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Impact of SpHb Monitoring on Transfusion

Primary Purpose

Anemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Continuous non-invasive hemoglobin monitoring
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anemia focused on measuring Anemia, Blood transfusion, non invasive hemoglobin monitoring, patient safety

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control Group

    SpHb Group.

    Arm Description

    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.

    Continuous non-invasive hemoglobin monitoring (SpHb monitoring) was provided to the anesthesiologist to influence administration of care

    Outcomes

    Primary Outcome Measures

    RBC Transfusions Per Subject Receiving a Transfusion
    Determine whether using SpHb can affect the quantity of RBC transfused, per patient receiving a transfusion.
    The Effect of SpHb on Transfusion Timeline
    Length of time it takes to initiate a RBC transfusion after the need was first established.

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    July 13, 2013
    Last Updated
    January 24, 2014
    Sponsor
    Cairo University
    Collaborators
    Masimo Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01906515
    Brief Title
    Impact of SpHb Monitoring on Transfusion
    Official Title
    Continuous and Noninvasive Hemoglobin Monitoring Reduces Red Blood Cell Transfusion During Neurosurgery: A Prospective Cohort Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2012 (undefined)
    Primary Completion Date
    October 2012 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University
    Collaborators
    Masimo Corporation

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia
    Keywords
    Anemia, Blood transfusion, non invasive hemoglobin monitoring, patient safety

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    106 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    SpHb Group.
    Arm Type
    Experimental
    Arm Description
    Continuous non-invasive hemoglobin monitoring (SpHb monitoring) was provided to the anesthesiologist to influence administration of care
    Intervention Type
    Device
    Intervention Name(s)
    Continuous non-invasive hemoglobin monitoring
    Other Intervention Name(s)
    Masimo Radical-7 with SpHb
    Intervention Description
    Anesthesiologist is provided with real-time continuous non-invasive hemoglobin monitoring to influence care provided to patient
    Primary Outcome Measure Information:
    Title
    RBC Transfusions Per Subject Receiving a Transfusion
    Description
    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)
    Title
    The Effect of SpHb on Transfusion Timeline
    Description
    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)
    Secondary Outcome Measure Information:
    Title
    SpHb Absolute and Trend Accuracy
    Description
    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 Outcome Measures:
    Title
    Potential Cost Savings
    Description
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wael N Awada, MD
    Organizational Affiliation
    Department of Anesthesia, ICU, and Pain Management, Cairo University, Egypt
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Impact of SpHb Monitoring on Transfusion

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