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

Not Applicable

• Conditions: Hypotension

• Registration Number: NCT01680393
• Lead Sponsor: Bispebjerg Hospital

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 Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-02-01
• Status Verified: 2012-09
• Study First Submitted QC: 2012-09-04
• Last Update Submitted: 2012-09-04
• Study First Posted: 2012-09-07
• Last Update Posted: 2012-09-07
• Primary Completion: 2012-11
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
cerebral oxygenation	per minute	cerebral oxygenation averaged of 1 min during the operation

Secondary Outcome Measures

Name	Time	Method
ephedrine	throughout duration of anaesthesia, approximately 60 minutes	amount of ephedrine used during surgery
cardiac output	per minute	cardiac output averaged over 1 minute during the entire surgery
Stroke volume	per minute	stroke volume averaged over 1 minute during the entire surgery
mean arterial pressure	per minute	MAP averaged over 1 minute during the entire surgery

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Copenhagen N, Denmark