Comparison of Pulse Hemoglobin and Pleth Variability Index

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Masimo Labs
Information provided by (Responsible Party):
Richard Applegate, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01602978
First received: March 1, 2012
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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
Anemia
Fluid Management

Study Type: Observational
Study Design: 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.

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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:
  • Difference between measures compared to patient characteristics [ Time Frame: Start of surgery to end of surgery ] [ Designated as safety issue: No ]
    Secondary outcome measures are the size of difference between measures compared to patient characteristics.


Estimated Enrollment: 240
Study Start Date: February 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602978

Locations
United States, California
Loma Linda University
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Masimo Labs
Investigators
Principal Investigator: Carl Collier, DO Loma Linda University
  More Information

No publications provided

Responsible Party: Richard Applegate, Principal Investigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT01602978     History of Changes
Other Study ID Numbers: 5100032
Study First Received: March 1, 2012
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014