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

This study is currently recruiting participants.

Verified September 2012 by Bispebjerg Hospital

Sponsor:

Information provided by (Responsible Party):

Frank Christian Pott, MD, Bispebjerg Hospital

ClinicalTrials.gov Identifier:

NCT01680393

First received: February 1, 2012

Last updated: September 4, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 1, 2012

Last Updated Date

September 4, 2012

Start Date ^ICMJE

May 2011

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

cerebral oxygenation [ Time Frame: per minute ] [ Designated as safety issue: No ]

cerebral oxygenation averaged of 1 min during the operation

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01680393 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

ephedrine [ Time Frame: throughout duration of anaesthesia, approximately 60 minutes ] [ Designated as safety issue: No ]
amount of ephedrine used during surgery
cardiac output [ Time Frame: per minute ] [ Designated as safety issue: No ]
cardiac output averaged over 1 minute during the entire surgery
Stroke volume [ Time Frame: per minute ] [ Designated as safety issue: No ]
stroke volume averaged over 1 minute during the entire surgery
mean arterial pressure [ Time Frame: per minute ] [ Designated as safety issue: No ]
MAP averaged over 1 minute during the entire surgery

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment

Condition ^ICMJE

Hypotension

Intervention ^ICMJE

Device: Sequential compression device
a sequential compression device will be applied to the legs

Other Name: SCD express Kendall
Other: TED stockings
TED stockings will be applied to the patients legs during surgery

Other Name: TED compression stockings, Kendall

Study Arm (s)

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.

Intervention: Device: Sequential compression device
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.

Intervention: Other: TED stockings
No Intervention: Control
no stockings will be applied to the patients legs

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2012

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Frank Pott, MD, DMsc

frank.pott@gmail.com

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01680393

Other Study ID Numbers ^ICMJE

BBH290511BRAINshoulderscd

Has Data Monitoring Committee

Responsible Party

Frank Christian Pott, MD, Bispebjerg Hospital

Study Sponsor ^ICMJE

Bispebjerg Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Frank Pott, MD,DMsc

Department of Anesthesiology, Bispebjerg Hospital

Information Provided By

Bispebjerg Hospital

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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