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

Fluid Overload Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03789474
• Other study ID #: AIIMSRishikesh
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: August 2020
• Source: All India Institute of Medical Sciences, Rishikesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Fluid Overload

Intervention

Device:
• HUNTLEIGH FLOWTRON ACS900

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, Rishikesh

References & Publications (4)

Kaufmann KB, Stein L, Bogatyreva L, Ulbrich F, Kaifi JT, Hauschke D, Loop T, Goebel U. Oesophageal Doppler guided goal-directed haemodynamic therapy in thoracic surgery - a single centre randomized parallel-arm trial. Br J Anaesth. 2017 Jun 1;118(6):852-8 — View Citation

Kiefer N, Theis J, Putensen-Himmer G, Hoeft A, Zenker S. Peristaltic pneumatic compression of the legs reduces fluid demand and improves hemodynamic stability during surgery: a randomized, prospective study. Anesthesiology. 2011 Mar;114(3):536-44. doi: 10 — View Citation

Meng L, Heerdt PM. Perioperative goal-directed haemodynamic therapy based on flow parameters: a concept in evolution. Br J Anaesth. 2016 Dec;117(suppl 3):iii3-iii17. Review. — View Citation

Millard JA, Hill BB, Cook PS, Fenoglio ME, Stahlgren LH. Intermittent sequential pneumatic compression in prevention of venous stasis associated with pneumoperitoneum during laparoscopic cholecystectomy. Arch Surg. 1993 Aug;128(8):914-8; discussion 918-9. — View Citation

Outcome

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