Pneumatic Compression of the Legs to Reduce Fluid Demand in Minor Surgery

This study has been completed.
Sponsor:
Collaborators:
Masimo Corp. (loan of medical devices)
Villa Sana GmbH (loan of medical devices)
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT01072305
First received: February 18, 2010
Last updated: February 19, 2010
Last verified: January 2010
  Purpose

Fluid restriction has become of great interest in perioperative care. There is, however, a conflict of interest between fluid restriction and hemodynamic stability. The investigators hypothesized that intermittent pneumatic compression may recruit blood from venous capacity vessels of the lower limbs and thus enable fluid restriction without compromising hemodynamic stability.


Condition Intervention
ENT Surgery
Device: Intermittent pneumatic compression (IPC)
Device: IPC - placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Einfluss Der Intermittierenden Pneumatischen Kompression Der Unteren Extremitäten Auf Den Intraoperativen Flüssigkeitsbedarf

Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • Intraoperative fluid demand [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
    Intraoperative = from induction of general anesthesia to end of the surgical procedure, length of procedure may vary (expected mean duration= 45 min)


Secondary Outcome Measures:
  • hemodynamic stability [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
  • local complications of compression therapy [ Time Frame: perioperative ] [ Designated as safety issue: Yes ]
    perioperative = from induction of general anesthesia (= beginning of compression therapy) to discharge from the hospital.


Enrollment: 70
Study Start Date: February 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intermittent pneumatic compression (IPC)
IPC from induction of general anesthesia to completion of skin closure.
Device: Intermittent pneumatic compression (IPC)
Intermittent pneumatic compression (sequential compression) using a cuff consisting of 12 chambers inflated sequentially from forefoot to groin with decremental inflation pressures (60-38 mmHg), pressure release after complete inflation, and reinflation after 4 seconds pause. ICP cuffs are covered with a frame and drapes for blinding purpose.
Other Names:
  • Lympha Press plus (Model 1033 EL), SN 0248
  • Cuffs: adult
Placebo Comparator: control
IPC - placebo from induction of general anesthesia to closure of the skin
Device: IPC - placebo
ICP cuffs are placed next to/between legs and covered with a frame and drapes for blinding purpose. IPC device is run fom induction of general anesthesia to closure of the skin.
Other Names:
  • Lympha Press plus (Model 1033 EL), SN 0248
  • Cuffs: adult

Detailed Description:

Induction of general anesthesia has a variety of effects on the cardiovascular system, all resulting in impaired hemodynamics. Besides reduced sympathetic tone (Sellgren et al.;Ebert, Kanitz, and Kampine) and direct negative inotropic effect of anesthetic agents(Gare et al.), reduction of cardiac preload (Dahlgren et al.;von Spiegel et al.) plays a major role. Therefore administration of large amounts of i.v. fluid is a common method to counter adverse hemodynamic effects. In addition, substitution for fluid loss during preoperative fasting has been recommended for decades. However, preoperative fasting may lead to less fluid loss than assumed so far(Jacob et al.), and there is increasing evidence that i.v. fluid has many adverse effects. Perioperative weight gain due to fluid overload is an independent predictor of mortality (Lowell et al.). Besides a detrimental effect on gastrointestinal (Nisanevich et al.;Gan et al.;Noblett et al.;Wakeling et al.;Lobo et al.), i.v. fluid may harm the endothelial barrier (Bruegger et al.), possibly leading to a vicious circle of impaired barrier function and increased demand for i.v. fluids (Chappell et al.).

In order to restore cardiac preload, timing, volume, and composition of the fluid are important. Free water (e.g. glucose 5%) or "physiologic saline" have very high volumes of distribution, while colloid application is associated with various adverse effects (Schramko et al.;Dart et al.). This has led to increased interest in intraoperative volume restriction (de Aguilar-Nascimento et al.;McArdle et al.;Muller et al.;Walsh et al.). The ideal i.v. fluid remains to be found, yet it exists already if autotransfusion is considered as fluid therapy. The recruitable amount of blood that is contained in capacity vessels of the legs has not been precisely determined, but estimates range from 100 to 300 ml in each leg (citations). The easiest way to recover the blood that is sequestered from systemic circulation is passive leg raising or Trendelenburg positioning, two methods that have entered intensive care routine to assess volume responsiveness. However in many clinical situations passive leg raising or Trendelenburg position is not feasible, e.g. ear, nose, and throat (ENT) or neurosurgical procedures. Intermittent pneumatic compression (IPC) is an established therapeutic intervention for several indications such as lymphedema, post thrombotic ulcers and arterial claudication (Wienert et al.)and has been recommended for intraoperative prevention of thrombembolism. (Geerts et al.). When used during laparoscopy it can effectively reduce hemodynamic adverse effects of pneumoperitoneum (Alishahi et al.;Bickel et al.;Bickel et al.;Bickel et al.;Kurukahvecioglu et al.). So far its use in a general surgical population to promote volume restriction has not been assessed. We compared fluid demand in patients undergoing minor ENT surgery with or without IPC under a standardized, goal-directed fluid management protocol.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • minor ENT surgery without anticipated relevant blood loss

Exclusion Criteria:

  • ASA Status > II
  • contraindication to IPC
  • unwillingness or inability to give written informed consent
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01072305

Locations
Germany
Medical center of the Rheinische Friedrich Willhelm Univesity of Bonn
Bonn, Germany, 53115
Sponsors and Collaborators
University Hospital, Bonn
Masimo Corp. (loan of medical devices)
Villa Sana GmbH (loan of medical devices)
Investigators
Principal Investigator: Andreas Hoeft, Professor Department of Anesthsiology and Intensive Care, Medical Centerof the Rheinische Friedrich-Wilhelms-University of Bonn
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Andreas Hoeft, Dept. of Anesthesiology and Intensive care, medical center of the Rheinische-Friedrich-Wilhelms-Universität Bonn
ClinicalTrials.gov Identifier: NCT01072305     History of Changes
Other Study ID Numbers: KAIIPC01
Study First Received: February 18, 2010
Last Updated: February 19, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital, Bonn:
fluid restriction
fluid therapy
intraoperative care

ClinicalTrials.gov processed this record on July 24, 2014