Validation of RPVi as a Parameter to Predict Fluid Responsiveness

Surgery Clinical Trial

Official title:

Validation of RPVi as a Parameter to Predict Fluid Responsiveness

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03706430
• Other study ID #: CANN0011
• Status: Terminated
• Start date: September 24, 2018
• Est. completion date: October 20, 2021

Study information

• Verified date: May 2023
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. completion date: October 20, 2021
• Est. primary completion date: October 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Surgery

Intervention

Device:
• Pulse CO-Oximeter sensor
Investigational Pulse CO-Oximeter sensor will measure hemoglobin (SpHb), Pulse Rate (PR), Perfusion Index (Pi), Methemoglobin (SpMet), Pleth Variability Index (PVi), RPVi, etc.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of RPVi to SVV and/or PPV	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.	approximately 2-6 hours during surgery