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

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ClinicalTrials.gov Identifier: NCT03789474
Recruitment Status : Completed
First Posted : December 28, 2018
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Masaipeta Kesari, All India Institute of Medical Sciences, Rishikesh

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

Condition or disease Intervention/treatment Phase
Fluid Overload Device: HUNTLEIGH FLOWTRON ACS900 Not Applicable

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 .


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Draping of the legs was done in both the groups.the care observer nor investigator were blinded for the allocation.
Primary Purpose: Prevention
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
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : July 30, 2018
Actual Study Completion Date : July 30, 2018

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



Primary Outcome Measures :
  1. fluid requirement during general anaesthesia and surgery [ Time Frame: 18 months ]
    total fluid administered to the participants to maintain hemodynamic stability



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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789474


Sponsors and Collaborators
All India Institute of Medical Sciences, Rishikesh
Investigators
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Principal Investigator: Mukesh Tripathi, MD All India Institute of Medical Sciences, Rishikesh

Publications of Results:
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Responsible Party: Dr. Masaipeta Kesari, Junior resident,Principal Investigator,Department of Anaesthesiology, All India institute of Medical Sciences, Rishikesh., All India Institute of Medical Sciences, Rishikesh
ClinicalTrials.gov Identifier: NCT03789474     History of Changes
Other Study ID Numbers: AIIMSRishikesh
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes