Guidelines for setting up a

spirometry
service
Flow
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Helping people to breathe easier

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Volume
Normal Spirometry
 Introduction

Spirometry is the most basic objective measurement of lung function. The results
of well-performed spirometry give an indication of whether airflow and lung volume
are appropriate for a patient’s age, sex and height i.e. whether there is significant
airflow obstruction (e.g. asthma or emphysema) or a significant reduction in lung
volume (e.g. suggestive of a restrictive lung disease). Good quality spirometry
requires a trained and experienced operator.

If spirometry results are to be clinically useful then they are criticially dependent
on an accurately calibrated instrument capable of making the measurements
precisely, an operator trained to recognise correct measurement techniques and
a consistent and maximal effort by the patient.

There are many publications outlining good spirometry practice including

Standards established by the American Thoracic Society (ATS Am J Respir Crit
Care Med Vol 152, 1995), upon which New Zealand practice is based.

These guidelines were prepared by Maureen Swanney,

Scientific Director, Respiratory Physiology Laboratory
Christchurch Hospital.
 Standardisation of Spirometry

There are four critical phases to performing quality spirometry

1. A full inspiration preceding the expiratory manoeuvre

2. A rapid forced expiration from a full lung
3. A complete exhalation until the lungs are completely empty
4. The manoeuvre is free from artefact i.e. cough, glottic
closure etc.

Useful results depend on the elimination of variables other than those you are
interested in i.e. variable inflation (alters expiratory force) and variable effort.
Successful control of these other variables is gauged by reproducibility of the
results. Accordingly, a minimum of three manoeuvres must be completed and
the two best FEV1s and FVCs must be at least within 200ml of each other. The
first manoeuvre is often poor due to the learning required to do the test
successfully so four manoeuvres are commonly required. It is recommended
that no more than eight manoeuvres are performed at one session.

Lung volume and air flow depend on chest size. Therefore, reference values are
determined from the patient’s age, sex and height. It is essential that the reference
values used are appropriate to the patient being tested. Your nearest respiratory
laboratory can advise you on the choice of prediction equations. Although many
spirometers already contain this information the ‘pre-set’ reference values may
be inappropriate for our population in New Zealand.
 Calibration and Quality Assurance
Calibration
Depending on the flow measuring technology, some spirometers require
calibration each session. This requires a calibrated syringe (ideally 3 litre) with a
leak free connection to the spirometer. The spirometer should be calibrated at
two or three flows (high, mid and low flow) and the proceedure should include
inspiratory and expiratory flows.

A number of spirometers do not allow calibration. This is a consequence of design.

Inability to calibrate, however, does NOT absolve the operator from the need to
validate the instrument.

Validation
ALL spirometers require regular validation. There are two aspects to this process.

1. Validation simply requires using your calibration syringe to make a vital

capacity (VC) manoeuvre and verifying the result is accurate. Again this
should be done at multiple flows to ensure linearity of response. Your local
respiratory laboratory may be able to offer this service. The expected
accuracy of volume calibration should be within 3% of the reference volume
or 50 mls (whichever is greater). For example at 3 litres the volume of the
spirometer should read within 2.91 – 3.09 L (at room temperature).

2. Biological Controls are an equally important component of validation.

Spirometry should be regularly performed on a person (or better a group of
people) who is a non-smoker, has no history of respiratory disease and
stable lung function. These subjects should have their best values recorded
along with the variability in their results. Tests should be performed at
regular intervals, say once a week and a record of FEV1 and FVC should be
kept. Comparison of the measured values against their usual range allows
immediate verification that the spirometer is measuring correctly. The
advantage of biological control, over syringe control, is that the biological
control tests assess all aspects of the instrument’s function including
operator technique.

