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

NCT02986789 | Terminated Results

• 1 other identifier: BIGT0001
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Approximately 6-8 hours

Study Arms (2)

Control Group

NO INTERVENTION

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

Evaluation Group

EXPERIMENTAL

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.

Device: In vivo SpHb and PVi Monitoring

Interventions

In vivo SpHb and PVi Monitoring DEVICE

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

Evaluation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Masimo Corporation: lead

Results Point of Contact

• Title: Cristina Johnson
• Organization: Masimo Corporation

clinicalresearchdept@masimo.com

949-297-7000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: December 15, 2016
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: November 12, 2025
• Results First Posted: January 5, 2022

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share