Anesthesia
Conditions
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.
Interventions
DEVICEPulse 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.
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical utility of PVI | 1-5 hours | Correlation between PVI and SVV to assess PVI as a predictor for fluid responsiveness. |
Countries
United States
Outcome results
None listed