Your local respiratory laboratory will be able to assist you to set up this biological
control programme should help be needed. However, using yourself and staff as
controls is the approach most usually employed.
Environmental Conditions
Gas volumes depend on pressure and temperature. Variation in pressure is not
great and is rarely an issue. Air expands when heated, thus 2 litres of air in a
room at 21°C will become 2.2 litres when inhaled into the lung at 37°C. Unless
the spirometer has an internal temperature sensor, the operator must have access
to accurate temperature recordings in the room in which spirometry is performed
so the appropriate temperature correction of volume can be made. It is important
that the measuring head of the spirometer is at room temperature before testing
is commenced. A cold instrument from the car boot used in a warm room before
the temperature of the instrument has equilibrated will generate erroneous results.
Similarly a flow-head lying in the sun on a desk will be at a different temperature
from the room and will also generate erroneous results.
Preventers
Infection Control
Guidelines recommend that the staff member and the patient should wash their
hands prior to testing.

It has become common practice to use bacterial/viral barrier filters on the flow-
head of the spirometer. These filters lower the risk of cross infection between
patients. These filters must be chosen carefully to ensure they do not compromise
the measurements through imposing a resistance to airflow. ATS guidelines
provide specifications for air flow resistance in a spirometer, the addition of a
filter must not exceed this tolerance. An additional benefit of filter use is that the
patient perceives their use to be an assurance that they are being protected from
infection.

One brand of spirometer uses a disposable mouthpiece that isolates the exhaled
breath from the spirometer. In this case there is no need for a barrier filter.

The disposable mouthpieces retail at approximately $3.50 each. Filters range in

price from $3.50 to $5.00 each.

If filters are not used it is usual practice to wash/disinfect the flow-head of the
spirometer between patients. You will need several flow-heads if you wish to
test more than one patient within the time it takes for the flow-head to dry
completely and be recalibrated.
There are other mouthpieces that contain a one-way valve preventing inspiration
through the mouthpiece. These may be adequate but they prevent the
measurement of inspiratory flow. Another consideration is that while the
instruction is to exhale into the spirometer some people have difficulty
comprehending the required manoeuvre and will attempt to inspire. Anecdotally,
there have been incidents of inhaling the valve. They may be cheap but are not
an ideal solution. In addition, these mouthpieces do not prevent exposure of the
flow-head to moisture.

The outside of the spirometer should be wiped down between patients. Depending
on the frequency of use it is recommended that the flow-head be cleaned
periodically. It is ESSENTIAL that after any cleaning the spirometer’s calibration
is verified following reassembly.

Training personnel
Quality spirometry requires comprehensive training. The Australian and New
Zealand Society of Respiratory Science in association with the Thoracic Society
of Australia and New Zealand have developed a guideline for spirometry training
courses preparatory to registering training courses available in Australia and
New Zealand. Formal spirometry training courses are available in Auckland and
Christchurch. Other centres in New Zealand will provide training, as the demand
requires.

It is well documented that skill updating is a critical part of any quality assurance
programme.

There is potential to do harm when performing spirometry and staff must

understand the risks and how to deal with emergencies should they arise.

Core content of suitable training courses includes comprehensive

training in:
• Knowledge of internationally accepted guidelines.
• Practical knowledge of how to perform quality spirometry.
• Principles of measurement and the importance of quality control.
• Infection control.
• Knowledge of indications for testing.
• Knowledge of contraindications to testing.
• Basic interpretation skills, whether for diagnosis, research or disability
assessment.
Interpretation algorithm
Obstructive or Restrictive?

1. Examine reported data for accuracy and reproducibility and refer to additional
technical comments on test performance.
2. Determine if the FEV1/FVC ratio is normal or reduced (below the reference
range).
3. If the ratio is normal or high, examine the vital capacity, if FVC is low the
result suggests a restrictive pattern and referral for lung volume testing is
recommended. Otherwise you can be confident the result is within the
reference range.
4. If the FEV1 is low (below the reference range), obstructive lung disease is
present. The severity of obstruction is assessed using the % predicted
FEV1.

