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OpenTrials
Completed

NCT Number: NCT04002193

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

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.

Completed

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Key information

Conditions

Fluid Responsiveness Modified Prone Position

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, Songpa-gu, South Korea

About this study

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

volume expansion

Other

To assess fluid responsiveness

Other names: If stroke volume of FloTrac® decrease 15 % of baseline, crystalloid loading of 4ml/kg will start.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 28, 2019
Registry last updated
Mar 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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