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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02986789
• Other study ID #: BIGT0001
• Status: Terminated
• Start date: December 15, 2016
• Est. completion date: August 31, 2018

Study information

• Verified date: December 2021
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• In vivo SpHb and PVi Monitoring
Pulse oximeter finger sensor that simultaneously monitors noninvasive hemoglobin (SpHb) and pleth variability index (PVi)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Masimo Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Approximately 6-8 hours