Usefulness of Non-invasive Pulse Co-oximetry Haemaglobin Measurements in Critically Ill Black Patients
Primary Purpose
Critically Ill Black Patients
Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
non invasive co-oximetry haemaglobin measurement
Sponsored by
About this trial
This is an interventional diagnostic trial for Critically Ill Black Patients
Eligibility Criteria
Inclusion Criteria:
- All patients with a condition that requires admission to ICU shall be considered to be eligible.
- Age 1month to 100years old
Exclusion Criteria:
- Patients under 1 month old
- Patients with an unrecordable blood pressure or body temperature <34 degrees.
Sites / Locations
- Chris Hani Baragwanath Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
non-invasive Haemaglobin
Arm Description
Measuring haemaglobin using non-invasive co-oximetry device
Outcomes
Primary Outcome Measures
Accuracy and precision of non invasive haemaglobin measurement.
Accuracy and precision of non invasive hemoglobin (Hb) measurement to invasive co-oximetry (blood gas analyser), and laboratory haemaglobin measurement.
For comparative purposes in our population (dark skinned patients, low Hb levels and during active transfusion) our outcome aim for Hb accuracy will be based on what Masimo has found previously in 11 335 comparisons. These are:
0.99g/dl at 1SD
Hb between 6g/dl and 12g/dl : 95% of readings within 2g/dl of laboratory value
Hb between 12g/dl and 18g/dl : 95% of readings within 2g/dl of laboratory value
Precision shall be described as a co-efficient of variation
Secondary Outcome Measures
Time to result
Time to result of non invasive hemoglobin (Hb) measurement compared to invasive co-oximetry (blood gas analyser), and laboratory haemaglobin measurement (Sysmex cell counter)
Cost of test
To compare the non invasive hemoglobin (Hb) measurement to invasive co-oximetry (blood gas analyser), and laboratory haemaglobin measurement (Sysmex cell counter) with regards to cost.
Effect of skin pigmentation on result
Effect of skin pigmentation on result of non invasive hemoglobin (Hb) measurement compared to to invasive co-oximetry (blood gas analyser), and laboratory haemaglobin measurement (Sysmex cell counter)
Effect of patients clinical state on test results.
Effect of patients clinical state on test results of non invasive hemoglobin (Hb) measurement compared to invasive co-oximetry (blood gas analyser), and laboratory haemaglobin measurement (Sysmex cell counter).
The effect of patients clinical state (temp, MAP, pH, Hb level, plethysmography index (PI), severity of illness score, presence of active transfusion, presence of active bleeding, use of pressors, use of other blood products) on test results (accuracy and precision) shall be evaluated.
Full Information
NCT ID
NCT02035306
First Posted
December 4, 2013
Last Updated
August 15, 2016
Sponsor
Chris Hani Baragwanath Academic Hospital
Collaborators
Masimo Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02035306
Brief Title
Usefulness of Non-invasive Pulse Co-oximetry Haemaglobin Measurements in Critically Ill Black Patients
Official Title
Usefulness of Non-invasive Pulse Co-oximetry Haemaglobin Measurements in Critically Ill Black Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chris Hani Baragwanath Academic Hospital
Collaborators
Masimo Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To answer the question whether a non-invasive haemaglobin measurement is clinically useful, reliable and accurate as compared to taking a blood sample and checking the haemaglobin level at the laboratory or in a blood gas analyser. This study will take place in a multi-disciplinary ICU of critically ill patients.
