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Completed

NCT Number: NCT04247178

Non-invasive Identification of Preoperative Anaemia

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.

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Key information

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Infirmary of Edinburgh

Edinburgh, The City of Edinburgh, EH16 4SA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. The accuracy of the non-invasive device

    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

Secondary outcomes

  1. Correlation of the non-invasive device to the gold standard

    Time frame: January to March 2020

    Intraclass correlation coefficient

  2. Correlation of the non-invasive device to the gold standard

    Time frame: January to March 2020

    Interclass correlation coefficient

  3. Predictive value of the non-invasive device

    Time frame: January to March 2020

    sensitivity

  4. Predictive value of the non-invasive device

    Time frame: January to March 2020

    specificity

  5. Predictive value of the non-invasive device

    Time frame: January to March 2020

    positive predictive value

  6. Predictive value of the non-invasive device

    Time frame: January to March 2020

    negative predictive value

  7. Factors independently associated with bias

    Time frame: January to March 2020

    age in years

  8. Factors independently associated with bias

    Time frame: January to March 2020

    sex (male or female)

  9. Factors independently associated with bias

    Time frame: January to March 2020

    perfusion index measured by noninvasive device

  10. Factors independently associated with bias

    Time frame: January to March 2020

    pleth variability index measured by noninvasive device low signal quality

  11. Factors independently associated with bias

    Time frame: January to March 2020

    heart rate measured by noninvasive device low signal quality

  12. Factors independently associated with bias

    Time frame: January to March 2020

    SpO2 (peripheral oxygen saturation) measured by noninvasive device low signal quality

  13. Factors independently associated with bias

    Time frame: January to March 2020

    low signal quality measured by noninvasive device low signal quality

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Lothian

Registry information

Official study title

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

Acronym: NIPPA

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 29, 2020
Registry last updated
Nov 5, 2020

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.

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