Comparison of Pulse Hemoglobin and Pleth Variability Index

Completed

• Conditions: Anemia; Fluid Management

• Registration Number: NCT01602978
• Lead Sponsor: Loma Linda University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-05-17
• Study First Posted: 2012-05-21
• Primary Completion: 2018-02-13
• Study Completion: 2018-02-13
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-01
• Last Update Posted: 2019-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference between hemoglobin values from the two monitors.	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 Outcome Measures

Name	Time	Method
Difference between measures compared to patient characteristics	Start of surgery to end of surgery	Secondary outcome measures are the size of difference between measures compared to patient characteristics.

Trial Locations

Locations (1)

Loma Linda University; 🇺🇸 Loma Linda, California, United States