NCT02122367

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Last Updated

April 24, 2014

Status Verified

April 1, 2014

Enrollment Period

11 months

First QC Date

April 22, 2014

Last Update Submit

April 23, 2014

Conditions

ThyroidectomyFluid Responsiveness

Outcome Measures

Primary Outcomes (2)

  • stroke volume variation

    5 minutes after volume replacement

  • pleth variability index

    5 minutes after volume replacement

Study Arms (1)

stroke volume variation, pleth variability index

EXPERIMENTAL

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)

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

Interventions

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

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

stroke volume variation, pleth variability index

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 20
  • elective robot assisted thyroidectomy

You may not qualify if:

  • arrhythmia
  • BMI\>30
  • valvular heart disease
  • pul hypertension
  • peripheral artery occlusive disease
  • lung disease
  • right heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung-Ang University Hospital

Seoul, Seoul, 156-755, South Korea

RECRUITING

MeSH Terms

Interventions

Hydroxyethyl Starch Derivatives

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

Central Study Contacts

So-young Yang, clinical assistant professor

CONTACT

82-2-6299-3160didth79@hanmail.net

Yong-hun Jung, professor

CONTACT

82-2-6299-2579jyh623@cau.ac.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
So young Yang MD,PhD

Study Record Dates

First Submitted

April 22, 2014

First Posted

April 24, 2014

Study Start

April 1, 2014

Primary Completion

March 1, 2015

Last Updated

April 24, 2014

Record last verified: 2014-04

Locations

KR(1)