PVI for TVC Response

The Effectiveness of Tidal Volume Challenge Incorporating Plethysmographic Variability Index in Predicting Fluid Responsiveness

Determine the ability of changes in Plethysmographic Variability Index during tidal volume challenge to predict fluid responsiveness

Study Overview

• Status: Recruiting
• Conditions: Validation of PVI in Tidal Volume Challenge Test

Detailed Description

The change of Plethysmographic Variability Index after tidal volume challenge as a predictor of fluid responsiveness, confirmed with the change of SVV using Flotrac advance cardiac output monitor.

To determine whether the patient is fluid responder, Fluid challenge will be performed afterwards to confirm the patient's fluid responsiveness.

We also aim to calculate the least significant change for Plethysmographic Variability Index and Philips PPV system.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective major surgery (estimated > 2-hr) with general anesthesia and mechanical ventilation in supine position

Description

Inclusion:

Patients undergoing elective major surgery (estimated > 2-hr) with general anesthesia and mechanical ventilation in supine position

Exclusion:

1. BMI < 18.5 or >30 kg/m2
2. Pregnant patient
3. Allergy to starch solution
4. estimated glomerular filtration rate< 60

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The predictive ability of change in Plethysmographic Variability Index after Tidal volume challenge to predict fluid responsiveness	The change in value of Plethysmographic Variability Index after increasing VTE from 6 ml/kg to 8 ml/kg.	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Least significant change for Massimo PVI and Philips PPV	Calculate the least significant change for Massimo PVI and Philips PPV using data acquired from our electronic system	20 minutes

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: July 18, 2021
• First Submitted That Met QC Criteria: July 18, 2021
• First Posted (Actual): July 27, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 18, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: tidal volume challenge,Plethysmography variability index,Fluid responsiveness
• Other Study ID Numbers: 202104002RINC