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Completed

NCT Number: NCT01602978

Comparison of Pulse Hemoglobin and Pleth Variability Index

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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Key information

Conditions

Anemia Fluid Management Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Loma Linda University

Loma Linda, California, 92354, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Collaborators

  • Masimo Labs

Registry information

Official study title

Comparison of Pulse Hemoglobin and Pleth Variability Index to Standard Methods of Guiding Intraoperative Fluid and Transfusion Management During Major Surgical Procedures.

Acronym: Pleth

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
May 21, 2012
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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