Comparison of Pulse Hemoglobin and Pleth Variability Index (Pleth)

Comparison of Pulse Hemoglobin and Pleth Variability Index to Standard Methods of Guiding Intraoperative Fluid and Transfusion Management During Major Surgical Procedures.

The purpose of this study is to investigate whether a validated sensor that is able to measure how much oxygen-carrying molecules called hemoglobin using pulse hemoglobin and Pleth Variability Index (PVI)] are in your blood during surgery can help your doctors manage how much fluid and possibly blood you need to get during your surgery. The hope of the study is that the device may provide an early indication you are having bleeding and this may mean you need to be treated with a transfusion. Our current method of checking this is by getting a blood sample for analysis. The investigators hope is that this device may be able to alert the clinician of the need for blood or fluids without a blood draw being needed.

Study Overview

• Status: Completed
• Conditions: Anemia; Fluid Management

• Study Type: Observational
• Enrollment (Actual): 299

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population will be adults more than 18 years old that are scheduled for a major surgical procedure.

Description

Inclusion Criteria:

• Subjects must be >18 years old;
• must be having a major surgical procedure;
• The pre-operative estimation of blood loss must be at least 15% of the total blood volume

Exclusion Criteria:

• Does subject have hemoglobinopathy;
• cardiac arrhythmias producing irregular rhythms;
• severe pulmonary disease;
• procedures where loss of more that 10 to 15% of total blood volume is unlikely;
• subject refusal

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference between hemoglobin values from the two monitors.	The primary outcome measure is the difference between hemoglobin values from the pulse oximetry device and from the arterial blood gas co-oximeter.	Pulse hemoglobin will be monitored during the surgery from the first arterial blood gas drawn to the last ABG drawn.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between measures compared to patient characteristics	Secondary outcome measures are the size of difference between measures compared to patient characteristics.	Start of surgery to end of surgery

Collaborators and Investigators

• Sponsor: Loma Linda University
• Collaborators: Masimo Labs

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): February 13, 2018
• Study Completion (ACTUAL): February 13, 2018

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: May 17, 2012
• First Posted (ESTIMATE): May 21, 2012

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2019
• Last Update Submitted That Met QC Criteria: March 1, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 5100032