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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Bispebjerg Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- cerebral oxygenation
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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: Sequential compression device (Device)
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: TED stockings (Other)
Control
no stockings will be applied to the patients legs
Outcomes
Primary Outcomes
cerebral oxygenation
Time Frame: per minute
cerebral oxygenation averaged of 1 min during the operation
Secondary Outcomes
- ephedrine(throughout duration of anaesthesia, approximately 60 minutes)
- cardiac output(per minute)
- Stroke volume(per minute)
- mean arterial pressure(per minute)
Investigators
Frank Christian Pott, MD
MD, DMSc
Bispebjerg Hospital