Detailed Description
A presenting sample of 150 patients requiring admission to ICU will be enrolled. These will include paediatric, trauma, adult medical and adult surgical patients. Informed consent will be obtained. Baseline demographic data, vital signs, Massey pigmentation score, and severity of illness scores will be calculated, as well as finger deformity, if present, nail polish or acrylics, smoking habits, finger diameter of finger measured, comorbidities and medications. Patients will be admitted in the usual way, and admission bloods will be sent to the laboratory as per usual protocol. Enrolled patients will in addition have their Haemaglobin and Plethysmography Index (measure of perfusion) measured non-invasively using the Masimo Pronto-7 handheld device. Note of concurrent medications, blood products and vital signs will be recorded at each measurement. Each patient will have measurements done 8 hourly (between 1-5 measurements per patient). Concurrent arterial blood gas samples will be taken in a heparinised syringe and performed on ABL radiometer blood gas analyser.. An additional EDTA blood sample shall be taken at each Pronto measuring point which will be measured at the laboratory on a Sysmex cell counter. Analysis of data will assess precision and accuracy, trend accuracy, and effect of pigmentation, vasopressors and other medication on the results of the non-invasive co-oximetry estimation of haemaglobin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill Black Patients
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
non-invasive Haemaglobin
Arm Type
Experimental
Arm Description
Measuring haemaglobin using non-invasive co-oximetry device
Intervention Type
Other
Intervention Name(s)
non invasive co-oximetry haemaglobin measurement
Primary Outcome Measure Information:
Title
Accuracy and precision of non invasive haemaglobin measurement.
Description
Accuracy and precision of non invasive hemoglobin (Hb) measurement to invasive co-oximetry (blood gas analyser), and laboratory haemaglobin measurement.
For comparative purposes in our population (dark skinned patients, low Hb levels and during active transfusion) our outcome aim for Hb accuracy will be based on what Masimo has found previously in 11 335 comparisons. These are:
0.99g/dl at 1SD
Hb between 6g/dl and 12g/dl : 95% of readings within 2g/dl of laboratory value
Hb between 12g/dl and 18g/dl : 95% of readings within 2g/dl of laboratory value
Precision shall be described as a co-efficient of variation
Time Frame
during ICU admission
Secondary Outcome Measure Information:
Title
Time to result
Description
Time to result of non invasive hemoglobin (Hb) measurement compared to invasive co-oximetry (blood gas analyser), and laboratory haemaglobin measurement (Sysmex cell counter)
Time Frame
during ICU admission
Title
Cost of test
Description
To compare the non invasive hemoglobin (Hb) measurement to invasive co-oximetry (blood gas analyser), and laboratory haemaglobin measurement (Sysmex cell counter) with regards to cost.
Time Frame
during ICU admission
Title
Effect of skin pigmentation on result
Description
Effect of skin pigmentation on result of non invasive hemoglobin (Hb) measurement compared to to invasive co-oximetry (blood gas analyser), and laboratory haemaglobin measurement (Sysmex cell counter)
Time Frame
during ICU admission
Title
Effect of patients clinical state on test results.
Description
Effect of patients clinical state on test results of non invasive hemoglobin (Hb) measurement compared to invasive co-oximetry (blood gas analyser), and laboratory haemaglobin measurement (Sysmex cell counter).
The effect of patients clinical state (temp, MAP, pH, Hb level, plethysmography index (PI), severity of illness score, presence of active transfusion, presence of active bleeding, use of pressors, use of other blood products) on test results (accuracy and precision) shall be evaluated.
Time Frame
during ICU admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients with a condition that requires admission to ICU shall be considered to be eligible.
Age 1month to 100years old
Exclusion Criteria:
Patients under 1 month old
Patients with an unrecordable blood pressure or body temperature <34 degrees.
Facility Information:
Facility Name
Chris Hani Baragwanath Hospital
City
Soweto
State/Province
Gauteng
Country
South Africa
12. IPD Sharing Statement
Citations:
PubMed Identifier
29239951
Citation
Murphy SM, Omar S. The Clinical Utility of Noninvasive Pulse Co-oximetry Hemoglobin Measurements in Dark-Skinned Critically Ill Patients. Anesth Analg. 2018 May;126(5):1519-1526. doi: 10.1213/ANE.0000000000002721.
Results Reference
derived
Learn more about this trial
Usefulness of Non-invasive Pulse Co-oximetry Haemaglobin Measurements in Critically Ill Black Patients
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