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Study of Stroke Volume Variation and Pleth Variability Index as Predictors of Fluid Responsiveness

NCT ID: NCT02122367

Last Updated: 2014-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Brief Summary

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Appropriate indices to guide fluid therapy are essential for effective hemodynamic management during the perioperative period. Values derived from respiratory changes in arterial pressure waveform or plethysmographic waveform such as stroke volume variation and pleth variability index have been demonstrated to be able to predict fluid responsiveness in surgical or critically ill patients. Their ability to predict fluid responsiveness can be affected by factors that influence the arterial tone or the compliance of the respiratory system by position change. The aim of this prospective trial is to investigate the ability of stroke volume variation and pleth variability index to predict fluid responsiveness in the reverse trendelenberg position.

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Detailed Description

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Conditions

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Thyroidectomy Fluid Responsiveness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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stroke volume variation, pleth variability index

stroke volume variation: recorded using the FloTrac/Vigileo system (Edwards Lifesciences)

pleth variability index: recorded using the Masimo Radical-7 monitor (Masimo Corporation, Irvine, CA, USA)

Group Type EXPERIMENTAL

HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada)

Intervention Type OTHER

HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada) 6ml/kg of ideal body weight loading

Interventions

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HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada)

HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada) 6ml/kg of ideal body weight loading

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 20
2. elective robot assisted thyroidectomy

Exclusion Criteria

1. arrhythmia
2. BMI\>30
3. valvular heart disease
4. pul hypertension
5. peripheral artery occlusive disease
6. lung disease
7. right heart failure
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chung-Ang University Hosptial, Chung-Ang University College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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So Young Yang

So young Yang MD,PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chung-Ang University Hospital

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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So-young Yang, clinical assistant professor

Role: CONTACT

[email protected]
82-2-6299-3160

Yong-hun Jung, professor

Role: CONTACT

[email protected]
82-2-6299-2579

Facility Contacts

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Seong Deok Kim, MD.PhD

Role: primary

[email protected]
82-2-6299-2571

Other Identifiers

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Chung-Ang UH

Identifier Type: -

Identifier Source: org_study_id

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