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

Validation of Stroke Volume Variation and Pleth Variability Index as Predictors of Fluid Responsiveness in Patients Undergoing Robot Assisted Thyroidectomy

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.

Study Overview

• Status: Unknown
• Conditions: Thyroidectomy; Fluid Responsiveness
• Intervention / Treatment: Other: HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada)

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: So-young Yang, clinical assistant professor; Phone Number: 82-2-6299-3160; Email: didth79@hanmail.net
• Study Contact Backup: Name: Yong-hun Jung, professor; Phone Number: 82-2-6299-2579; Email: jyh623@cau.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-755
    • Recruiting
    • Chung-Ang University Hospital
    • Contact: Seong Deok Kim, MD.PhD; Phone Number: 82-2-6299-2571; Email: ksddeok@cau.ac.kr
    • Principal Investigator: So-young Yang, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Other: HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada); HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada) 6ml/kg of ideal body weight loading

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
stroke volume variation	5 minutes after volume replacement
pleth variability index	5 minutes after volume replacement

Collaborators and Investigators

• Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): March 1, 2015

Study Registration Dates

• First Submitted: April 22, 2014
• First Submitted That Met QC Criteria: April 23, 2014
• First Posted (Estimate): April 24, 2014

Study Record Updates

• Last Update Posted (Estimate): April 24, 2014
• Last Update Submitted That Met QC Criteria: April 23, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: Chung-Ang UH