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

Thyroidectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02122367
• Other study ID #: Chung-Ang UH
• Status: Recruiting
• Phase: Phase 4
• First received: April 22, 2014
• Last updated: April 23, 2014
• Start date: April 2014

Study information

• Verified date: April 2014
• Source: Chung-Ang University Hospital
• Contact: So-young Yang, clinical assistant professor
• Phone: 82-2-6299-3160
• Email: didth79[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fluid Responsiveness
• Thyroidectomy

Intervention

Other:
• HES 130/0.4 (Volulyte?, Fresenius Kabi, Canada)
HES 130/0.4 (Volulyte?, Fresenius Kabi, Canada) 6ml/kg of ideal body weight loading

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chung-Ang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stroke volume variation		5 minutes after volume replacement	No
Primary	pleth variability index		5 minutes after volume replacement	No