Usefulness of Non-invasive Pulse Co-oximetry Haemaglobin Measurements in Critically Ill Black Patients
1 other identifier
interventional
149
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2013
CompletedFirst Posted
Study publicly available on registry
January 14, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedAugust 16, 2016
August 1, 2016
2.1 years
December 4, 2013
August 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
during ICU admission
Secondary Outcomes (4)
Time to result
during ICU admission
Cost of test
during ICU admission
Effect of skin pigmentation on result
during ICU admission
Effect of patients clinical state on test results.
during ICU admission
Study Arms (1)
non-invasive Haemaglobin
EXPERIMENTALMeasuring haemaglobin using non-invasive co-oximetry device
Interventions
Eligibility Criteria
You may qualify if:
- All patients with a condition that requires admission to ICU shall be considered to be eligible.
- Age 1month to 100years old
You may not qualify if:
- Patients under 1 month old
- Patients with an unrecordable blood pressure or body temperature \<34 degrees.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chris Hani Baragwanath Academic Hospitallead
- Masimo Corporationcollaborator
Study Sites (1)
Chris Hani Baragwanath Hospital
Soweto, Gauteng, South Africa
Related Publications (1)
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.
PMID: 29239951DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Paediatric Intensivist
Study Record Dates
First Submitted
December 4, 2013
First Posted
January 14, 2014
Study Start
February 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
August 16, 2016
Record last verified: 2016-08