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

NCT ID: NCT02986789

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-15
• Study Completion Date: 2018-08-31

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.

Conditions

Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control Group

Clinicians will be performing blood transfusions using hospital standard of care procedures.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

In vivo SpHb and PVi Monitoring

Intervention Type: DEVICE

Pulse oximeter finger sensor that simultaneously monitors noninvasive hemoglobin (SpHb) and pleth variability index (PVi)

Interventions

In vivo SpHb and PVi Monitoring

Pulse oximeter finger sensor that simultaneously monitors noninvasive hemoglobin (SpHb) and pleth variability index (PVi)

Intervention Type: DEVICE

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masimo Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BIGT0001

Identifier Type: -

Identifier Source: org_study_id