Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Usefulness of Non-invasive Pulse Co-oximetry Haemaglobin Measurements in Critically Ill Black Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02035306
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : August 16, 2016
Sponsor:
Collaborator:
Masimo Corporation
Information provided by (Responsible Party):
Susan Murphy, Chris Hani Baragwanath Academic Hospital

Tracking Information
First Submitted Date  ICMJE December 4, 2013
First Posted Date  ICMJE January 14, 2014
Last Update Posted Date August 16, 2016
Study Start Date  ICMJE February 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2014)
Accuracy and precision of non invasive haemaglobin measurement. [ Time Frame: during ICU admission ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2014)
  • Time to result [ Time Frame: during ICU admission ]
    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 [ Time Frame: during ICU admission ]
    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 [ Time Frame: during ICU admission ]
    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. [ Time Frame: during ICU admission ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Usefulness of Non-invasive Pulse Co-oximetry Haemaglobin Measurements in Critically Ill Black Patients
Official Title  ICMJE Usefulness of Non-invasive Pulse Co-oximetry Haemaglobin Measurements in Critically Ill Black Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Critically Ill Black Patients
Intervention  ICMJE Other: non invasive co-oximetry haemaglobin measurement
Study Arms  ICMJE Experimental: non-invasive Haemaglobin
Measuring haemaglobin using non-invasive co-oximetry device
Intervention: Other: non invasive co-oximetry haemaglobin measurement
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2016)
149
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2014)
150
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02035306
Other Study ID Numbers  ICMJE M120677
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Susan Murphy, Chris Hani Baragwanath Academic Hospital
Study Sponsor  ICMJE Chris Hani Baragwanath Academic Hospital
Collaborators  ICMJE Masimo Corporation
Investigators  ICMJE Not Provided
PRS Account Chris Hani Baragwanath Academic Hospital
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP