Comparison of Pulse Hemoglobin and Pleth Variability Index

Completed

Conditions studied: Anemia, Fluid Management

In brief

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.

Key facts

Study ID

NCT01602978

Run by

Loma Linda University

People needed

299

Starts

2010-02-01

Expected to finish

2018-02-13

Last updated by the study team

2019-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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