Anesthesia, Surgery
Conditions
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).
Interventions
DEVICEPulse 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.
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
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pulse Co-Oximeter Sensor All subjects are enrolled into this arm and will receive an investigational pulse CO-Oximeter sensors.
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. | 48 |
| Total | 48 |
Baseline characteristics
| Characteristic | Pulse Co-Oximeter Sensor |
|---|---|
| Age, Customized ≤ 18 years | 0 Participants |
| Age, Customized ≥ 65 years | 25 Participants |
| Age, Customized Between 18 and 65 years | 23 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 5 Participants |
| Race/Ethnicity, Customized White | 38 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 48 |
| other Total, other adverse events | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
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.
Time frame: approximately 2-6 hours during surgery
Population: Zero subjects were collected for validation as the study was terminated in the data collection phase due to slow enrollment