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

Primary Purpose

Hypotension

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Sequential compression device
TED stockings
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bispebjerg HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Sequential compression device

TED stockings

Control

Arm 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.

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.

no stockings will be applied to the patients legs

Outcomes

Primary Outcome Measures

cerebral oxygenation
cerebral oxygenation averaged of 1 min during the operation

Secondary Outcome Measures

ephedrine
amount of ephedrine used during surgery
cardiac output
cardiac output averaged over 1 minute during the entire surgery
Stroke volume
stroke volume averaged over 1 minute during the entire surgery
mean arterial pressure
MAP averaged over 1 minute during the entire surgery

Full Information

First Posted
February 1, 2012
Last Updated
September 4, 2012
Sponsor
Bispebjerg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01680393
Brief Title
Sequential Compression Device (SCD) for Stabilizing Hemodynamics in the Beach Chair Position
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sequential compression device
Arm Type
Experimental
Arm 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.
Arm Title
TED stockings
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
no stockings will be applied to the patients legs
Intervention Type
Device
Intervention Name(s)
Sequential compression device
Other Intervention Name(s)
SCD express Kendall
Intervention Description
a sequential compression device will be applied to the legs
Intervention Type
Other
Intervention Name(s)
TED stockings
Other Intervention Name(s)
TED compression stockings, Kendall
Intervention Description
TED stockings will be applied to the patients legs during surgery
Primary Outcome Measure Information:
Title
cerebral oxygenation
Description
cerebral oxygenation averaged of 1 min during the operation
Time Frame
per minute
Secondary Outcome Measure Information:
Title
ephedrine
Description
amount of ephedrine used during surgery
Time Frame
throughout duration of anaesthesia, approximately 60 minutes
Title
cardiac output
Description
cardiac output averaged over 1 minute during the entire surgery
Time Frame
per minute
Title
Stroke volume
Description
stroke volume averaged over 1 minute during the entire surgery
Time Frame
per minute
Title
mean arterial pressure
Description
MAP averaged over 1 minute during the entire surgery
Time Frame
per minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frank Pott, MD, DMsc
Email
frank.pott@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Pott, MD,DMsc
Organizational Affiliation
Department of Anesthesiology, Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
State/Province
Copenhagen N
ZIP/Postal Code
2200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Pott, MD, DMsc

12. IPD Sharing Statement

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

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