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

B

Bispebjerg Hospital

Status

Unknown

Conditions

Hypotension

Treatments

Device: Sequential compression device
Other: TED stockings

Study type

Interventional

Funder types

Other

Identifiers

NCT01680393
BBH290511BRAINshoulderscd

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 3 patient groups

Sequential compression device
Experimental group
Description:
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.
Treatment:
Device: Sequential compression device
TED stockings
Experimental group
Description:
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.
Treatment:
Other: TED stockings
Control
No Intervention group
Description:
no stockings will be applied to the patients legs

Trial contacts and locations

1

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Central trial contact

Frank Pott, MD, DMsc

Data sourced from clinicaltrials.gov

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