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Pleth Variability Index in Modified Prone Position or Knee-chest Position (Concord Position)

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ClinicalTrials.gov Identifier: NCT04002193
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Heesun Park, Asan Medical Center

Brief Summary:
To investigate whether PVI predicts the fluid responsiveness in modified prone position undergoing posterior approach cervical operation. Furthermore, modified prone position could influence on dynamic variables including stroke volume variation(SVV), pulse pressure variation(PPV) and PVI.

Condition or disease Intervention/treatment
Fluid Responsiveness Modified Prone Position Other: volume expansion

Detailed Description:

Objective :

To compare measurements of pleth variability index (PVI), pulse pressure variation (PPV) and stroke volume variation (SVV) to predict fluid responsiveness in modified prone position or knee-chest position (concord position) for cervical operation.

To identify Influence of the modified prone position (concord position) on these variables.

Method

  1. To assess influence of the position change on PVI and other variables(PPV, SVV)
  2. To assess PVI to predict fluid responsiveness at modified prone position

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pleth Variability Index as Predictors of Fluid Responsiveness in Modified Prone Position(Concord Position) or Knee-chest Position
Actual Study Start Date : December 6, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : March 31, 2021

Intervention Details:
  • Other: volume expansion
    To assess fluid responsiveness
    Other Name: If stroke volume of FloTrac® decrease 15 % of baseline, crystalloid loading of 4ml/kg will start.


Primary Outcome Measures :
  1. To assess influence of the position change on PVI and other variables(PPV, SVV) [ Time Frame: 1.supine position : 5 minute after anesthesia induction with arterial-line insertion 2. 5 min after crystalloid 4 ml/kg loading / 3. modified prone position (baseline) ]
    When position change from supine to modified prone position, to assess the change of PVI and other variables. The correlation of PVI and cardiac output during this change.


Secondary Outcome Measures :
  1. To measure dynamic variables (pulse pressure variation, stroke volume variation and pleth variability index) in modified prone position [ Time Frame: 1. Supine position : 5 minute after anesthesia induction with arterial-line insertion 2. 5 minute after a position change to prone 3. before and after fluid loading ]
    Record the data of variables after 5 minute hemodynamic stability without changes of drugs



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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients received cervical operation at modified prone position (concord position)
Criteria

Inclusion Criteria:

  • American Society of Anaesthesiologists'(ASA) physical status 1-3
  • patients who received cervical operation in modified prone position or knee-chest position

Exclusion Criteria:

  • Valvular heart disease
  • Congestive heart failure, reduced left ventricular function ( Ejection fraction < 40%)
  • Moderate grade of pulmonary disease
  • Arrhythmia (atrial fibrillation, atrial flutter.. etc.)
  • body mass index > 30 or < 15 kg/m2

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): NCT04002193


Contacts
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Contact: Asan Medical Center 82-02-3010-5606 heesunjuny@gmail.com
Contact: Asan Medical Center 82-02-3010-0649 koh9726@naver.com

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Wonuk Koh         
Sponsors and Collaborators
Asan Medical Center
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Responsible Party: Heesun Park, Clinical instructor of Anesthesiology and Pain department, Asan Medical Center
ClinicalTrials.gov Identifier: NCT04002193    
Other Study ID Numbers: HePark
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We did not have the permission of data share from institutional review board.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heesun Park, Asan Medical Center:
Pleth variability index