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

NCT01072305 | Completed

• 1 other identifier: KAIIPC01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

fluid restriction; fluid therapy; intraoperative care

Outcome Measures

Primary Outcomes (1)

• Intraoperative fluid demand

  Intraoperative = from induction of general anesthesia to end of the surgical procedure, length of procedure may vary (expected mean duration= 45 min)

  intraoperative

Secondary Outcomes (2)

• hemodynamic stability

  intraoperative

• local complications of compression therapy

  perioperative

Study Arms (2)

Intermittent pneumatic compression (IPC)

EXPERIMENTAL

IPC from induction of general anesthesia to completion of skin closure.

Device: Intermittent pneumatic compression (IPC)

control

PLACEBO COMPARATOR

IPC - placebo from induction of general anesthesia to closure of the skin

Device: IPC - placebo

Interventions

Intermittent pneumatic compression (IPC) DEVICE

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.

Also known as: Lympha Press plus (Model 1033 EL), SN 0248, Cuffs: adult

Intermittent pneumatic compression (IPC)

IPC - placebo DEVICE

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.

Also known as: Lympha Press plus (Model 1033 EL), SN 0248, Cuffs: adult

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• minor ENT surgery without anticipated relevant blood loss

You may not qualify if:

• ASA Status \> II
• contraindication to IPC
• unwillingness or inability to give written informed consent

Sponsors & Collaborators

• University Hospital, Bonn: lead
• Masimo Corp. (loan of medical devices): collaborator
• Villa Sana GmbH (loan of medical devices): collaborator

Study Sites (1)

Medical center of the Rheinische Friedrich Willhelm Univesity of Bonn

Bonn, 53115, Germany

Location

MeSH Terms

Interventions

Intermittent Pneumatic Compression Devices

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Andreas Hoeft, Professor

  Department of Anesthsiology and Intensive Care, Medical Centerof the Rheinische Friedrich-Wilhelms-University of Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 22, 2010
• Study Start: February 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: February 22, 2010

Record last verified: 2010-01

Locations

DE (1)