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Comparison of Pulse Hemoglobin and Pleth Variability Index

Loma Linda University (LLU) logo

Loma Linda University (LLU)

Status

Completed

Conditions

Anemia
Fluid Management

Study type

Observational

Funder types

Other

Identifiers

NCT01602978
5100032

Details and patient eligibility

About

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.

Enrollment

299 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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