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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Fluid Responsiveness
• Modified Prone Position

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