Comparison of Pulse Hemoglobin and Pleth Variability Index (Pleth)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01602978
Recruitment Status : Active, not recruiting
First Posted : May 21, 2012
Last Update Posted : February 5, 2018
Masimo Labs
Information provided by (Responsible Party):
Davinder Ramsingh, MD, Loma Linda University

Brief Summary:
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.

Condition or disease
Anemia Fluid Management

Study Type : Observational
Actual Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Pulse Hemoglobin and Pleth Variability Index to Standard Methods of Guiding Intraoperative Fluid and Transfusion Management During Major Surgical Procedures.
Study Start Date : February 2010
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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

Secondary Outcome Measures :
  1. Difference between measures compared to patient characteristics [ Time Frame: Start of surgery to end of surgery ]
    Secondary outcome measures are the size of difference between measures compared to patient characteristics.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01602978

United States, California
Loma Linda University
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Masimo Labs
Principal Investigator: Davinder Ramsingh, MD Loma Linda University

Responsible Party: Davinder Ramsingh, MD, Principal Investigator, Loma Linda University Identifier: NCT01602978     History of Changes
Other Study ID Numbers: 5100032
First Posted: May 21, 2012    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018