Approximately 20% of patients undergoing elective orthopaedic surgery are anaemic. When not identified and treated before surgery, this can lead to requiring blood transfusions, which brings additional expenses, time and inconvenience to the patient.It is recommended that preoperative assessment involves investigation and where possible, treatment of anaemia. The timescale between assessment and surgery makes it difficult to comply with guidelines without postponing surgery. This study will investigate adult patients scheduled for elective orthopaedic surgery, where a full blood count is to be taken as part of routine care. A paired non-invasive reading of their blood will be taken. It will be conducted at The Royal Infirmary, Edinburgh. This device is not in use within the department currently but has been given free of charge for the study. There are no restrictions placed on the device except that it is not accurate for measuring haemoglobin \<8g.dL. Participant care will only be determined by results from the laboratory assay as per routine care, not the noninvasive device. The device is CE marked for haemoglobin determination. Masimo (manufacturer) have released results in the accuracy of their monitor but with very little other information, for example, study population or precision. This study aims to answer how accurate and precise non-invasive measurements are in patients scheduled for orthopaedic surgery (there are no studies with these results) and whether anaemia can be identified earlier in the patient pathway i.e. an anaemia screen at time of surgical listing, therefore leaving ample time for treatment and optimisation of care. The data from the study will not be shared with Masimo. There is ongoing work towards introducing and piloting a new pre-operative triage system where optimisable conditions e.g. anaemia are identified at the time of listing. This study would aid this work.
Study Type
OBSERVATIONAL
Enrollment
166
Royal Infirmary of Edinburgh
Edinburgh, The City of Edinburgh, United Kingdom
The accuracy of the non-invasive device
assessed by calculating the agreement between the results obtained from the gold standard laboratory assay and the non-invasive device
Time frame: January to March 2020
Correlation of the non-invasive device to the gold standard
Intraclass correlation coefficient
Time frame: January to March 2020
Correlation of the non-invasive device to the gold standard
Interclass correlation coefficient
Time frame: January to March 2020
Predictive value of the non-invasive device
sensitivity
Time frame: January to March 2020
Predictive value of the non-invasive device
specificity
Time frame: January to March 2020
Predictive value of the non-invasive device
positive predictive value
Time frame: January to March 2020
Predictive value of the non-invasive device
negative predictive value
Time frame: January to March 2020
Factors independently associated with bias
age in years
Time frame: January to March 2020
Factors independently associated with bias
sex (male or female)
Time frame: January to March 2020
Factors independently associated with bias
perfusion index measured by noninvasive device
Time frame: January to March 2020
Factors independently associated with bias
pleth variability index measured by noninvasive device low signal quality
Time frame: January to March 2020
Factors independently associated with bias
heart rate measured by noninvasive device low signal quality
Time frame: January to March 2020
Factors independently associated with bias
SpO2 (peripheral oxygen saturation) measured by noninvasive device low signal quality
Time frame: January to March 2020
Factors independently associated with bias
low signal quality measured by noninvasive device low signal quality
Time frame: January to March 2020
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