Sequential Compression Device (SCD) for Stabilizing Hemodynamics in the Beach Chair Position

September 4, 2012 updated by: Frank Christian Pott, MD, Bispebjerg Hospital

Stabilizing Cerebral and Circulatory Hemodynamics During Shoulder Surgery in the Beach Chair Position Using Sequential Compression Device (SCD) or TED Stockings Compared to a Control Group

This study is a 3-legged randomized study examining whether during shoulder surgery performed in the beach chair position active compressions of the lower leg with a sequential compression device (SCD) have a superior effect on stabilizing cerebral and circulatory hemodynamics when compared to TED stockings or a control group without any stockings.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study examines whether during shoulder surgery performed in the beach chair position active compressions of the lower leg with a sequential compression device (SCD) have a superior effect on stabilizing cerebral and circulatory hemodynamics when compared to TED stockings or a control group without any stockings.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen N
      • Copenhagen, Copenhagen N, Denmark, 2200
        • Recruiting
        • Bispebjerg Hospital
        • Principal Investigator:
          • Frank Pott, MD, DMsc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients undergoing elective shoulder surgery

Exclusion Criteria:

  • untreated hypertension
  • no pulse in a. dorsalis pedis or a.tibialis posterior
  • leg ulcers
  • failed scalenous blockade

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequential compression device
During arthroscopic shoulder surgery, an SCD device will be applied to the patients legs during surgery. Cerebral oxygenation and circulatory parameters will be recorded continuously throughout the surgery. Recordings will be hidden to the primary caregiver.
Device: Sequential compression device
a sequential compression device will be applied to the legs
Other Names:
  • SCD express Kendall
Experimental: TED stockings
During arthroscopic shoulder surgery, TED stockings will be applied to the patients legs during surgery. Cerebral oxygenation and circulatory parameters will be recorded continuously throughout the surgery. Recordings will be hidden to the primary caregiver.
Other: TED stockings
TED stockings will be applied to the patients legs during surgery
Other Names:
  • TED compression stockings, Kendall
No Intervention: Control
no stockings will be applied to the patients legs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cerebral oxygenation
Time Frame: per minute
cerebral oxygenation averaged of 1 min during the operation
per minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ephedrine
Time Frame: throughout duration of anaesthesia, approximately 60 minutes
amount of ephedrine used during surgery
throughout duration of anaesthesia, approximately 60 minutes
cardiac output
Time Frame: per minute
cardiac output averaged over 1 minute during the entire surgery
per minute
Stroke volume
Time Frame: per minute
stroke volume averaged over 1 minute during the entire surgery
per minute
mean arterial pressure
Time Frame: per minute
MAP averaged over 1 minute during the entire surgery
per minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Investigators

  • Principal Investigator: Frank Pott, MD,DMsc, Department of Anesthesiology, Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

February 1, 2012

First Submitted That Met QC Criteria

September 4, 2012

First Posted (Estimate)

September 7, 2012

Study Record Updates

Last Update Posted (Estimate)

September 7, 2012

Last Update Submitted That Met QC Criteria

September 4, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBH290511BRAINshoulderscd

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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