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
Phase: NA
Conditions: Fluid Overload
Sponsor: All India Institute of Medical Sciences, Rishikesh

1 
 
      NCT03789474                   
Date: 21-12-2016. 
 
 
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 
 
Name of Candidate: 
Dr. M. KESARI 
Junior resident, 
Department of Anaesthesiology, 
All India Institute of Medical Sciences, Rishikesh. 

2 
 
 
 
 
 
Introduction 
 
Induction of general anaesthesia is associated with cardiac depression and peripheral 
vasodilatation resulting in hypotension.(1) This hypotension can be corrected by giving 
intravenous fluid,(2) 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(2)(3)(4)(5). 
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”. (9).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.(9) 
We hypothesize that the intermittent pneumatic compression of the lower extremity is 
associated with increased venous return and avoid pooling of blood in peripheral 
circulation and might help in maintenance of hemodynamic targets during anaesthesia 
and surgery(8). The aim of present thesis is to compare hemodynamic status of patients 
during anesthesia by using intermittent pneumatic compression pump vis-à-vis 
intravenous fluid or vasoconstrictor requirement. 

3 
 
Review of literature. 
 
 
Induction of general anaesthesia causes certain hemodynamic changes .There is a fall 
in mean blood pressure and decrease in heart rate with most of the intravenous 
anaesthetic agents (table 1).Volatile agents also produce dose dependent depression of 
left ventricular(LV) ,right ventricular and left atrial myocardial contractility, LV diastolic 
function, and LV-arterial coupling in normal heart. Volatile anaesthetics depress 
baroreceptor reflex control of arterial pressure to varying degrees.(1) 
To counter this, fluid is being administered to improve preload and to counteract 
hypotension induced by general anaesthetic agents but there are no standard 
recommendations regarding the amount of fluid to be given. Fluid overload may be 
deleterious causing poor outcome in post -operative period.(4) 
In the low-risk patient undergoing low risk or ambulatory surgery, high-volume 
crystalloid infusions of the order of 20–30 ml kg−1 (e.g. 2 litres over 30 min to the 
average adult) improves ambulatory anaesthesia outcomes such as pain, nausea, 
dizziness.On the other hand, high-risk patients undergoing major surgery seem to 
benefit from a ‘restrictive’ fluid regimen. This remains to be clearly defined, but a good 
working definition in a patient with normal renal function would be that intraoperative 
urine output is kept between 0.5 and 1.0 ml kg−1hr-1 .(2) 
For patients who are undergoing mild to moderately invasive procedures a baseline 
crystalloid infusion of 1 to 2 mL/kg per hour with crystalloid boluses (20 to 40 mL/kg and 
for major surgical procedures, a fluid restricted or goal-directed fluid approach over a 
fixed volume regimen is recommended. The traditional practice of fixed volume fluid 
administration should be abandoned. Crystalloid (0.5 to 1 mL/kg per hour) is 
administered to replace sensible and insensible losses and colloid is used to replace 
plasma losses (blood).(6) 

4 
 
Restoring preload can be done by passive leg raising or trendelenburg positioning or by 
compression devices .the former two are not feasible in many situations. External 
compression of extremities acts similarly to the above mentioned maneuvers. 
Compression devices can be intermittent compression devices or graduated 
compression stockings. Intermittent compression devices can be single or multi 
chamber type/sequential compression device. 
 
Compression with the single-chambered device produced a significant rise in venous 
blood flow velocity; however, this could not be maintained and the results indicate a 
higher average velocity was achieved with the sequential gradient device. The 
sequential gradient device also moved a greater volume of blood and achieved a higher 
average blood flow rate. The time between deflation of the sleeve and return of a phasic 
respiratory signal was greater after compression with the sequential gradient device.(7) 
 
A significant effect of stockings may be to reduce pooling of blood in deep veins by 
mechanically preventing distension of the vessels. The major drawback with stockings 
is their fitting. Thigh-length stockings, in particular, appear to be difficult to apply and 
wear in some circumstances. The danger is that poorly fitted stockings, or those of an 
incorrect shape and size, could produce “tourniquets” at the proximal end, causing 
ischemia, and an increased risk of thrombosis.(9) 
 
Peristaltic pneumatic 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.(8) 
 
Intermittent sequential pneumatic compression by the Lympha-press fully reverses the 
cardiac depression and head-up tilt position and overcompensates for the state of 
peripheral venous stasis induced by pressure pneumoperitoneum during laparoscopic 
surgery. (10) 

