Critically Ill Black PatientsNCT02035306
Usefulness of Non-invasive Pulse Co-oximetry Haemaglobin Measurements in Critically Ill Black Patients
A study testing non invasive co-oximetry haemaglobin measurement in people with Critically Ill Black Patients, run by Chris Hani Baragwanath Academic Hospital at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 100 years
- Conditions the study is for
- Critically Ill Black Patients
- What is being tested?
- non invasive co-oximetry haemaglobin measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteSouth Africa
- Study dates
- Feb 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with a condition that requires admission to ICU shall be considered to be eligible.
- Age 1month to 100years old
Who cannot join
- Patients under 1 month old
- Patients with an unrecordable blood pressure or body temperature <34 degrees.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Critically Ill Black Patients
- Being tested
- non invasive co-oximetry haemaglobin measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non invasive co-oximetry haemaglobin measurementOther
| Study group | Role | What they receive |
|---|---|---|
| non-invasive Haemaglobin | Experimental | Measuring haemaglobin using non-invasive co-oximetry device Receives: Other: non invasive co-oximetry haemaglobin measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during ICU admission
Secondary outcomes (4)
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)
Measured: during ICU admission
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.
Measured: during ICU admission
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)
Measured: during ICU admission
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.
Measured: during ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critically Ill Black PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chris Hani Baragwanath Academic Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Masimo Corporation
- Responsible party
- Principal investigator, Susan Murphy, Chris Hani Baragwanath Academic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035306
- Sponsor's protocol ID
- M120677
- Status last verified
- Aug 2016
- First submitted
- 4 Dec 2013
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29239951
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Non-invasive Pulse Co-oximetry Haemaglobin Measurements in Critically Ill Black Patients
- ClinicalTrials.gov ID
- NCT02035306
- Acronym / sponsor ID
- M120677
- Conditions
- Critically Ill Black Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Chris Hani Baragwanath Academic HospitalUniversity, hospital or other
- Collaborators
- Masimo Corporation
- Study start
- Feb 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-invasive Haemaglobin | Experimental | Other: non invasive co-oximetry haemaglobin measurementMeasuring haemaglobin using non-invasive co-oximetry device |
Who may qualify
- Ages
- 1 month to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All patients with a condition that requires admission to ICU shall be considered to be eligible.
- Age 1month to 100years old
Key exclusion criteria (2 listed)
- Patients under 1 month old
- Patients with an unrecordable blood pressure or body temperature <34 degrees.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non invasive co-oximetry haemaglobin measurement | Other | non-invasive Haemaglobin |
Primary outcome
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
4 secondary outcomes
Time to result
Time frame: during ICU admission
Cost of test
Time frame: during ICU admission
Effect of skin pigmentation on result
Time frame: during ICU admission
Effect of patients clinical state on test results.
Time frame: during ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Derived from this study: PubMed 29239951Murphy 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non invasive co-oximetry haemaglobin measurement in people with Critically Ill Black Patients, run by Chris Hani Baragwanath Academic Hospital at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy and precision of non invasive haemaglobin measurement. (time frame: during ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02035306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.