Clinical Trials Logo
  1. Home
  2. Hypotension
  3. NCT01680393
  4. Details
NCT01680393 Clinical Trial

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

Hypotension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01680393
Other study ID # BBH290511BRAINshoulderscd
Secondary ID
Status Recruiting
Phase N/A
First received February 1, 2012
Last updated September 4, 2012
Start date May 2011
Est. completion date November 2012

Study information
Verified date September 2012
Source Bispebjerg Hospital
Contact Frank Pott, MD, DMsc
Email frank.pott@gmail.com
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Sequential compression device
a sequential compression device will be applied to the legs
Other:
• TED stockings
TED stockings will be applied to the patients legs during surgery

Locations
Country Name City State
Denmark Bispebjerg Hospital Copenhagen Copenhagen N

Sponsors (1)
Lead Sponsor Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary cerebral oxygenation cerebral oxygenation averaged of 1 min during the operation per minute No
Secondary ephedrine amount of ephedrine used during surgery throughout duration of anaesthesia, approximately 60 minutes No
Secondary cardiac output cardiac output averaged over 1 minute during the entire surgery per minute No
Secondary Stroke volume stroke volume averaged over 1 minute during the entire surgery per minute No
Secondary mean arterial pressure MAP averaged over 1 minute during the entire surgery per minute No
See also
  Status Clinical Trial Phase
Completed NCT04062994 - A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
Active, not recruiting NCT02016599 - Effects of Transitional Circulation in ELBW Infants
Recruiting NCT05836610 - Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates Phase 4
Suspended NCT02315937 - Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography' N/A
Completed NCT02907931 - Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status N/A
Completed NCT03215797 - Phenylephrine or Norepinephrine for a Better Hemodynamic Stability Phase 3
Recruiting NCT02532270 - Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring N/A
Completed NCT02437799 - Dicrotic Notch and Hypotension at Caesarean Under Spinal Anaesthesia N/A
Completed NCT02802683 - Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery Phase 4
Completed NCT02146898 - The Severity Of Hypotension Comparing Three Positions During Spinal Anesthesia For Cesarean Delivery N/A
Completed NCT01930227 - Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hypotension After Spinal Anesthesia in Parturients N/A
Not yet recruiting NCT01941472 - Transcutaneous pO2, Transcutaneous pCO2 and Central Venous pO2 Variations to Predict Fluid Responsiveness N/A
Recruiting NCT01434251 - Treatment of Hypotension of Prematurity (TOHOP) N/A
Completed NCT01592669 - Passive Leg Raising Attenuates and Delays Tourniquet Deflation-induced Hypotension and Tachycardia N/A
Withdrawn NCT01183741 - Accuracy of Non-Invasive Blood Pressure Measurement in Adults Phase 3
Completed NCT00991627 - Different Approaches to Maternal Hypotension During Cesarean Section Phase 4
Withdrawn NCT00750516 - Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet
Completed NCT00115726 - Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure Phase 4
Recruiting NCT05513066 - Management Arterial Hypotension During Planned Caesarean Section, Intravenous Ephedrine/Phenylephrine Mixture Versus Intravenous Baby Noradrenaline
Completed NCT04089644 - Manual vs Closed-loop Control of Mean Arterial Pressure N/A