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
  Purpose

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.


Condition Intervention
Hypotension
Device: Sequential compression device
Other: TED stockings

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

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • cerebral oxygenation [ Time Frame: per minute ] [ Designated as safety issue: No ]
    cerebral oxygenation averaged of 1 min during the operation


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: TED compression stockings, Kendall
No Intervention: Control
no stockings will be applied to the patients legs

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680393

Contacts
Contact: Frank Pott, MD, DMsc frank.pott@gmail.com

Locations
Denmark
Bispebjerg Hospital Recruiting
Copenhagen, Copenhagen N, Denmark, 2200
Principal Investigator: Frank Pott, MD, DMsc         
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Principal Investigator: Frank Pott, MD,DMsc Department of Anesthesiology, Bispebjerg Hospital
  More Information

No publications provided

Responsible Party: Frank Christian Pott, MD, MD, DMSc, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01680393     History of Changes
Other Study ID Numbers: BBH290511BRAINshoulderscd
Study First Received: February 1, 2012
Last Updated: September 4, 2012
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Hypotension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014