Comparison of Pulse Hemoglobin and Pleth Variability Index
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Richard Applegate, Loma Linda University
First received: March 1, 2012
Last updated: September 23, 2014
Last verified: September 2014
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Comparison of Pulse Hemoglobin and Pleth Variability Index to Standard Methods of Guiding Intraoperative Fluid and Transfusion Management During Major Surgical Procedures.
Primary Outcome Measures:
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2015 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
The study population will be adults more than 18 years old that are scheduled for a major surgical procedure.
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602978
|Loma Linda University
|Loma Linda, California, United States, 92354 |
Loma Linda University
||Carl Collier, DO
||Loma Linda University
No publications provided
ClinicalTrials.gov processed this record on November 25, 2014
||Richard Applegate, Principal Investigator, Loma Linda University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 1, 2012
||September 23, 2014
||United States: Institutional Review Board