Surgery
Conditions
Brief summary
The study evaluates the use of noninvasive hemoglobin with In Vivo feature and PVi monitoring using pulse-oximetry based technologies and their effect on the management of transfusion and infusion decisions and clinical outcomes for the surgical patient.
Interventions
DEVICEIn vivo SpHb and PVi Monitoring
Pulse oximeter finger sensor that simultaneously monitors noninvasive hemoglobin (SpHb) and pleth variability index (PVi)
Sponsors
Masimo Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients undergoing major surgeries associated with possibility of significant blood loss (e.g. such that blood is cross-matched and available before the start of the case as per hospital routine practice) under general anesthesia. * At least one finger available and accessible for performing non-invasive hemoglobin monitoring.
Exclusion criteria
* Patient has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent the proper fit and application of the sensors * Procedures performed using robotics surgery * Any patients with a known hemoglobinopathy * Any patients undergoing Cardio-Pulmonary Bypass (CPB) * Any patients who cannot be transfused or has refused consent for a blood transfusion * Patients being treated by any artificial oxygen carriers within 30 days of hospital stay * Patients being managed outside of an operating room in the participating centers, or in operating room with conditions not conducive to perform and complete the study procedures (including use of the hemoglobin monitoring device) * Patients younger than 18 years old * Patients who are pregnant * Patients with cardiac arrhythmia * Patients with tidal volume setting \< 6ml/kg * Patients with PEEP \>= 10cm H2O * Patients undergoing cardiac and/or any open chest procedures * Emergency patients due to the foreseeable difficulty in consenting * Patients deemed not suitable for study at the discretion of the Principal Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Volume of Allogenic RBC Transfused Intra-operatively | Approximately 6-8 hours | Reduction in overall allogenic transfusion is defined as the decrease in volume of transfusion of the intervention group relative to control group, intra-operatively. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Clinicians will be performing blood transfusions using hospital standard of care procedures. | 43 |
| Evaluation Group Clinicians will be guiding blood transfusions using SpHb with In vivo feature as a trigger for laboratory blood draws and PVi to inform fluid administration decisions in addition to hospital standard of care procedures.
In vivo SpHb and PVi Monitoring: Pulse oximeter finger sensor that simultaneously monitors noninvasive hemoglobin (SpHb) and pleth variability index (PVi) | 0 |
| Total | 43 |
Baseline characteristics
| Characteristic | Control Group | Evaluation Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 0 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 0 Participants | 29 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants | 0 Participants | 9 Participants |
| Race/Ethnicity, Customized Hispanic, Latino, or Spanish origin | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White or Caucasian | 32 Participants | 0 Participants | 32 Participants |
| Region of Enrollment United States | 43 participants | — | 43 participants |
| Sex: Female, Male Female | 22 Participants | 0 Participants | 22 Participants |
| Sex: Female, Male Male | 21 Participants | 0 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 0 |
| other Total, other adverse events | 0 / 43 | 0 / 0 |
| serious Total, serious adverse events | 0 / 43 | 0 / 0 |
Outcome results
Primary
Average Volume of Allogenic RBC Transfused Intra-operatively
Reduction in overall allogenic transfusion is defined as the decrease in volume of transfusion of the intervention group relative to control group, intra-operatively.
Time frame: Approximately 6-8 hours
Population: Only historical chart review was able to be completed for the 43 control subjects, therefore there are no results to report for the control group. This study was not able to meet the enrollment target for the control and intervention groups, and therefore average volume of allogenic RBC transfused intra-operatively could not be defined (primary outcome measures).