Pleth Variability Index (PVI) to Predict Fluid Responsiveness

Masimo

Status: Withdrawn

Conditions: Anesthesia

Treatments: Device: Pulse CO-Oximeter Sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03120910

FLEM0005

Details and patient eligibility

About

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).

Full description

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

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Test Subjects

Experimental group

Description:

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.

Treatment:

Device: Pulse CO-Oximeter Sensor