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

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.

Study Overview

• Status: Completed
• Conditions: Critically Ill Black Patients
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Gauteng
    • Soweto, Gauteng, South Africa
      • Chris Hani Baragwanath Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: non-invasive Haemaglobin; Measuring haemaglobin using non-invasive co-oximetry device	Other: non invasive co-oximetry haemaglobin measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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)	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.	during ICU admission

Collaborators and Investigators

• Sponsor: Chris Hani Baragwanath Academic Hospital
• Collaborators: Masimo Corporation

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: December 4, 2013
• First Submitted That Met QC Criteria: January 13, 2014
• First Posted (Estimate): January 14, 2014

Study Record Updates

• Last Update Posted (Estimate): August 16, 2016
• Last Update Submitted That Met QC Criteria: August 15, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: M120677