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

NCT ID: NCT01680393

Last Updated: 2012-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Sequential compression device

Intervention Type DEVICE

a sequential compression device will be applied to the legs

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.

Group Type EXPERIMENTAL

TED stockings

Intervention Type OTHER

TED stockings will be applied to the patients legs during surgery

Control

no stockings will be applied to the patients legs

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sequential compression device

a sequential compression device will be applied to the legs

Intervention Type DEVICE

TED stockings

TED stockings will be applied to the patients legs during surgery

Intervention Type OTHER

Other Intervention Names

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SCD express Kendall TED compression stockings, Kendall

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Frank Christian Pott, MD

MD, DMSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frank Pott, MD,DMsc

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Bispebjerg Hospital

Locations

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Bispebjerg Hospital

Copenhagen, Copenhagen N, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Frank Pott, MD, DMsc

Role: CONTACT

Email: [email protected]

Other Identifiers

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BBH290511BRAINshoulderscd

Identifier Type: -

Identifier Source: org_study_id