5 
 
The application of sequential pneumatic compression to the lower limbs is associated 
with minor increases in mean arterial blood pressure, with moderate reduction of 
cardiac output and heart rate.(11) 
 
Diagnostic accuracy of passive leg raising for prediction of fluid responsiveness in 
adults by systematic review and meta-analysis of clinical studies. Passive leg raising- 
induced changes in cardiac output can reliably predict fluid responsiveness regardless 
of ventilation mode and cardiac rhythm. PLR-changes in Cardiac Output has a 
significantly higher predictive value than PLR-changes in arterial Pulse Pressure.(12) 
Partial pressure of End Tidal Carbon dioxide (PETCO2) is the partial pressure or 
maximal concentration of carbon dioxide (CO2) at the end of an exhaled breath, which 
is expressed as a percentage of CO2 or mmHg. PETCO2 effectively tracked changes in 
Cardiac Output during the Passive Leg Raising maneuver and predicted fluid 
responsiveness in patients with acute circulatory failure with fixed minute ventilation, 
assuming a constant tissue CO2 production.(13) 
The volume status of patient can be assessed by noninvasive method of 
ultrasonography of abdomen to measure diameter of inferior vena cava and femoral 
vein blood flow velocity. 
Changes in stroke volume, radial pulse pressure, and peak velocity of femoral artery 
flow induced by passive leg raising are accurate and interchangeable indices for 
predicting fluid responsiveness in non-intubated patients with severe sepsis or acute 
pancreatitis. The Delta velocity of femoral artery flow >or=8% predicted fluid 
responsiveness with sensitivity of 86% and specificity of 80%.(14) 

6 
 
A significant reduction in common femoral venous flow occurs during laparoscopic 
cholecystectomy coincident with pneumoperitoneum and reverse Trendelenburg's 
position. Intermittent sequential pneumatic compression reversed that effect, returning 
peak systolic velocity to normal.(15) 
 
Inferior Vena Cava (IVC) collapsibility index 
In a patient requiring ventilator support, there is an inversion of the cyclic changes in 
IVC diameter, leading to increases in the inspiratory phase and decreases in the 
expiratory phase. The respiratory variations in IVC diameter in a mechanically ventilated 
patient are therefore only observed when right atrial pressure is normal, that is low. In a 
patient presenting with signs of circulatory insufficiency, this finding may indicate 
hypovolemia. Absence of respiratory variations in IVC diameter in a mechanically 
ventilated patient presenting with signs of circulatory insufficiency suggests that volume 
expansion will be ineffective in most of the cases. 
 
The IVC distensibility index. It is expressed as the difference between the value of the 
maximum diameter and the minimum diameter, divided by the minimum of the two 
values. 
IVC distensibility (evidence in vented patients only)(16). 
Barbier et al: distensibility index: (Dmax-Dmin)/Dmin x 100%. Threshold of 18% 
has 90% sensitivity and specificity for volume responsiveness. 
Feissel 
et 
al: 
respiratory 
variation 
in 
IVC 
diameter: 
(Dmax- 
Dmin)/((Dmax+Dmin)/2). Threshold of 12% predicted fluid responders with a 
Positive predicitive Value of 93% and Negative Predictive Value of 92% 
IVC diameter (evidence in all patients): 
Meta-analysis of studies measuring IVC size in shock patients found all had IVC 
<15mm 
Feissel et al found that 29 of 30 fluid non-responders had IVC>15mm, 2 of 16 
fluid responders had IVC>25mm(16). 

7 
 
HYPOTHESIS 
We hypothesize that the peristaltic pneumatic compression of the lower extremity will be 
associated with increased venous return and avoid pooling of blood in peripheral 
circulation and avoids hypotension, thereby maintaining the hemodynamic stability. The 
aim of present thesis is to compare hemodynamic status of patients during anesthesia 
by using peristaltic pneumatic compression device vis-à-vis intravenous fluid or 
vasoconstrictor requirement. 
 
 
 
 
Aims and objectives. 
 
AIMS: 
 
To study effect of Intermittent Pneumatic Compression devices on hemodynamic 
effects of induction of General Anesthesia and maintenance. 
 
 
 
 
OBJECTIVES 
 
 
Primary objectives 
1. Compare the need of total fluid requirement between the study groups. 
2. Compare vasoconstrictor requirement between the study groups. 
 
