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

Not Applicable

• Conditions: Hypotension
• Interventions: Device: Sequential compression device; Other: TED stockings

• 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

Arm && Interventions

Group	Intervention	Description
Sequential compression device	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.
TED stockings	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.

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