NCT02291185

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

8 months

First QC Date

October 30, 2014

Last Update Submit

August 30, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    The participants will be followed up to 5 minutes after fluid challenge.

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing shoulder arthroscopic surgery in the beach chair position

You may qualify if:

  • Above 20 years of age.
  • American Society of Anesthesiologists (ASA) Physical Status I, II, III.
  • shoulder arthroscopy under Beach-chair position

You may not qualify if:

  • severe functional liver or kidney disease
  • diagnosed HF ( NYHA class \>3)
  • cerebrovascular disease 4. Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2014

First Posted

November 14, 2014

Study Start

November 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 1, 2015

Record last verified: 2015-08