Figure 2. Restrictive pattern. FEV1/FVC ratio elevated. Reduced FVC at 66 per cent
reference value i.e. below the 95% C. I.
Age: 49 Height (cm): 167 Weight (kg): 146.5 BMI: 52.53 Gender: male
Ref Pre Pre Post Post CI LLN
Meas %Ref Meas % Chg
FEV1 (L) 3.24 2.27 70 1.00
FVC (L) 4.30 **2.85 **66 1.36
FEV1/FVC % 75 80
PEF (L/sec) 8.05 7.59 94 3.87
FEF25-75 (L/sec) 4.09 2.72 67 2.67
FET100% (sec) 14.86
FEV6 4.23 2.69 64 3.43
FEV1/FEV6 80 84 72

Figure 3. Obstructive pattern with clinically significant bronchodilator response. FEV1

percentage reference shows an improvement from 64 to 92 per cent
Age: 59 Height (cm): 172 Weight (kg): 92.0 BMI: 31.10 Gender: male
Ref Pre Pre Post Post CI LLN
Meas %Ref Meas % Chg
FEV1 (L) 3.11 **2.00 **64 2.85 42 1.00
FVC (L) 4.35 3.40 78 4.10 21 1.36
FEV1/FVC % 72 59 69
PEF (L/sec) 8.17 4.45 54 6.81 53 3.87
FEF25-75 (L/sec) 4.06 **1.23 **30 2.24 82 2.67
FET100% (sec) 7.46 10.62 42
FEV6 4.22 3.40 81 3.97 17 3.34
FEV1/FEV6 79 59 72 70
 Severity of Obstruction?

The severity can be categorised using the TSANZ criteria

Mild Obstruction % Pred FEV1 > 60%
Moderate Obstruction % Pred FEV1 < 60 and > 40%
Severe Obstruction % Pred FEV1 < 40%

Figure 4. Severe obstructive pattern with no bronchodilator response. FEV1/FVC ratio 22

per cent. FEV1 36 per cent of reference value. Note expiratory time of 20 seconds
Age: 78 Height (cm): 175 Weight (kg): 77 BMI: 25.14
Gender: male
Ref Pre Pre Post Post CI LLN
Meas %Ref Meas % Chg
FEV1 (L) 2.59 **0.93 **36 **0.94 1 1.00
FVC (L) 4.02 4.20 104 4.06 -3 1.36
FEV1/FVC % 67 22 23
PEF (L/sec) 7.75 **2.58 *33 **2.23 -13 3.87
FEF25-75 (L/sec) 3.57 **0.28 **8 **0.29 4 2.67
FET100% (sec) 20.64 20.56 -0
FEV6 3.67 2.51 68 2.62 4 2.79
FEV1/FEV6 77 37 36 68

Green = REF; blue = PRE; red = POST

Reversibility testing
1. Confirm the patient has withheld medication appropriately prior to testing
reversibility eg. salbutamol for 6 hours, salmeterol for 24 hours.
2. Measure baseline spirometry in usual way
3. Administer bronchodilator medication (MDI and spacer or nebuliser).
4. Wait the required time for peak efficacy.
• 15-20 minutes for salbutamol.
• 25-30 minutes for ipratropium bromide or salbutamol with ipratropium
bromide.
5. Perform post-bronchodilator spirometry as for baseline test.

Significant reversibility is defined (TSANZ) as greater than 12% improvement in

FEV1 and/or an increase of 200 ml (200 ml is the natural variability of the test).
Note that FVC can also rise significantly such that FEV1/FVC can fall despite
good bronchodilation. Do not use FEF25-75% for assessing reversibility.

Reversibility may also be assessed measuring spirometry before and after a

one-month trial of inhaled glucocorticosteroids or 2 weeks of oral prednisone
with spirometry on the last day of the trial.
• Knowledge of bronchodilators and reversibility testing.
• Choosing appropriate reference equations.
• Trouble-shooting skills.
• Choosing appropriate and reliable equipment.

Competency training will probably become mandatory and it will become

important to demonstrate competency on an ongoing basis. There is a
professional responsibility to be competent and this will increasingly be an issue
for accreditation of services, insurance and ACC claims and the responsibility to
detect early disease.

Interpretation of spirometry
Spirometers are able to produce a long list of indices in their reports. The
frequency of introducing a false negative result increases with the number of
indices reported. A simple regimen for interpreting data is to limit your inquiry
to three parameters viz. FEV1/FVC, FEV1 and FVC, plus careful inspection of the
accompanying flow-volume or volume-time curves. The following is a simple
guide to interpreting spirometry.

