1immediately after induction

Diastolic blood pressure measurement at T1

Diastolic Blood Pressure at T330 minutes after induction

Diastolic blood pressure measurement at T3

Mean Blood Pressure at T015 minutes pre induction

Mean blood pressure measurement at T0

Mean Blood Pressure at T1immediately after induction

Mean blood pressure measurement at T1

Heart Rate at T015 minutes pre induction

heart rate monitoring at T0

Heart Rate at T1post induction heart rate

heart rate monitoring at T1

Heart Rate at T460 minutes after induction

heart rate monitoring at T4

Systolic Blood Pressure at T460 min after induction

systolic blood pressure measurement at T4

Diastolic Blood Pressure at T215 minutes after induction

Diastolic blood pressure measurement at T2

Heart Rate at T215 minutes after induction

heart rate monitoring at T2

Systolic Blood Pressure at T1post induction

systolic blood pressure measurement at T1

Mean Blood Pressure at T215 minutes after induction

Mean blood pressure measurement at T2

Femoral Vein Velocity at T015 minutes pre induction

Femoral vein velocity measuement at T0

Femoral Vein Velocity at T6after 30 minutes in post anaesthesia care unit

Femoral vein velocity measurement at T6

Inferior Venacava Diameter (Minimum) at T015 min pre induction

inferior venacava diameter (minimum) meaurement at T0

Inferior Venacava Diameter (Minimum) at T6after 30 min in post anaesthesia care unit

inferior venacava diameter (minimum) meaurement at T6

Mean Blood Pressure at T330 minutes after induction

Mean blood pressure measurement at T3

Heart Rate at T330 minutes after induction

heart rate monitoring at T3

Heart Rate at T6post operative period after 30 min in post anaesthesia care unit

heart rate monitoring at T6

Systolic Blood Pressure at T215 min after induction

systolic blood pressure measurement at T2

Systolic Blood Pressure at T330 min after induction

systolic blood pressure measurement at T3

Diastolic Blood Pressure at T5120 minutes after induction

Diastolic blood pressure measurement at T5

Diastolic Blood Pressure at T6post induction 30 min in post anaesthesia care unit

Diastolic blood pressure measurement at T6

Femoral Vein Velocity Variance15 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 T215 minutes after induction

Femoral artery velocity measurement at T2

Heart Rate at T5120 minutes after induction

heart rate monitoring at T5

Systolic Blood Pressure at T015 min before induction

systolic blood pressure measurement at T0

Systolic Blood Pressure at T5120 min after induction

systolic blood pressure measurement at T5

Systolic Blood Pressure at T6post operative period 30 min in post asnaesthesia care unit

systolic blood pressure measurement at T6

Diastolic Blood Presure at T015 minutes before induction

Diastolic blood pressure measurement at T0

Diastolic Blood Pressure at T460 minutes after induction

Diastolic blood pressure measurement at T4

Mean Blood Pressure at T5120 minutes after induction

Mean blood pressure measurement at T5

Mean Blood Pressure at T6post operative 30 min in post anaesthesia care unit

Mean blood pressure measurement at T6

Femoral Vein Velocity at T215 minutes after induction

Femoral vein velocity measurement at T2

Femoral Artery Velocity at T6after 30 minutes in post anaesthesia care unit

Femoral artery velocity measurement at T6

Inferior Venacava Diameter (Maximum) at T215 min after induction

inferior venacava diameter (maximum) meaurement at T2

Inferior Venacava Diameter (Minimum) at T215 min after induction

inferior venacava diameter (minimum) meaurement at T2

Inferior Venacava Diameter Distensibility Index at T215 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)operative period

fluid requirement (cumulative) during the operative period.

Blood Loss During OperationDuring operating procedure

Total blood loss during operation

Femoral Artery Velocity at T015 minutes pre induction

Femoral artery velocity measurement at T0

Inferior Venacava Diameter (Maximum) at T015 min pre induction

inferior venacava diameter (maximum) meaurement at T0

Inferior Venacava Diameter (Maximum) at T6after 30 min in post anaesthesia care unit

inferior venacava diameter (maximum) meaurement at T6

Inferior Venacava Diameter Collapsibility Index at T015 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 T6after 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

Secondary Outcome Measures
NameTimeMethod
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