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NCT04002193 Clinical Trial

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

Fluid Responsiveness Clinical Trial

Official title:
Pleth Variability Index as Predictors of Fluid Responsiveness in Modified Prone Position(Concord Position) or Knee-chest Position

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04002193
Other study ID # HePark
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 6, 2019
Est. completion date October 31, 2020

Study information
Verified date March 2022
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date October 31, 2020
Est. primary completion date October 26, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years to 79 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• volume expansion
To assess fluid responsiveness

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul Songpa-gu

Sponsors (1)
Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess influence of the position change on PVI and other variables(PPV, SVV) 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. 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)
Secondary To measure dynamic variables (pulse pressure variation, stroke volume variation and pleth variability index) in modified prone position Record the data of variables after 5 minute hemodynamic stability without changes of drugs 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
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