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

Completed

• Conditions: Fluid Responsiveness; Modified Prone Position

• Registration Number: NCT04002193
• Lead Sponsor: 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.

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

Study Timeline

• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-06-27
• Study First Posted: 2019-06-28
• Study Start: 2019-12-06
• Primary Completion: 2020-10-26
• Study Completion: 2020-10-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-23
• Last Update Posted: 2022-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess influence of the position change on PVI and other variables(PPV, SVV)	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

Name	Time	Method
To measure dynamic variables (pulse pressure variation, stroke volume variation and pleth variability index) in modified prone position	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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of