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

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

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

Study Overview

• Status: Completed
• Conditions: Fluid Overload
• Intervention / Treatment: Device: HUNTLEIGH FLOWTRON ACS900

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 .

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group A; No intervention was done ,served as a control group.
Experimental: Group B; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, Rishikesh
• Investigators: Principal Investigator: Mukesh Tripathi, MD, All India Institute of Medical Sciences, Rishikesh

Publications and helpful links

General Publications

• 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: 10.1097/ALN.0b013e31820c3973.
• 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):852-861. doi: 10.1093/bja/aew447.
• 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. doi: 10.1093/bja/aew363.
• 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. doi: 10.1001/archsurg.1993.01420200088016.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: December 27, 2018
• First Submitted That Met QC Criteria: December 27, 2018
• First Posted (Actual): December 28, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: AIIMSRishikesh

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: study protocol,stastical analysis plan,informed consent form.
• IPD Sharing Time Frame: june 2020 till june 2021
• IPD Sharing Access Criteria: after obtaining consent.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes