Non-invasive haemoglobin measurement in patients undergoing elective Caesarean section

Area of Science:

• Obstetrics and Gynecology
• Medical Devices
• Clinical Chemistry

Background:

• Real-time, non-invasive haemoglobin (Hb) measurement is clinically valuable for assessing peripartum maternal Hb changes.
• This study investigates the Masimo Rainbow SET(®) Radical-7 Pulse CO-Oximeter's performance in pregnant patients undergoing Caesarean section (CS).

Purpose of the Study:

• To evaluate the accuracy and precision of the Masimo Rainbow SET(®) Radical-7 Pulse CO-Oximeter for non-invasive haemoglobin (SpHb) monitoring in patients undergoing elective Caesarean section.
• To compare non-invasive SpHb measurements with traditional laboratory Hb measurements.

Main Methods:

• A prospective, controlled study involving 50 patients undergoing elective CS.
• Non-invasive SpHb values were compared to laboratory Hb values from venous blood samples at baseline, immediately post-CS, and 24 hours post-CS.
• Bland-Altman analysis and mixed-effects regression modelling were used for data analysis.

Main Results:

• The Masimo device exhibited significant positive bias compared to laboratory Hb at baseline (1.22 g dL(-1)) and 24 hours post-CS (1.36 g dL(-1)).
• Bias immediately post-CS was 0.14 g dL(-1).
• Limits of agreement varied, indicating potential variability in accuracy.

Conclusions:

• The variability in bias and limits of agreement of the Masimo Rainbow SET(®) Radical-7 Pulse CO-Oximeter's SpHb may limit its clinical utility in obstetric patients undergoing elective CS.
• Device calibration modifications are necessary to enhance accuracy and precision in this population.