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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01602978
Other study ID # 5100032
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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