Shoulder ArthroscopyNCT02291185
Prediction of Fluid Responsiveness Using Dynamic Preload Indices During Arthroscopic Shoulder Surgery in the Beach Chair Position
An observational study of Shoulder Arthroscopy, run by Yonsei University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Shoulder Arthroscopy
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing shoulder arthroscopic surgery in the beach chair position
Who may be able to join
- Above 20 years of age.
- American Society of Anesthesiologists (ASA) Physical Status I, II, III.
- shoulder arthroscopy under Beach-chair position
Who cannot join
- severe functional liver or kidney disease
- diagnosed HF ( NYHA class >3)
- cerebrovascular disease 4. Pregnancy
About this study
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.
- Conditions
- Shoulder Arthroscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
To investigate the ability of SVV adn PPV to predict fluid responsiveness during beach chair position, using ROC curve.
Measured: The participants will be followed up to 5 minutes after fluid challenge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthroscopyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291185
- Sponsor's protocol ID
- 4-2014-0698
- Status last verified
- Aug 2015
- First submitted
- 30 Oct 2014
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Fluid Responsiveness Using Dynamic Preload Indices During Arthroscopic Shoulder Surgery in the Beach Chair Position
- ClinicalTrials.gov ID
- NCT02291185
- Acronym / sponsor ID
- 4-2014-0698
- Conditions
- Shoulder Arthroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing shoulder arthroscopic surgery in the beach chair position
Key inclusion criteria (3 listed)
- Above 20 years of age.
- American Society of Anesthesiologists (ASA) Physical Status I, II, III.
- shoulder arthroscopy under Beach-chair position
Key exclusion criteria (3 listed)
- severe functional liver or kidney disease
- diagnosed HF ( NYHA class >3)
- cerebrovascular disease 4. Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Arthroscopy, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2015.