Anemia
Conditions
Keywords
Anemia, Blood transfusion, non invasive hemoglobin monitoring, patient safety
Brief summary
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
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.
Interventions
DEVICEContinuous non-invasive hemoglobin monitoring
Anesthesiologist is provided with real-time continuous non-invasive hemoglobin monitoring to influence care provided to patient
Sponsors
Masimo Corporation
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* ASA 1,2 patients from 15 to 60 years old scheduled for neurosurgical procedure
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RBC Transfusions Per Subject Receiving a Transfusion | During surgery (an average of about 4 hours) | Determine whether using SpHb can affect the quantity of RBC transfused, per patient receiving a transfusion. |
| The Effect of SpHb on Transfusion Timeline | During surgery (an average of about 4 hours) | Length of time it takes to initiate a RBC transfusion after the need was first established. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SpHb Absolute and Trend Accuracy | During surgery (an average of about 4 hours) | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Potential Cost Savings | During surgery (an average of about 4 hours) | Potential cost saving resulting from reduced RBC utilization was estimated using activity-based cost estimates established by Shander et al.(8) which determined from both U.S. and European hospitals the total cost of transfusing one RBC unit to be between $522 and $1,183 with a mean and standard deviation of $761 ± $294. |
Participant flow
Recruitment details
Patients scheduled for neurosurgery
Participants by arm
| Arm | Count |
|---|---|
| SpHb Group. In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.
Continuous non invasive hemoglobin monitoring arm
Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry | 45 |
| Control Group 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. | 61 |
| Total | 106 |
Baseline characteristics
| Characteristic | SpHb Group. | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 6 Participants | 6 Participants | 12 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 55 Participants | 94 Participants |
| Region of Enrollment Egypt | 45 participants | 61 participants | 106 participants |
| Sex: Female, Male Female | 25 Participants | 31 Participants | 56 Participants |
| Sex: Female, Male Male | 20 Participants | 30 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 61 |
| serious Total, serious adverse events | 0 / 45 | 0 / 61 |
Outcome results
Primary
RBC Transfusions Per Subject Receiving a Transfusion
Determine whether using SpHb can affect the quantity of RBC transfused, per patient receiving a transfusion.
Time frame: During surgery (an average of about 4 hours)
Population: We only included the participants who received a blood transfusion during the surgery for this analysis. Participants who did not receive a transfusion were excluded from this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SpHb Group. | RBC Transfusions Per Subject Receiving a Transfusion | 2.3 units |
| Control Group | RBC Transfusions Per Subject Receiving a Transfusion | 3.9 units |
p-value: <0.01t-test, 2 sided
Primary
The Effect of SpHb on Transfusion Timeline
Length of time it takes to initiate a RBC transfusion after the need was first established.
Time frame: During surgery (an average of about 4 hours)
Population: We only included the participants who received a blood transfusion during the surgery for this analysis. Participants who did not receive a transfusion were excluded from this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SpHb Group. | The Effect of SpHb on Transfusion Timeline | 9.2 minutes |
| Control Group | The Effect of SpHb on Transfusion Timeline | 50.2 minutes |
p-value: <0.001t-test, 2 sided
Secondary
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
Time frame: During surgery (an average of about 4 hours)
Other Pre-specified
Potential Cost Savings
Potential cost saving resulting from reduced RBC utilization was estimated using activity-based cost estimates established by Shander et al.(8) which determined from both U.S. and European hospitals the total cost of transfusing one RBC unit to be between $522 and $1,183 with a mean and standard deviation of $761 ± $294.
Time frame: During surgery (an average of about 4 hours)