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Non-invasive Identification of Preoperative Anaemia

NIPPA: Non-Invasive Haemoglobin Measurement to Identify Preoperative Anaemia in Patients Scheduled for Elective Orthopaedic Surgery, a Single-centred Prospective Cohort Study.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04247178
Acronym
NIPPA
Enrollment
166
Registered
2020-01-29
Start date
2020-01-31
Completion date
2020-03-17
Last updated
2020-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

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.

Interventions

None listed

Sponsors

NHS Lothian
CollaboratorOTHER_GOV
University of Edinburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
The accuracy of the non-invasive deviceJanuary to March 2020assessed by calculating the agreement between the results obtained from the gold standard laboratory assay and the non-invasive device

Secondary

MeasureTime frameDescription
Predictive value of the non-invasive deviceJanuary to March 2020sensitivity
Factors independently associated with biasJanuary to March 2020age in years
Correlation of the non-invasive device to the gold standardJanuary to March 2020Intraclass correlation coefficient

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026