 
Secondary objectives 
 
 
1. Compare the fluid status of the patient by assessing inferior vena cava diameter and 
blood flow. 
2. Compare haemodynamic complications. 
3. Compare Postoperative recovery and morbidity. 

8 
 
 
STUDY DESIGN 
 
A randomized prospective study will be conducted in department of Anaesthesiology, at 
the All India Institute of Medical Sciences, Rishikesh, over a period of 1-2 years. The 
informed written consent will be taken before enrolment by the patients. Randomization 
of the patient into two groups will be done by sealed envelope technique 
 
 
SAMPLE SIZE 
 
All the groups will receive fluid therapy according to an identical goal directed 
protocol. The primary endpoint is the difference in total volume of fluid administration. 
An a priori sample size analysis based on the assumption of normal distribution 
indicated that 30 patients per group would provide 80% power to detect a statistically 
significant difference of 500 versus 750 ml with a SD of 300 ml (Cohen's d = 0.72) at an 
α level of 0.05. 

9 
 
 
 
Patient inclusion criteria: 
Material & Methods 
 
The study would comprise of 3 groups of 30 patients each, of ASA grade I or II, of both 
genders, in the age group of 25 to 50 years, posted for surgeries under General 
Anaesthesia for anesthesia lasting 2-3 hours. 
Patient exclusion criteria: 
 
Patients expected to get major blood loss. 
Burns patients. 
Patients with significant cardiac diseases. 
Patients with pulmonary diseases. 
Patients with impaired renal function. 
 
Study Groups: 
 
Peristaltic Pneumatic Compression (PPC) devices would be placed in both the groups. 
 
In Group 1 – The PPC shall be placed on operating table, next to patients calves during 
the procedure. 
In Group 2 – The PPC shall be placed over calves and inflated during induction of 
General Anaesthesia and maintenance. 
Upon arrival in the operating room, standard monitoring including electrocardiogram, 
Non-invasive arterial blood pressure (NIBP), heart rate (HR), pulse oximetry (SpO2) 
were applied and venous access will be established. 
Anaesthesia will be induced with intravenous fentanyl (1-2 µg/ kg), propofol (1-2mg/kg), 
and vecuronium (0.08-0.1 mg/kg). Neuromuscular monitoring (NMT) will be applied 
following induction of anaesthesia. Patient will be mask ventilated till train of four (TOF) 
ratio comes to 0. Direct laryngoscopy will be done and patient will be intubated with 
PVC endotracheal tube. Correct position of tube will be confirmed by auscultation. 
Anaesthesia will be maintained with oxygen (33%) with nitrous oxide (77%) and 
sevoflurane and top up of vecuronium (0.05 mg/kg) according to neuromuscular 

10 
 
function monitoring. Anaesthesia depth will be monitored with BIS monitoring and 
maintained between 40 to 50 levels on DRAGER PRIMUS INFINITY C700. 
Randomization and Blinding Procedure 
 
In the operating room, immediately before induction of anesthesia, patients were 
randomly allocated to groups by a sealed envelope procedure. An operation theatre 
staff assistant applies the compression device to the patient, allocated to PPC group. In 
other groups, the cuffs were placed next to patient’s legs .The device will be covered 
with drapes in both the groups. The compression device was activated in all groups, in 
the absence of attending anaesthesiologist. This is done to remove the bias due to 
compressor noise and cuff motion. The observer will be blind to both the groups and the 
interventions performed. Group allocation will be revealed to anaesthesiologist at the 
end of the surgery. 
 
Fluid management protocol 
 
The following fluid protocol will be used in all patients in the study: 
 
A maintenance infusion of Ringer’s lactate (nirlife® aculife™,aculife healthcare pvt. Ltd.) 
4 ml/kg/hour will be started in each patient before induction of anaesthesia. In the event 
of hypotension (mean arterial blood pressure <60 mmHg for 3 min i.e. consecutive two 
measurement, 250 ml bolus saline will infused in next 5 min. If blood pressure did not 
improve (MAP >60 mmHg), Dopamine (10 µg/kg/min) will be started and titrated to 
maintain MAP >60 mmHg. If there was no improvement by next measurement after 3 
min another bolus of crystalloid (saline 250 ml in 5 min) was repeated. If hypotension 
still persisted or developed again, a bolus of colloid (100 ml gelofusine® B BRAUN 
MEDICAL(I) Pvt.Ltd. in five min was given) was again given. Blood loss of 250 ml or 
more was replaced by 1:1 colloid and by Packed Red Blood Cells, if exceeded 1000 ml. 

