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Clinical Trials/NCT03120910
NCT03120910
Withdrawn
Not Applicable

Validation of PVI as a Parameter to Predict Fluid Responsiveness

Masimo Corporation1 site in 1 countryDecember 15, 2016
ConditionsAnesthesia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia
Sponsor
Masimo Corporation
Locations
1
Primary Endpoint
Clinical utility of PVI
Status
Withdrawn
Last Updated
5 years ago

Overview

Brief Summary

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).

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
December 15, 2016
End Date
February 9, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Clinical utility of PVI

Time Frame: 1-5 hours

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

Study Sites (1)

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