The goal of each prebronchodilator testing set and post-bronchodilator testing set is to achieve a minimum of three acceptable FEV1 and three acceptable FVC measurements. The 2005 ATS/ERS requirement of a minimum FET (1) resulted in some valid maneuvers being classified as inadequate (77, 78, 85).  var params =; It should be noted that FEF25-75 is highly dependent on the validity of the FVC measurement and the degree of expiratory effort. Spirometry should be performed by a healthcare professional who has had appropriate training and who has up‑to‑date skills. The operator must have the ability to override the acceptability designation, because the operator may note a leak, a cough, inadequate inspiration or expiration, or a faulty zero-flow level that was not detected by the software. Newsletter Signup. Thirteen of 19 manufacturers responding to the survey were compliant with ISO 26782:2009. Children may benefit from practicing the different phases of the maneuver before attempting a full maneuver. *Or 10% of the highest value, whichever is greater; applies for age 6 years or younger only. Login The way in which it is measured and used may vary from instrument to instrument (e.g., a simple thermometer or an internal thermistor). Manufacturers must explicitly describe acceptable methods of cleaning and disinfecting their equipment, including recommended chemicals and concentrations, as well as safety precautions for the operator. The repeatability criteria are applied to the differences between the two largest FVC values and the two largest FEV1 values. When signs are present indicating the subject is at full inflation, it is important to give the command to start the forced exhalation immediately to avoid a delay that could result in loss of air prior to application of maximum expiratory effort (back extrapolated volume). A comprehensive guide to aid in the implementation of these standards was developed as an online supplement. The largest FVC and the largest FEV1 observed from all of the acceptable values are reported (or largest usable values if none are acceptable). If the FEV1 from an acceptable test drops below 80% of the start value, the test procedure should be terminated in the interest of patient safety. The inspiratory VC (IVC) is the volume of gas slowly inspired from RV to TLC (Figure 4).  iframe.setAttribute('frameborder', 0); *For children aged 6 years or younger, must have at least 0.75 seconds of expiration without glottic closure or cough for acceptable or usable measurement of FEV0.75. 3. It becomes acceptable if it is within the repeatability tolerance of, or is greater than, a subsequent FVC. The repeatability grade is determined for the set of prebronchodilator maneuvers and the set of post-bronchodilator maneuvers separately. var form = ''; This document is an update of the 2005 American Thoracic Society (ATS) and European Respiratory Society (ERS) standardization of spirometry (1), which in turn built on a wealth of previous work (2–6). iframe.setAttribute('src', form + params); served on an advisory committee for and received research support from Vertex. An application was submitted for a joint ATS and ERS task force to update the 2005 spirometry standards (1). The following illustration shows the four phases of the forced exhalation maneuver. The ability to overlay a series of flow–volume graphs registered at the point of maximal inspiration may be helpful in evaluating repeatability and detecting submaximal efforts.  iframe.setAttribute('height', 850);  iframe.setAttribute('frameborder', 0); You may print one copy of this document at no charge. The American Thoracic Society/European Respiratory Society acceptability criteria for spirometry: asking too much or not enough? Grade “U” was added to denote “usable” values. For children aged 6 years or younger, an acceptable FEV0.75 (the forced expiratory volume in the first 0.75 s) may be obtained from a maneuver with early termination after 0.75 seconds. Reductions in PEF and FEV1 have been shown when inspiration is slow and/or there is a 4- to 6-second pause at TLC before beginning expiration (63, 64). Potential contraindications should be included in the request form for spirometry. If the test is used for diagnosis or to determine whether there is any change in spirometric lung function in response to bronchodilators, then the clinician ordering spirometry will instruct the patient to withhold bronchodilators before baseline testing. Chronic Obstructive Pulmonary disease (COPD) is a clinical diagnosis that should be based on carefully history taking, the presence of symptoms and assessment of airway obstruction (also called airflow limitation). One guideline recommends that treatment might be increased if the per cent forced expiratory volume in 1 s (FEV 1) is <80% or <60% of predicted. The spirometry system must signal the operator when a plateau has been reached or forced expiratory