- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02291185
Prediction of Fluid Responsiveness Using Dynamic Preload Indices During Arthroscopic Shoulder Surgery in the Beach Chair Position
August 30, 2015 updated by: Yonsei University
The beach chair position (BCP) has been commonly used for shoulder arthroscopic surgery.
Hemodynamic instability is frequently encountered problem associated with BCP.
In addition, high rates of cerebral desaturation events have been reported during surgery in BCP.
Although fluid loading could alleviate hypotension associated with BCP, it may lead to volume overload.
As an alternative to static indices, dynamic preload indices such as pulse pressure variation (PPV) and stroke volume variation (SVV) were reported to be sensitive predictors of fluid responsivness in several surgical condition.
The investigators will examine the abilities of PPV and SVV to predict fluid responsivness during shoulder arthroscopic surgery in BCP.
Using transesophageal echocardiography (TEE), the investigators will directly estimate the change of cardiac output during BCP.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
42
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients undergoing shoulder arthroscopic surgery in the beach chair position
Description
Inclusion Criteria:
- Above 20 years of age.
- American Society of Anesthesiologists (ASA) Physical Status I, II, III.
- shoulder arthroscopy under Beach-chair position
Exclusion Criteria:
- severe functional liver or kidney disease
- diagnosed HF ( NYHA class >3)
- cerebrovascular disease 4. Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The changes between dynamic preload indices (SVV and PPV) and stroke volume index during beach chair position. We will measure them to evaluate the effect of beach chair position on PPV and SVV.
Time Frame: The participants will be followed up to 5 minutes after fluid challenge.
|
To investigate the ability of SVV adn PPV to predict fluid responsiveness during beach chair position, using ROC curve.
|
The participants will be followed up to 5 minutes after fluid challenge.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
October 30, 2014
First Submitted That Met QC Criteria
November 11, 2014
First Posted (Estimate)
November 14, 2014
Study Record Updates
Last Update Posted (Estimate)
September 1, 2015
Last Update Submitted That Met QC Criteria
August 30, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 4-2014-0698
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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