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| Name | Class |
|---|---|
| Masimo Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | 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. | |
| SpHb Group. | Experimental | Continuous non-invasive hemoglobin monitoring (SpHb monitoring) was provided to the anesthesiologist to influence administration of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous non-invasive hemoglobin monitoring | Device | Anesthesiologist is provided with real-time continuous non-invasive hemoglobin monitoring to influence care provided to patient |
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During surgery (an average of about 4 hours) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wael N Awada, MD | Department of Anesthesia, ICU, and Pain Management, Cairo University, Egypt | Principal Investigator |
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Patients scheduled for neurosurgery
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Not Posted | 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. |
During surgery (an average of about 4 hours)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Wael N Awada | Cairo University School Of Medicine | 00201006481958 | waoool@hotmail.com |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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|
| During surgery (an average of about 4 hours) |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Not Posted |
| During surgery (an average of about 4 hours) |
| Primary | RBC Transfusions Per Subject Receiving a Transfusion | Determine whether using SpHb can affect the quantity of RBC transfused, per patient receiving a transfusion. | 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. | Posted | Mean | 95% Confidence Interval | units | During surgery (an average of about 4 hours) |
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| Primary | The Effect of SpHb on Transfusion Timeline | Length of time it takes to initiate a RBC transfusion after the need was first established. | 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. | Posted | Mean | 95% Confidence Interval | minutes | During surgery (an average of about 4 hours) |
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| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | 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. | 0 | 61 | 0 | 61 |
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