Validation of RPVi as a Parameter to Predict Fluid Responsiveness

Terminated

• Conditions: Surgery; Anesthesia
• Interventions: Device: Pulse CO-Oximeter sensor

• Registration Number: NCT03706430
• Lead Sponsor: Masimo Corporation

Brief Summary

This is a prospective, nonrandomized, sequential data collection study to evaluate the ability of RPVi to predict fluid responsiveness in comparison with other dynamic parameters including stroke volume variation (SVV) and/or pulse pressure variation (PPV).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-24
• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-11
• Study First Posted: 2018-10-16
• Primary Completion: 2021-10-20
• Study Completion: 2021-10-20
• Results First Submitted: 2023-01-23
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-30
• Last Update Submitted: 2023-05-30
• Results First Posted: 2023-06-22
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• 18 years of age or older at the time of consent
• Scheduled for elective surgery requiring general anesthesia and mechanical ventilation
• Arterial line and other standard of care line placement indicated as part of the scheduled surgical procedure

Exclusion Criteria

• Patients diagnosed with or history of heart failure, angina, pulmonary heart disease, rheumatic heart disease, cardiomyopathy, congenital heart disease, or valvular heart disease.
• Patients scheduled for or has had a liver transplant
• 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: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Pulse Co-Oximeter sensor	Pulse CO-Oximeter sensor	All subjects are enrolled into this arm and will receive an investigational pulse CO-Oximeter sensors.

Primary Outcome Measures

Name	Time	Method
Comparison of RPVi to SVV and/or PPV	approximately 2-6 hours during surgery	To evaluate the ability of RPVi to predict fluid responsiveness in comparison with other dynamic parameters including Stroke Volume Variation (SVV) and/or Pulse Pressure Variation (PPV) using Bland Altman analysis.

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States