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

• ClinicalTrials.gov Identifier: NCT02035306
• Recruitment Status: Completed
• First Posted: January 14, 2014
• Last Update Posted: August 16, 2016
• Sponsor: Chris Hani Baragwanath Academic Hospital
• Collaborator: Masimo Corporation
• Information provided by (Responsible Party): Susan Murphy, Chris Hani Baragwanath Academic Hospital

Tracking Information

• First Submitted Date: December 4, 2013
• First Posted Date: January 14, 2014
• Last Update Posted Date: August 16, 2016
• Study Start Date: February 2014
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Critically Ill Black Patients
• Intervention: Other: non invasive co-oximetry haemaglobin measurement

Study Arms

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 15, 2016): 149
• Original Estimated Enrollment (submitted: January 13, 2014): 150
• Actual Study Completion Date: March 2016
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Month to 100 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: South Africa

Administrative Information

• NCT Number: NCT02035306
• Other Study ID Numbers: M120677
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Susan Murphy, Chris Hani Baragwanath Academic Hospital
• Study Sponsor: Chris Hani Baragwanath Academic Hospital
• Collaborators: Masimo Corporation
• Investigators: Not Provided
• PRS Account: Chris Hani Baragwanath Academic Hospital
• Verification Date: August 2016