Comparison of Pulse Hemoglobin and Pleth Variability Index

Anemia Clinical Trial

— Pleth  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01602978
• Other study ID #: 5100032
• Status: Completed
• Start date: February 2010
• Est. completion date: February 13, 2018

Study information

• Verified date: March 2019
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: February 13, 2018
• Est. primary completion date: February 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Fluid Management

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Loma Linda University	Masimo Labs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference between hemoglobin values from the two monitors.	The primary outcome measure is the difference between hemoglobin values from the pulse oximetry device and from the arterial blood gas co-oximeter.	Pulse hemoglobin will be monitored during the surgery from the first arterial blood gas drawn to the last ABG drawn.
Secondary	Difference between measures compared to patient characteristics	Secondary outcome measures are the size of difference between measures compared to patient characteristics.	Start of surgery to end of surgery