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

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ClinicalTrials.gov Identifier: NCT02122367
Recruitment Status : Unknown
Verified April 2014 by So Young Yang, Chung-Ang University Hosptial, Chung-Ang University College of Medicine.
Recruitment status was:  Recruiting
First Posted : April 24, 2014
Last Update Posted : April 24, 2014
Sponsor:
Information provided by (Responsible Party):
So Young Yang, 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.

Condition or disease Intervention/treatment Phase
Thyroidectomy Fluid Responsiveness Other: HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada) Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of Stroke Volume Variation and Pleth Variability Index as Predictors of Fluid Responsiveness in Patients Undergoing Robot Assisted Thyroidectomy
Study Start Date : April 2014
Estimated Primary Completion Date : March 2015

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




Primary Outcome Measures :
  1. stroke volume variation [ Time Frame: 5 minutes after volume replacement ]
  2. pleth variability index [ Time Frame: 5 minutes after volume replacement ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02122367


Contacts
Contact: So-young Yang, clinical assistant professor 82-2-6299-3160 didth79@hanmail.net
Contact: Yong-hun Jung, professor 82-2-6299-2579 jyh623@cau.ac.kr

Locations
Korea, Republic of
Chung-Ang University Hospital Recruiting
Seoul, Korea, Republic of, 156-755
Contact: Seong Deok Kim, MD.PhD    82-2-6299-2571    ksddeok@cau.ac.kr   
Principal Investigator: So-young Yang, MD,PhD         
Sponsors and Collaborators
Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Responsible Party: So Young Yang, So young Yang MD,PhD, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
ClinicalTrials.gov Identifier: NCT02122367     History of Changes
Other Study ID Numbers: Chung-Ang UH
First Posted: April 24, 2014    Key Record Dates
Last Update Posted: April 24, 2014
Last Verified: April 2014