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Completed

NCT Number: NCT03789474

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

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

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Key information

Conditions

Fluid Overload Edema Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HUNTLEIGH FLOWTRON ACS900

Device

Primary outcomes

  1. Heart Rate at T0

    Time frame: 15 minutes pre induction

    heart rate monitoring at T0

  2. Heart Rate at T1

    Time frame: post induction heart rate

    heart rate monitoring at T1

  3. Heart Rate at T2

    Time frame: 15 minutes after induction

    heart rate monitoring at T2

  4. Heart Rate at T3

    Time frame: 30 minutes after induction

    heart rate monitoring at T3

  5. Heart Rate at T4

    Time frame: 60 minutes after induction

    heart rate monitoring at T4

  6. Heart Rate at T5

    Time frame: 120 minutes after induction

    heart rate monitoring at T5

  7. Heart Rate at T6

    Time frame: post operative period after 30 min in post anaesthesia care unit

    heart rate monitoring at T6

  8. Systolic Blood Pressure at T0

    Time frame: 15 min before induction

    systolic blood pressure measurement at T0

  9. Systolic Blood Pressure at T1

    Time frame: post induction

    systolic blood pressure measurement at T1

  10. Systolic Blood Pressure at T2

    Time frame: 15 min after induction

    systolic blood pressure measurement at T2

  11. Systolic Blood Pressure at T3

    Time frame: 30 min after induction

    systolic blood pressure measurement at T3

  12. Systolic Blood Pressure at T4

    Time frame: 60 min after induction

    systolic blood pressure measurement at T4

  13. Systolic Blood Pressure at T5

    Time frame: 120 min after induction

    systolic blood pressure measurement at T5

  14. Systolic Blood Pressure at T6

    Time frame: post operative period 30 min in post asnaesthesia care unit

    systolic blood pressure measurement at T6

  15. Diastolic Blood Presure at T0

    Time frame: 15 minutes before induction

    Diastolic blood pressure measurement at T0

  16. Diastolic Blood Pressure at T1

    Time frame: immediately after induction

    Diastolic blood pressure measurement at T1

  17. Diastolic Blood Pressure at T2

    Time frame: 15 minutes after induction

    Diastolic blood pressure measurement at T2

  18. Diastolic Blood Pressure at T3

    Time frame: 30 minutes after induction

    Diastolic blood pressure measurement at T3

  19. Diastolic Blood Pressure at T4

    Time frame: 60 minutes after induction

    Diastolic blood pressure measurement at T4

  20. Diastolic Blood Pressure at T5

    Time frame: 120 minutes after induction

    Diastolic blood pressure measurement at T5

  21. Diastolic Blood Pressure at T6

    Time frame: post induction 30 min in post anaesthesia care unit

    Diastolic blood pressure measurement at T6

  22. Mean Blood Pressure at T0

    Time frame: 15 minutes pre induction

    Mean blood pressure measurement at T0

  23. Mean Blood Pressure at T1

    Time frame: immediately after induction

    Mean blood pressure measurement at T1

  24. Mean Blood Pressure at T2

    Time frame: 15 minutes after induction

    Mean blood pressure measurement at T2

  25. Mean Blood Pressure at T3

    Time frame: 30 minutes after induction

    Mean blood pressure measurement at T3

  26. Mean Blood Pressure at T4

    Time frame: 60 minutes after induction

    Mean blood pressure measurement at T4

  27. Mean Blood Pressure at T5

    Time frame: 120 minutes after induction

    Mean blood pressure measurement at T5

  28. Mean Blood Pressure at T6

    Time frame: post operative 30 min in post anaesthesia care unit

    Mean blood pressure measurement at T6

  29. Femoral Vein Velocity at T0

    Time frame: 15 minutes pre induction

    Femoral vein velocity measuement at T0

  30. Femoral Vein Velocity at T2

    Time frame: 15 minutes after induction

    Femoral vein velocity measurement at T2

  31. Femoral Vein Velocity at T6

    Time frame: after 30 minutes in post anaesthesia care unit

    Femoral vein velocity measurement at T6

  32. Femoral Vein Velocity Variance

    Time frame: 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

  33. Femoral Artery Velocity at T0

    Time frame: 15 minutes pre induction

    Femoral artery velocity measurement at T0

  34. Femoral Artery Velocity at T2

    Time frame: 15 minutes after induction

    Femoral artery velocity measurement at T2

  35. Femoral Artery Velocity at T6

    Time frame: after 30 minutes in post anaesthesia care unit

    Femoral artery velocity measurement at T6

  36. Inferior Venacava Diameter (Maximum) at T0

    Time frame: 15 min pre induction

    inferior venacava diameter (maximum) meaurement at T0

  37. Inferior Venacava Diameter (Maximum) at T2

    Time frame: 15 min after induction

    inferior venacava diameter (maximum) meaurement at T2

  38. Inferior Venacava Diameter (Maximum) at T6

    Time frame: after 30 min in post anaesthesia care unit

    inferior venacava diameter (maximum) meaurement at T6

  39. Inferior Venacava Diameter (Minimum) at T0

    Time frame: 15 min pre induction

    inferior venacava diameter (minimum) meaurement at T0

  40. Inferior Venacava Diameter (Minimum) at T2

    Time frame: 15 min after induction

    inferior venacava diameter (minimum) meaurement at T2

  41. Inferior Venacava Diameter (Minimum) at T6

    Time frame: after 30 min in post anaesthesia care unit

    inferior venacava diameter (minimum) meaurement at T6

  42. Inferior Venacava Diameter Collapsibility Index at T0

    Time frame: 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

  43. Inferior Venacava Diameter Distensibility Index at T2

    Time frame: 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 .

  44. Inferior Venacava Diameter Collapsibility Index at T6

    Time frame: 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

  45. FLUID REQUIREMENT (Cumulative)

    Time frame: operative period

    fluid requirement (cumulative) during the operative period.

  46. Blood Loss During Operation

    Time frame: During operating procedure

    Total blood loss during operation

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Rishikesh

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 28, 2018
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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