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

Phase 4

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

• Registration Number: NCT02122367
• Lead Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-04
• Study Start: 2014-04
• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-23
• Last Update Submitted: 2014-04-23
• Study First Posted: 2014-04-24
• Last Update Posted: 2014-04-24
• Primary Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stroke volume variation, pleth variability index	HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada)	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)

Primary Outcome Measures

Name	Time	Method
stroke volume variation	5 minutes after volume replacement
pleth variability index	5 minutes after volume replacement

Trial Locations

Locations (1)

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of