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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Bispebjerg Hospital.
Recruitment status was  Recruiting
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

February 1, 2012
September 4, 2012
May 2011
November 2012   (final data collection date for primary outcome measure)
cerebral oxygenation [ Time Frame: per minute ] [ Designated as safety issue: No ]
cerebral oxygenation averaged of 1 min during the operation
Same as current
Complete list of historical versions of study NCT01680393 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Sequential Compression Device (SCD) for Stabilizing Hemodynamics in the Beach Chair Position
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Hypotension
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Frank Pott, MD, DMsc frank.pott@gmail.com
Denmark
 
NCT01680393
BBH290511BRAINshoulderscd
No
Frank Christian Pott, MD, Bispebjerg Hospital
Bispebjerg Hospital
Not Provided
Principal Investigator: Frank Pott, MD,DMsc Department of Anesthesiology, Bispebjerg Hospital
Bispebjerg Hospital
September 2012

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