Comparison of Pulse Hemoglobin and Pleth Variability Index

This study is currently recruiting participants.
Verified March 2014 by Loma Linda University
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: March 10, 2014
Last verified: March 2014

March 1, 2012
March 10, 2014
February 2010
January 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01602978 on ClinicalTrials.gov Archive Site
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.
Same as current
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Comparison of Pulse Hemoglobin and Pleth Variability Index
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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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

  • Anemia
  • Fluid Management
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Carl Collier, DO 909-558-8493 ccollier@llu.edu
Contact: Patricia Moore, Coordinator 909-558-8493 pamoore@llu.edu
United States
 
NCT01602978
5100032
No
Richard Applegate, Loma Linda University
Loma Linda University
Masimo Labs
Principal Investigator: Carl Collier, DO Loma Linda University
Loma Linda University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP