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

Chris Hani Baragwanath Academic Hospital

Status: Completed

Conditions: Critically Ill Black Patients

Treatments: Other: non invasive co-oximetry haemaglobin measurement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02035306

M120677

Details and patient eligibility

About

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.

Full 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.

Enrollment: 149 patients

Sex: All

Ages: 1 month to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

149 participants in 1 patient group

non-invasive Haemaglobin

Experimental group

Description:

Measuring haemaglobin using non-invasive co-oximetry device

Treatment:

Other: non invasive co-oximetry haemaglobin measurement