Impact of SpHb Monitoring on Transfusion

Study Overview
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Brief Summary
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Continuous and noninvasive hemoglobin (SpHb) monitoring provides clinicians with real-time trending of changes or lack of changes in hemoglobin, which has the potential to alter red blood cell (RBC) transfusion decision making. The objective of this study was to evaluate the impact of SpHb monitoring on RBC transfusions in high blood loss surgery. The investigators hypothesize that SpHb will improve blood transfusion practice in the for of change the number of blood unit per patient and improve the outcome regards the time to take decision of transfusion trigger.

Detailed Description
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Eligible patients scheduled for neurosurgeries were enrolled into either a standard care group (Control Group) or an intervention group (SpHb Group). The Control Group received typical anesthesia care including estimated blood loss (EBL) assessment and intraoperative hemoglobin measurements from the central laboratory (Hb). Blood samples were taken when EBL was ≥15% of total blood volume. RBC transfusion was initiated if Hb was ≤10 g/dL and continued until the EBL was replaced and Hb >10g/dL was confirmed. The SpHb Group followed the same transfusion practice as the Control Group except the anesthesiologist was guided by the addition of SpHb monitoring with blood samples still taken pre- and post-transfusion. Additionally, the absolute and trend accuracy of SpHb compared to Hb was evaluated. Potential cost savings from reduced RBC utilization will be calculated if occured.

Official Title
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Continuous and Noninvasive Hemoglobin Monitoring Reduces Red Blood Cell Transfusion During Neurosurgery: A Prospective Cohort Study

Conditions
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Anemia

Intervention / Treatment
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* Device: Continuous non-invasive hemoglobin monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 1,2 patients from 15 to 60 years old scheduled for neurosurgical procedure Exclusion Criteria: Exclusion criteria included significant liver or renal disease, coagulopathy, pregnancy, anemia, and patients scheduled for procedures with excepted low blood loss.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL. | |
| Experimental: SpHb Group.<br>Continuous non-invasive hemoglobin monitoring (SpHb monitoring) was provided to the anesthesiologist to influence administration of care | Device: Continuous non-invasive hemoglobin monitoring<br>* Anesthesiologist is provided with real-time continuous non-invasive hemoglobin monitoring to influence care provided to patient<br>* Other names: Masimo Radical-7 with SpHb;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RBC Transfusions Per Subject Receiving a Transfusion | Determine whether using SpHb can affect the quantity of RBC transfused, per patient receiving a transfusion. | During surgery (an average of about 4 hours) | 
| The Effect of SpHb on Transfusion Timeline | Length of time it takes to initiate a RBC transfusion after the need was first established. | During surgery (an average of about 4 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SpHb Absolute and Trend Accuracy | To assess absolute accuracy, or single point comparison, paired SpHb and Hb measurements were compared pre- and post- transfusion and bias and standard deviation were calculated. A Bland Altman graph with limits of agreement (1.96 x standard deviation, adjusted for the bias) was plotted to show agreement across the range of values. To assess trending, a regression plot of changes in Hb and corresponding changes in SpHb was plotted and a coefficient of determination (R2) was calculated | During surgery (an average of about 4 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient safety, Anemia, Blood transfusion, non invasive hemoglobin monitoring