AnemiaNIPPANCT04247178
Non-invasive Identification of Preoperative Anaemia
An observational study of Anemia, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- How many people
- 166 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jan 2020to 17 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients scheduled for elective orthopaedic surgery. Healthy volunteers will be recruited from The Department of Anaesthetics.
Who may be able to join
- 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
- able to provide informed consent
- aged between 16-80 years old
Who cannot join
- Patients with haemoglobin disorders
- Raynaud's disease (or any other condition affecting the blood supply to the digits).
- Patients with haemoglobin disorders
- Raynaud's disease (or any other condition affecting the blood supply to the digits).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, The City of Edinburgh, EH16 4SA
About this study
Official title: 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.
Read more
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.
- Conditions
- Anemia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing elective orthopaedic surgery | Not described | |
| Healthy Volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: January to March 2020
Secondary outcomes (13)
Correlation of the non-invasive device to the gold standard
Intraclass correlation coefficient
Measured: January to March 2020
Correlation of the non-invasive device to the gold standard
Interclass correlation coefficient
Measured: January to March 2020
Predictive value of the non-invasive device
sensitivity
Measured: January to March 2020
Predictive value of the non-invasive device
specificity
Measured: January to March 2020
Predictive value of the non-invasive device
positive predictive value
Measured: January to March 2020
Predictive value of the non-invasive device
negative predictive value
Measured: January to March 2020
Factors independently associated with bias
age in years
Measured: January to March 2020
Factors independently associated with bias
sex (male or female)
Measured: January to March 2020
Factors independently associated with bias
perfusion index measured by noninvasive device
Measured: January to March 2020
Factors independently associated with bias
pleth variability index measured by noninvasive device low signal quality
Measured: January to March 2020
Factors independently associated with bias
heart rate measured by noninvasive device low signal quality
Measured: January to March 2020
Factors independently associated with bias
SpO2 (peripheral oxygen saturation) measured by noninvasive device low signal quality
Measured: January to March 2020
Factors independently associated with bias
low signal quality measured by noninvasive device low signal quality
Measured: January to March 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start31 Jan 2020
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247178
- Sponsor's protocol ID
- AC19147
- Acronym
- NIPPA
- Status last verified
- Nov 2020
- First submitted
- 22 Jan 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIPPA: Non-Invasive Haemoglobin Measurement to Identify Preoperative Anaemia in Patients Scheduled for Elective Orthopaedic Surgery, a Single-centred Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT04247178
- Acronym / sponsor ID
- NIPPA / AC19147
- Conditions
- Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 29 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing elective orthopaedic surgery | – | – |
| Healthy Volunteers | – | – |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients scheduled for elective orthopaedic surgery. Healthy volunteers will be recruited from The Department of Anaesthetics.
Key inclusion criteria (6 listed)
- 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
- able to provide informed consent
Key exclusion criteria (4 listed)
- Patients with haemoglobin disorders
- Raynaud's disease (or any other condition affecting the blood supply to the digits).
- Patients with haemoglobin disorders
- Raynaud's disease (or any other condition affecting the blood supply to the digits).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
13 secondary outcomes
Correlation of the non-invasive device to the gold standard
Time frame: January to March 2020
Correlation of the non-invasive device to the gold standard
Time frame: January to March 2020
Predictive value of the non-invasive device
Time frame: January to March 2020
Predictive value of the non-invasive device
Time frame: January to March 2020
Predictive value of the non-invasive device
Time frame: January to March 2020
Predictive value of the non-invasive device
Time frame: January to March 2020
Factors independently associated with bias
Time frame: January to March 2020
Factors independently associated with bias
Time frame: January to March 2020
Factors independently associated with bias
Time frame: January to March 2020
Factors independently associated with bias
Time frame: January to March 2020
Factors independently associated with bias
Time frame: January to March 2020
Factors independently associated with bias
Time frame: January to March 2020
Factors independently associated with bias
Time frame: January to March 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of the non-invasive device (time frame: January to March 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.