Clinical trial NCT03789474: Does Fluid Requirement Decrease With the Use of Pneumatic Compression Device on Lower Limbs
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Overload
Lead sponsor: All India Institute of Medical Sciences, Rishikesh
Sponsor class: OTHER_GOV
First posted: 2018-12-28
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: About 60 patients of age group 25 to 50 belonging to American Society of Anesthesiologists (ASA) grade 1 and 2 were allocated to either control or sequential pneumatic compression device group .Allocation was done by sealed envelop technique.In the operating room,in the control group,the device was placed on operating table and was placed next to the patients calves.in the intervention group,the device was placed over calves and inflated during induction of General Anaesthesia (GA) and maintenance.legs were draped in both the groups.Femoral vein velocities were assessed using ultrasound in preoperative period , intraoperatively 15 minutes after induction of anaesthesia and in post-operative period.
Primary purpose: PREVENTION

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Heart Rate at T0
timeFrame: 15 minutes pre induction
measure: Heart Rate at T1
timeFrame: post induction heart rate
measure: Heart Rate at T2
timeFrame: 15 minutes after induction
measure: Heart Rate at T3
timeFrame: 30 minutes after induction
measure: Heart Rate at T4
timeFrame: 60 minutes after induction
measure: Heart Rate at T5
timeFrame: 120 minutes after induction
measure: Heart Rate at T6
timeFrame: post operative period after 30 min in post anaesthesia care unit
measure: Systolic Blood Pressure at T0
timeFrame: 15 min before induction
measure: Systolic Blood Pressure at T1
timeFrame: post induction
measure: Systolic Blood Pressure at T2
timeFrame: 15 min after induction
measure: Systolic Blood Pressure at T3
timeFrame: 30 min after induction
measure: Systolic Blood Pressure at T4
timeFrame: 60 min after induction
measure: Systolic Blood Pressure at T5
timeFrame: 120 min after induction
measure: Systolic Blood Pressure at T6
timeFrame: post operative period 30 min in post asnaesthesia care unit
measure: Diastolic Blood Presure at T0
timeFrame: 15 minutes before induction
measure: Diastolic Blood Pressure at T1
timeFrame: immediately after induction
measure: Diastolic Blood Pressure at T2
timeFrame: 15 minutes after induction
measure: Diastolic Blood Pressure at T3
timeFrame: 30 minutes after induction
measure: Diastolic Blood Pressure at T4
timeFrame: 60 minutes after induction
measure: Diastolic Blood Pressure at T5
timeFrame: 120 minutes after induction
measure: Diastolic Blood Pressure at T6
timeFrame: post induction 30 min in post anaesthesia care unit
measure: Mean Blood Pressure at T0
timeFrame: 15 minutes pre induction
measure: Mean Blood Pressure at T1
timeFrame: immediately after induction
measure: Mean Blood Pressure at T2
timeFrame: 15 minutes after induction
measure: Mean Blood Pressure at T3
timeFrame: 30 minutes after induction
measure: Mean Blood Pressure at T4
timeFrame: 60 minutes after induction
measure: Mean Blood Pressure at T5
timeFrame: 120 minutes after induction
measure: Mean Blood Pressure at T6
timeFrame: post operative 30 min in post anaesthesia care unit
measure: Femoral Vein Velocity at T0
timeFrame: 15 minutes pre induction
measure: Femoral Vein Velocity at T2
timeFrame: 15 minutes after induction
measure: Femoral Vein Velocity at T6
timeFrame: after 30 minutes in post anaesthesia care unit
measure: Femoral Vein Velocity Variance
timeFrame: 15 minutes pre induction to 30 minutes in post anaesthesia care unit
measure: Femoral Artery Velocity at T0
timeFrame: 15 minutes pre induction
measure: Femoral Artery Velocity at T2
timeFrame: 15 minutes after induction
measure: Femoral Artery Velocity at T6
timeFrame: after 30 minutes in post anaesthesia care unit
measure: Inferior Venacava Diameter (Maximum) at T0
timeFrame: 15 min pre induction
measure: Inferior Venacava Diameter (Maximum) at T2
timeFrame: 15 min after induction
measure: Inferior Venacava Diameter (Maximum) at T6
timeFrame: after 30 min in post anaesthesia care unit
measure: Inferior Venacava Diameter (Minimum) at T0
timeFrame: 15 min pre induction
measure: Inferior Venacava Diameter (Minimum) at T2
timeFrame: 15 min after induction
measure: Inferior Venacava Diameter (Minimum) at T6
timeFrame: after 30 min in post anaesthesia care unit
measure: Inferior Venacava Diameter Collapsibility Index at T0
timeFrame: 15 min pre induction
measure: Inferior Venacava Diameter Distensibility Index at T2
timeFrame: 15 min after induction
measure: Inferior Venacava Diameter Collapsibility Index at T6
timeFrame: after 30 minutes in post anaesthesia care unit
measure: FLUID REQUIREMENT (Cumulative)
timeFrame: operative period
measure: Blood Loss During Operation
timeFrame: During operating procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: All India Institute of Medical Sciences, Rishikesh
name: Mukesh Tripathi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: 10.1097/ALN.0b013e31820c3973.
citation: 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.
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. doi: 10.1093/bja/aew363.
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. doi: 10.1001/archsurg.1993.01420200088016.