Continuous Non-Invasive SpHb and PVI Monitoring on Intra-Operative and Post-Surgical Clinical Outcomes

Terminated

• Conditions: Surgery
• Interventions: Device: In vivo SpHb and PVi Monitoring

• Registration Number: NCT02986789
• Lead Sponsor: Masimo Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-07
• Study First Posted: 2016-12-08
• Study Start: 2016-12-15
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Disposition First Submitted: 2019-09-18
• Disposition First Submitted QC: 2019-09-18
• Results First Submitted: 2021-09-16
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-10
• Last Update Submitted: 2021-12-10
• Results First Posted: 2022-01-05
• Disposition First Posted: 2022-01-05
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Evaluation Group	In vivo SpHb and PVi Monitoring	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.

Primary Outcome Measures

Name	Time	Method
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.