Clinical trial NCT04247178: Non-invasive Identification of Preoperative Anaemia
Official title: NIPPA: Non-Invasive Haemoglobin Measurement to Identify Preoperative Anaemia in Patients Scheduled for Elective Orthopaedic Surgery, a Single-centred Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2020-01-29
Enrollment: 166
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for elective orthopaedic surgery.

Healthy volunteers will be recruited from The Department of Anaesthetics.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* able to provide informed consent
* aged between 16-80 years old
* scheduled for elective orthopaedic surgery
* a full blood count (FBC) is to be taken as part of routine care

Inclusion Criteria for healthy volunteers cohort:

* able to provide informed consent
* aged between 16-80 years old

Exclusion Criteria:

* Patients with haemoglobin disorders
* Raynaud's disease (or any other condition affecting the blood supply to the digits).

Exclusion Criteria for healthy volunteers cohort:

* Patients with haemoglobin disorders
* Raynaud's disease (or any other condition affecting the blood supply to the digits).

Primary outcomes:
measure: The accuracy of the non-invasive device
timeFrame: January to March 2020
Secondary outcomes:
measure: Correlation of the non-invasive device to the gold standard
timeFrame: January to March 2020
measure: Correlation of the non-invasive device to the gold standard
timeFrame: January to March 2020
measure: Predictive value of the non-invasive device
timeFrame: January to March 2020
measure: Predictive value of the non-invasive device
timeFrame: January to March 2020
measure: Predictive value of the non-invasive device
timeFrame: January to March 2020
measure: Predictive value of the non-invasive device
timeFrame: January to March 2020
measure: Factors independently associated with bias
timeFrame: January to March 2020
measure: Factors independently associated with bias
timeFrame: January to March 2020
measure: Factors independently associated with bias
timeFrame: January to March 2020
measure: Factors independently associated with bias
timeFrame: January to March 2020
measure: Factors independently associated with bias
timeFrame: January to March 2020
measure: Factors independently associated with bias
timeFrame: January to March 2020
measure: Factors independently associated with bias
timeFrame: January to March 2020
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: The City Of Edinburgh
Study officials:
References: