Comparison of Pulse Hemoglobin and Pleth Variability Index

NCT01602978 | Completed

• 1 other identifier: 5100032
• Study Type: observational
• Target: 299
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Fluid Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Difference between measures compared to patient characteristics

  Start of surgery to end of surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will be adults more than 18 years old that are scheduled for a major surgical procedure.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead
• Masimo Labs: collaborator

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Davinder Ramsingh, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: May 21, 2012
• Study Start: February 1, 2010
• Primary Completion: February 13, 2018
• Study Completion: February 13, 2018
• Last Updated: March 4, 2019

Record last verified: 2019-03

Locations

US (1)