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

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.

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

Conditions
-----------------
Hypotension

Intervention / Treatment
-----------------
* Device: Sequential compression device
* Other: TED stockings


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequential compression device<br>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<br>* a sequential compression device will be applied to the legs<br>* Other names: SCD express Kendall;|
| Experimental: TED stockings<br>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<br>* TED stockings will be applied to the patients legs during surgery<br>* Other names: TED compression stockings, Kendall;|
| No Intervention: Control<br>no stockings will be applied to the patients legs | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebral oxygenation | cerebral oxygenation averaged of 1 min during the operation | per minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ephedrine | amount of ephedrine used during surgery | throughout duration of anaesthesia, approximately 60 minutes | 
| cardiac output | cardiac output averaged over 1 minute during the entire surgery | per minute | 
| Stroke volume | stroke volume averaged over 1 minute during the entire surgery | per minute | 
| mean arterial pressure | MAP averaged over 1 minute during the entire surgery | per minute |