Prediction of Fluid Responsiveness Using Dynamic Preload... | NCT02291185

Studies
Prediction of Fluid Responsiveness Using Dynamic Preload Indices During Arthroscopic Shoulder Surgery in the Beach Chair Position

NCT02291185

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Sep 1, 2015Estimated

Enrollment

42Actual

Phase

Not provided

Conditions

Shoulder Arthroscopy

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Oct 30, 2014

First Submission Date that Met QC Criteria

Nov 11, 2014

First Posted Date

Nov 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2015

Last Update Posted Date

Sep 1, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Outcomes Module

Primary Outcomes

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.	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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

patients undergoing shoulder arthroscopic surgery in the beach chair position

Sampling Method

Non-Probability Sample