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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 1, 2012
CompletedFirst Posted
Study publicly available on registry
September 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedSeptember 7, 2012
September 1, 2012
1.5 years
February 1, 2012
September 4, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
cerebral oxygenation
cerebral oxygenation averaged of 1 min during the operation
per minute
Secondary Outcomes (4)
ephedrine
throughout duration of anaesthesia, approximately 60 minutes
cardiac output
per minute
Stroke volume
per minute
mean arterial pressure
per minute
Study Arms (3)
Sequential compression device
EXPERIMENTALDuring 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.
TED stockings
EXPERIMENTALDuring 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.
Control
NO INTERVENTIONno stockings will be applied to the patients legs
Interventions
a sequential compression device will be applied to the legs
TED stockings will be applied to the patients legs during surgery
Eligibility Criteria
You may qualify if:
- adult patients undergoing elective shoulder surgery
You may not qualify if:
- untreated hypertension
- no pulse in a. dorsalis pedis or a.tibialis posterior
- leg ulcers
- failed scalenous blockade
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bispebjerg Hospital
Copenhagen, Copenhagen N, 2200, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank Pott, MD,DMsc
Department of Anesthesiology, Bispebjerg Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, DMSc
Study Record Dates
First Submitted
February 1, 2012
First Posted
September 7, 2012
Study Start
May 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
September 7, 2012
Record last verified: 2012-09