Comparison of Pulse Hemoglobin and Pleth Variability Index

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01602978

Acronym

Pleth

Enrollment

299

Registered

2012-05-21

Start date

2010-02-28

Completion date

2018-02-13

Last updated

2019-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Fluid Management

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results