Pleth Variability Index (PVI) to Predict Fluid Responsiveness
Not Applicable
Withdrawn
- Conditions
- Anesthesia
- Interventions
- Device: Pulse CO-Oximeter Sensor
- Registration Number
- NCT03120910
- Lead Sponsor
- Masimo Corporation
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Test Subjects Pulse CO-Oximeter Sensor All subjects are enrolled into this arm and will receive an investigational pulse CO-Oximeter sensor, including nasal sensors, with the same or similar technology and materials as the Masimo FDA cleared devices and sensors.
- Primary Outcome Measures
Name Time Method Clinical utility of PVI 1-5 hours Correlation between PVI and SVV to assess PVI as a predictor for fluid responsiveness.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UC Davis
🇺🇸Sacramento, California, United States