Non-invasive Identification of Preoperative Anaemia (NIPPA)

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

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 Overview

• Status: Completed
• Conditions: Anemia

• Study Type: Observational
• Enrollment (Actual): 166

Contacts and Locations

Study Locations

• United Kingdom
  • The City Of Edinburgh
    • Edinburgh, The City Of Edinburgh, United Kingdom, EH16 4SA
      • Royal Infirmary of Edinburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients scheduled for elective orthopaedic surgery.

Healthy volunteers will be recruited from The Department of Anaesthetics.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy Volunteers
Patients undergoing elective orthopaedic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	January to March 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of the non-invasive device to the gold standard	Intraclass correlation coefficient	January to March 2020
Correlation of the non-invasive device to the gold standard	Interclass correlation coefficient	January to March 2020
Predictive value of the non-invasive device	sensitivity	January to March 2020
Predictive value of the non-invasive device	specificity	January to March 2020
Predictive value of the non-invasive device	positive predictive value	January to March 2020
Predictive value of the non-invasive device	negative predictive value	January to March 2020
Factors independently associated with bias	age in years	January to March 2020
Factors independently associated with bias	sex (male or female)	January to March 2020
Factors independently associated with bias	perfusion index measured by noninvasive device	January to March 2020
Factors independently associated with bias	pleth variability index measured by noninvasive device low signal quality	January to March 2020
Factors independently associated with bias	heart rate measured by noninvasive device low signal quality	January to March 2020
Factors independently associated with bias	SpO2 (peripheral oxygen saturation) measured by noninvasive device low signal quality	January to March 2020
Factors independently associated with bias	low signal quality measured by noninvasive device low signal quality	January to March 2020

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: NHS Lothian

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2020
• Primary Completion (Actual): March 17, 2020
• Study Completion (Actual): March 17, 2020

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: AC19147

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No