Masimo said that it has found significant positive correlations with its Masimo SpHb device between non-invasive haemoglobin (SpHb) and invasive haemoglobin (Hb) values in a study on patients undergoing elective caesarean section (CS) with antepartum haemorrhage.
Published in the Egyptian Journal of Anesthesia, the study assessed the accuracy of non-invasive, continuous haemoglobin monitoring with Masimo SpHb during elective cesarean section.
The team of researchers, involved in the study, stated: “In patients undergoing CS with antepartum haemorrhage, continuous SpHb through Masimo Pulse CO-Oximetry demonstrated clinically acceptable accuracy of Hb measurement compared with invasive Hb, even at low haemoglobin levels.”
During the trial, the researchers recruited 60 pregnant women, aged 18-45, who were to undergo elective CS under general anaesthesia between April 2016 and December 2017.
As per the US-based firm, the significant positive correlations between SpHb and invasive Hb were recorded at baseline, pre-transfusion, and post-transfusion points of comparison.
By using Bland-Altman analysis, the researchers noted low bias and moderate limits of agreement of 0.348 grams per decilitre (g/dL) at baseline measurement, 0.314g/dL at pre-transfusion, and 0.348g/dL at post-transfusion.
The investigators said: “Continuous SpHb Masimo Pulse CO-Oximetry shows an appropriate clinically reliable Hb calculation in comparison to Invasive Hb even in patients undergoing CS with low haemoglobin.
“Further studies are needed on larger sample size with multicenter collaboration. Furthermore, we recommend the assessment of this technique on patients with common morbidities, such as high cholesterol, high blood pressure, and diabetes.
“SpHb evaluation has the potential for additional benefits, including patient comfort, increased safety, and decreased complexity for healthcare staff, who are not exposed to the risks of needle-stick injury and bloodspill contamination.”
In the trial, all 60 subjects had an antepartum haemorrhage and were candidates for blood transfusion. They were monitored according to hospital standards, as well as with Masimo SpHb.
The medical device company said that lab Hb and SpHb values were recorded prior to inducing anaesthesia, before transfusion, and post-transfusion.
