Royal Infirmary of Edinburgh
Edinburgh, The City of Edinburgh, EH16 4SA, United Kingdom
NCT Number: NCT04247178
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.
Looking for future studies?
Notify Me16 year–80 year
All sexes
Observational
Edinburgh, The City of Edinburgh, EH16 4SA, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
for healthy volunteers cohort:
Exclusion criteria
Exclusion criteria
for healthy volunteers cohort:
Time frame: January to March 2020
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
Intraclass correlation coefficient
Time frame: January to March 2020
Interclass correlation coefficient
Time frame: January to March 2020
sensitivity
Time frame: January to March 2020
specificity
Time frame: January to March 2020
positive predictive value
Time frame: January to March 2020
negative predictive value
Time frame: January to March 2020
age in years
Time frame: January to March 2020
sex (male or female)
Time frame: January to March 2020
perfusion index measured by noninvasive device
Time frame: January to March 2020
pleth variability index measured by noninvasive device low signal quality
Time frame: January to March 2020
heart rate measured by noninvasive device low signal quality
Time frame: January to March 2020
SpO2 (peripheral oxygen saturation) measured by noninvasive device low signal quality
Time frame: January to March 2020
low signal quality measured by noninvasive device low signal quality
University of Edinburgh
Other
NIPPA: Non-Invasive Haemoglobin Measurement to Identify Preoperative Anaemia in Patients Scheduled for Elective Orthopaedic Surgery, a Single-centred Prospective Cohort Study.
Acronym: NIPPA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05750654
Anemia, Hematologic Diseases
Houston, Texas, United States
View Trial DetailsNCT03369210
Anemia, Hematologic Diseases
Aachen, Germany
View Trial DetailsNCT01572506
Anemia, Hematologic Diseases
Baltimore, Maryland, United States
View Trial DetailsNCT07708025
Anemia, Cardiovascular Diseases
Porto, Portugal
View Trial Details