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

NCT01072305 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2010-02-22

No results posted yet for this study

Summary

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.

Conditions

  • ENT Surgery

Interventions

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.

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.

Sponsors & Collaborators

  • Masimo Corp. (loan of medical devices)

    collaborator UNKNOWN

  • Villa Sana GmbH (loan of medical devices)

    collaborator UNKNOWN

  • University Hospital, Bonn

    lead OTHER

Principal Investigators

  • Andreas Hoeft, Professor · Department of Anesthsiology and Intensive Care, Medical Centerof the Rheinische Friedrich-Wilhelms-University of Bonn

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01072305 on ClinicalTrials.gov