Evaluation of Impacts of Continuous Non-Invasive Intra-Operative Hemoglobin and PVI Monitoring on Intra-Operative and Post-Surgical Clinical Outcomes

Masimo Corporation0 sites43 target enrollmentDecember 15, 2016

ConditionsSurgery

Overview

Phase: N/A
Intervention: Not specified
Conditions: Surgery
Sponsor: Masimo Corporation
Enrollment: 43
Primary Endpoint: Average Volume of Allogenic RBC Transfused Intra-operatively
Status: Terminated
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 15, 2016

End Date

August 31, 2018

Last Updated

5 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Masimo Corporation

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Average Volume of Allogenic RBC Transfused Intra-operatively

Time Frame: 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.