11 
 
 
 
 
 
 
Observations; 
 
The following readings shall be taken at 
 
- 
Immediately after induction of anesthesia 
- 
15 min after induction 
- 
30 min after induction 
- 
60 min after induction 
- 
120 min after induction 
 
In all the groups, similar depth of anesthesia shall be maintained by maintaining BIS in a 
fixed range of 40-50. The mean arterial blood pressure by intermittent noninvasive 
arterial blood pressure measurement will be measured and maintained within 20% of 
baseline. 
Parameters 
 
Hemodynamic – Heart Rate and Non-Invasive arterial Blood Pressure, End tidal Carbon 
dioxide (EtCO2). 
We also assess the volume status of patient by noninvasive method of ultrasonography 
of abdomen to measure diameter of inferior vena cava and femoral vein blood flow 
velocity before induction of anaesthesia, 10 min after induction of anesthesia, at the end 
of surgery and in postoperative period. 
Urine output for catheterized patients, by urinary bag volume measurement and for non- 
catheterized patients, by pre-operative and post-operative bladder emptying in 
graduated burette. 

12 
 
Statistical Analysis Plan (SAP) 
 
 
Demographic data are presented as mean value ± SD. For statistical analysis, the 
SPSS software package (version 20, SPSS Inc., Chicago, IL) was used. Demographic 
details were compared using a two-tailed Student t test for independent samples for 
continuous and a chi-square test for nominal and categorical variables. For all other 
comparisons, a two-tailed Mann–Whitney U test was used. Significance was assumed 
at a P value of less than 0.05 in all statistical tests with Bonferroni correction applied for 
secondary outcome parameters. 

13 
 
TABLE 1 
 
 
 
 
 
 
References 
 
 
1. Ronald D.Miller ,Neal H.Cohen ,Lars I. Eriksson, Lee A. Fleischer Jeanine P., 
wiener-kronish, William L Young 
Miller’s anaesthesia 8th edition volume 1 international edition. 
Elsevier Saunders publications,page 706. 
 
 
2. 
Doherty M, Buggy DJ. Intraoperative fluids: how much is too much? 
Br J Anaesth. 2012 Jul;109(1):69-79. doi: 10.1093/bja/aes171. 
 
 
 
3. Brandstrup B, Tonnesen H, Beier-Holgersen R, Hjortso E, Ording H, 
Lindorff-Larsen K, Rasmussen MS, Lanng C, et al: 
Effects of intravenous fluid restriction on postoperative complications: Comparison 
of two perioperative fluid regimens—A randomized assessor-blinded multicenter trial. 
Ann Surg 2003; 238:641–8 

14 
 
 
 
 
4. Chappell D, Jacob M, Hofmann-Kiefer K, Conzen P, Rehm M: 
A rational approach to perioperative fluid management. 
Anesthesiology 2008; 109:723– 40 
 
 
5. Katerina Koniari, John Parissis, Ioannis Paraskevaidis, and Maria Anastasiou-Nana 
Treating volume overload in acutely decompensated heart failure: established 
and novel therapeutic approaches 
Eur Heart J Acute Cardiovasc Care. 2012 Sep; 1(3): 256–268. 
doi: 10.1177/2048872612457044 
 
 
6. Joshi GP. 
Intraoperative fluid restriction improves outcome after major elective 
Gastro-intestinal surgery. 
Anesth Analg. 2005 Aug;101(2):601-5 
 
 
 
7. Janssen H, Treviño C, Williams D. 
Hemodynamic alterations in venous blood flow produced by external 
pneumatic compression. 
J Cardiovasc Surg (Torino). 1993 Oct;34(5):441-7. 
 
 
 
8. Nicholas Kiefer, Judith Theis, Gabriele Putensen-Himmer, Andreas Hoeft, 
Sven Zenker. 
Peristaltic Pneumatic Compression of the Legs Reduces Fluid Demand 
and Improves Hemodynamic Stability during Surgery: A Randomized, 
Prospective Study. 

