Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 3 of 146 for:    Open Studies | "African Americans"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Chris Hani Baragwanath Academic Hospital
Sponsor:
Collaborator:
Masimo Corporation
Information provided by (Responsible Party):
Susan Murphy, Chris Hani Baragwanath Academic Hospital
ClinicalTrials.gov Identifier:
NCT02035306
First received: December 4, 2013
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Critically Ill Black Patients
Other: non invasive co-oximetry haemaglobin measurement

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Usefulness of Non-invasive Pulse Co-oximetry Haemaglobin Measurements in Critically Ill Black Patients

Further study details as provided by Chris Hani Baragwanath Academic Hospital:

Primary Outcome Measures:
  • Accuracy and precision of non invasive haemaglobin measurement. [ Time Frame: during ICU admission ] [ Designated as safety issue: No ]

    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 Frame: during ICU admission ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 150
Study Start Date: February 2014
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: non-invasive Haemaglobin
Measuring haemaglobin using non-invasive co-oximetry device
Other: non invasive co-oximetry haemaglobin measurement

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.

  Eligibility

Ages Eligible for Study:   1 Month and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02035306

Locations
South Africa
Chris Hani Baragwanath Hospital Not yet recruiting
Soweto, Gauteng, South Africa
Contact: Susan M Murphy, MBBCh, FCPaed, Crit Care(SA)    +27 9330270    Susan.Murphy@wits.ac.za   
Sponsors and Collaborators
Chris Hani Baragwanath Academic Hospital
Masimo Corporation
  More Information

No publications provided

Responsible Party: Susan Murphy, Paediatric Intensivist, Chris Hani Baragwanath Academic Hospital
ClinicalTrials.gov Identifier: NCT02035306     History of Changes
Other Study ID Numbers: M120677
Study First Received: December 4, 2013
Last Updated: January 13, 2014
Health Authority: South Africa: university human research ethics committee (medical)

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014