Figure 1. Normal spirometry (see cover diagram)

Age: 46 Height (cm): 166 Weight (kg): 57.0 BMI: 20.69 Gender: female

Ref Pre Pre Post Post CI LLN

Meas %Ref Meas % Chg
FEV1 (L) 2.70 2.94 109 0.84
FVC (L) 3.52 3.63 103 0.99
FEV1/FVC % 76 81
PEF (L/sec) 6.20 8.30 134 2.84
FEF25-75 (L/sec) 3.79 4.47 118 1.82
FET100% (sec) 15.96
FEV6 3.69 3.74 94 2.98
FEV1/FEV6 83 85 74
 Choosing a spirometer
While cost is always an important consideration when choosing equipment, the
ability of the instrument to deliver quality results should be more important.
Key features of a spirometer suitable for diagnostic testing
• It must have a comprehensive manual, which describes features, usage
and maintenance.
• It must have a real-time display of the flow-volume graphic visible during
testing to allow monitoring and coaching for the manoeuvre. The real-time
display must be of adequate size to allow comment on the acceptability of
the test.
• It must be able to record for a sufficient time to enable the complete
manoeuvre to be recorded. It could take more than 15 secs for a COPD
patient to exhale completely.
• It must allow the operator to verify and choose the best test data.
• It must allow the operator to select the appropriate reference values.
• The printed report should be of suitable size and contain the information
required including last calibration/verification date, source of predicted
values, patient demographics, date of test and the desired measurements.
It should be possible to include a flow-volume graphic in the report.
• Must have software feedback on the quality of each test.
• Spirometry indices must be corrected to and reported at BTPS conditions.
• It must be easy to calibrate (if appropriate) and validate the instrument.

In addition the supplier of the instrument must provide

• Training in the use of the equipment after purchasing (this training does not
replace a spirometry training course).
• Reliable access to servicing from the manufacturer through their
representatives.

The spirometers listed overleaf satisfy most of these criteria. The list does not
cover all available instruments either because they are not recommended or
they are new to the market and we are unaware of them. The majority of
spirometers at the lower end of the market are intended for monitoring purposes
only and are not designed for diagnostic purposes. Monitoring spirometers are
useful for single patient use but have limitations for diagnostic use.

All the spirometers listed can be linked into a PC for data storage. The prices
quoted are for a single instrument. Bulk purchases will attract a discount.
 Spirometer Manufacturer Price Distributor
SpiroPro SensorMedics/ $4,000.00 CARE Medical
(Printer not included) Jaegar + GST 0800 333 444
[email protected]
Flowscreen Jaegar $5,800.00
(Integrated ticket + GST
thermal printer)

Easy One ndd $3,850.00 McLaren Medical Ltd

(may be downloaded + GST 0800 626 334
to any printer) [email protected]
Optional software $750.00
+ GST

Spirolab II MIR $4,200.00 McLaren Medical Ltd

(Built in printer, Winspiro + GST 0800 626 334
software CD included) [email protected]

Microloop Micro Medical $3,760.00 Cass Distributors

(SPIDA windows + GST 0800 122 277
software included [email protected]
Printer not included)

Microlab Micro Medical $4,385.00

(Built in printer, SPIDA + GST
software not included)

Microlab Micro Medical $5,370.00

(Built in printer, SPIDA + GST
software included)

Readings
Pocket Guide to Spirometry. David P Johns and Rob Pierce. McGraw-Hill Australia Pty Ltd.
ISBN 0 074 71331 0.

Medical Section of the American Lung Association. 1994. Standardization of spirometry: 1994
update. Am. J. Respir. Crit. Care Med. 152:1107-1136.

G.T. Ferguson, P.L. Enright, A.S. Buist, and M.W. Higgins. 2000. Office spirometry for lung
health assessment in adults: A consensus statement from the national lung health education
program. Chest 117:1146-1161.

Medical Section of the American Lung Association. 1991. Lung function testing: selection of
reference values and interpretative strategies. Am. Rev. Respir. Dis. 144:1202-1218.
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