15 
 
Perioperative Medicine | March 2011 
 
 
9. Rhys J. Morris,and John P. Woodcock 
Evidence-Based Compression 
Prevention of Stasis and Deep Vein Thrombosis 
Ann Surg. 2004 Feb; 239(2): 162–171. 
doi: 10.1097/01.sla.0000109149.77194.6c 
 
 
 
 
10. Siamack Alishahi, Nadir Francis, Sally Crofts, Lesley Duncan,Amitati Bickel , 
and Alfred Cuschieri 
Central and Peripheral Adverse Hemodynamic Changes During 
Laparoscopic Surgery and Their Reversal with a Novel Intermittent Sequential 
Pneumatic Compression Device 
Ann Surg. 2001 Feb; 233(2): 176–182. 
 
 
 
11. Fanelli G, Zasa M, Baciarello M, Mazzani R, Di Cianni S, Rossi M, Casati A 
Systemic hemodynamic effects of sequential pneumatic compression of the 
lower limbs: a prospective study in healthy volunteers. 
J Clin Anesth. 2008 Aug;20(5):338-42. doi: 10.1016/j.jclinane.2008.02.005. 
. 
 
 
 
 
 
 
12. Cavallaro F, Sandroni C, Marano C, La Torre G, Mannocci A, De Waure C, 
Bello G, Maviglia R, Antonelli M. 
Diagnostic accuracy of passive leg raising for prediction of fluid responsiveness 
in adults: systematic review and meta-analysis of clinical studies. 

16 
 
Intensive Care Med. 2010 Sep;36(9):1475-83. doi: 10.1007/s00134-010-1929-y. 
 
 
 
13. Manuel Ignacio Monge García, Anselmo Gil Cano, Manuel Gracia Romero, 
Rocío Monterroso Pintado, Virginia Pérez Madueño, and Juan Carlos Díaz Monrové 
Non-invasive assessment of fluid responsiveness by changes in partial end- 
tidal CO2 pressure during a passive leg-raising maneuver 
Ann Intensive Care. 2012; 2: 9. 
doi: 10.1186/2110-5820-2-9 
 
 
 
14. Préau S, Saulnier F, Dewavrin F, Durocher A, Chagnon JL. 
Passive leg raising is predictive of fluid responsiveness in spontaneously 
breathing patients with severe sepsis or acute pancreatitis. 
Crit Care Med. 2010 Mar;38(3):819-25. doi: 10.1097/CCM.0b013e3181c8fe7a. 
 
 
15. John A. Millard, Bruce B. Hill, DDS Philip S. Cook, et al 
Intermittent Sequential Pneumatic Compression in Prevention of Venous 
Stasis Associated With Pneumoperitoneum during Laparoscopic Cholecystectomy 
Arch Surg. 1993;128(8):914-919. doi:10.1001/archsurg.1993.01420200088016 
 
 
 
16. Tim Gallagher, 
Ultrasound Guided Fluid Assessment Protocol 
Development of a Fluid Resuscitation Protocol Using Inferior Vena Cava 
and Lung Ultrasound 
J crit care 2015 

17 
 
ASSESSMENT FORM 
 
 
 
0 min 
Immediately 
after the 
induction 
After 
15 min 
After 30 
min 
After 
60 min 
After 120 
min 
Spo2 
Heart Rate 
MAP 
PETCO2 
BIS 
Femoral vein blood 
velocity 
IVC Diameter 
IVC distensibility 
Ringer lactate 
Colloid gelofusione 
Dopamine 
PRBC 
Urinary output 

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PARTICIPANT INFORMATION SHEET 
 
PARTICIPANT INFORMED CONSENT FORM (PICF) 
(English) 
 
Participant identification number for this trial:   
 
 
Title of project: 
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 
Name of Principal Investigator: Dr. M. KESARI, 091 8449000510 
 
The information regarding the study has been explained in detail to me, in a language that 
I comprehend, and I have fully understood the contents. 
 
I understand that the information collected about me from my participation in this research 
and sections of any of my medical notes may be looked at by responsible individuals from AIIMS. 
I agree to take part in the above study. 
 
--------------------------------------------- 
Date: 
 
(Signatures / Left Thumb Impression) 
Place: 
Name of the Participant  :   
  
Son / Daughter of 
:   
 
 
Complete postal address :   
 
 
This is to certify that the above consent has been obtained in my presence. 
 
------------------------------ 
 
Signatures of the Principal Investigator 
Date: 
Place: 
 
 
1)  Witness – 1 
2) Witness – 2 
 
------------------------------ 
-------------------------------- 
 
Signatures 
Signatures 
 
 
Name: 
Name: 
 
Address: 
Address 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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