Anesthesia Clinical Trial
Official title:
Validation of PVI as a Parameter to Predict Fluid Responsiveness
Verified date | December 2020 |
Source | Masimo Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
United States | UC Davis | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
Masimo Corporation |
United States,
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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