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NCT03120910 Clinical Trial

Pleth Variability Index (PVI) to Predict Fluid Responsiveness

Anesthesia Clinical Trial

Official title:
Validation of PVI as a Parameter to Predict Fluid Responsiveness

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03120910
Other study ID # FLEM0005
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date December 15, 2016
Est. completion date February 9, 2018

Study information
Verified date December 2020
Source Masimo Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Description:

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

Other known NCT identifiers
  • NCT03075150

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 9, 2018
Est. primary completion date February 9, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States UC Davis Sacramento California

Sponsors (1)
Lead Sponsor Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical utility of PVI Correlation between PVI and SVV to assess PVI as a predictor for fluid responsiveness. 1-5 hours
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