Pleth Variability Index (PVI) to Predict Fluid Responsiveness

N/AWithdrawnNCT03120910

Masimo Corporation

Overview

Interventional data collection study to evaluate the ability of pleth variability index (PVI) to predict fluid responsiveness in comparison with other dynamic parameters including pulse pressure variation (PPV) and stroke volume variation (SVV).

No subjects were enrolled into the validation portion of this study.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Conditions

Anesthesia

Interventions

Pulse CO-Oximeter SensorDEVICE

Investigational Pulse Oximeter Sensor will measure hemoglobin (SpHb), pulse rate (PR), perfusion index (PI), pleth variability index (PVI), oxygen reserve index (ORI), etc.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age or older * Scheduled for elective surgery requiring general anesthesia and mechanical ventilation * Arterial line and Swan-Ganz catheter placement indicated as part of the scheduled surgical procedure Exclusion Criteria: * Patients with surgeries at or around site of sensor placement or skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish, or acrylic nails that would prevent monitoring of pulse-oximeter physiological parameters during the study * Patients with cardiac arrhythmias * Patients with intracardiac shunts

Locations (1)

UC Davis

Sacramento, California, United States

Outcomes

Primary Outcomes

Clinical utility of PVI

Correlation between PVI and SVV to assess PVI as a predictor for fluid responsiveness.

Time frame: 1-5 hours

Data from ClinicalTrials.gov

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