time (FET) reaches 15 seconds. Maneuvers conducted with an erroneous zero-flow level will either under- or overestimate FEV1 and FVC.  iframe.setAttribute('type', 'text/html');  iframe.setAttribute('height', 500);  iframe.setAttribute('height', 850); A patient survey was developed to capture patients’ experiences. However, an acceptable FEV1 measurement may be obtained from a maneuver with early termination after 1 second. FEV1 and FVC measurements from a maneuver with BEV exceeding the limit are neither acceptable nor usable. Tests done while standing are similar to sitting in studies of adults (28), obesity (29), and children (30). Definition of abbreviations: LABA = long-acting β2-agonist; LAMA = long-acting muscarinic antagonist; SABA = short-acting β2-agonist; SAMA = short-acting muscarinic antagonist. It is widely used in the assessment of lung function to provide objective information used in the diagnosis … It is commonly undertaken as part of spirometry testing.  var iframe = document.createElement('iframe'); Although patients should be strongly encouraged to achieve their maximal effort, the operator should be alert to any indication that the patient is experiencing discomfort and should terminate the maneuver if a patient is significantly uncomfortable or is approaching syncope. Some patients with restrictive lung disease and young patients with high elastic recoil can empty their lungs quickly and may not be able to hold an expiratory plateau for 1 second. If the study is performed to diagnose an underlying lung condition, then withholding bronchodilators before testing is useful (see Bronchodilator Responsiveness Testing). • Spirometers are now required to meet International Organization for Standardization (ISO) 26782 standards, but with a maximum permissible accuracy error of ±2.5%. The patient’s age, height, and weight (wearing indoor clothes and without shoes) are recorded. ii GLOBAL INITIATIVE FOR CHRONIC OBSTRUCTIVE LUNG DISEASE POCKET GUIDE TO COPD DIAGNOSIS, MANAGEMENT, AND PREVENTION ... • Spirometry is required to make the diagnosis; the presence of … The operator should record observed signs or symptoms such as cough, wheeze, dyspnea, or cyanosis. Some indica-tions for spirometry are given in table 1. Careers Task force members were scientists and physicians with experience in international guidelines and standards; clinical experience in routine lung function testing; and specialist knowledge of spirometry, including research publications. Definition of abbreviations: FET = forced expiratory time; FEV0.75 = forced expiratory volume in the first 0.75 seconds; FIVC = forced inspiratory VC; PEF = peak expiratory flow. Instructions on withholding medications should be given to the patient at the time of making the appointment. The patient should be seated erect, with shoulders slightly back and chin slightly elevated.  var thisScript = document.scripts[document.scripts.length - 1]; The minimum requirements are as follows: 1) maintenance of a log of calibration results, 2) documentation of repairs or other alterations that return the equipment to acceptable operation, 3) recording of dates of computer software and hardware updates or changes, and 4) recording the dates equipment is changed or relocated (e.g., industrial surveys). G.L.H.

 thisScript.parentElement.replaceChild(iframe, thisScript); var form = ''; Inspection of the flow–volume graph may be added as a measure of the satisfactory start of a test. It is widely used in the assessment of lung function to provide objective information used in the diagnosis of lung diseases and monitoring lung health. Spirometry is an important tool used, in combination with the clinical picture, for diagnosing and assessing conditions such as asthma, COPD, pulmonary fibrosis and cystic fibrosis. Similarly, patients should be informed of the need for reporting ethnicity (58). The ATS standardized report form (114) should be the default report form for spirometry systems. Standardization of Spirometry 2019 Update. Activities That Should Be Avoided before Lung Function Testing. In contrast, a calibration verification is the procedure used to validate that the device is within calibration limits (i.e., ±3% [accuracy tolerance, ±2.5% for spirometers plus ±0.5% for calibration syringes]). VC can be measured using conventional spirometers or equipment used to measure static lung volumes and their subdivisions (124).  var iframe = document.createElement('iframe'); There must be no leak at the mouth (4). FEV1/FEV6 has been shown to be useful in the diagnosis of airflow obstruction in adults (102, 103). In a display of multiple trials, the sequencing of the maneuvers should be apparent to the operator. Temperature is an important variable in most pulmonary function tests and is sometimes measured directly by the instrument. Spirometer temperature should be measured and not assumed to be constant, even over the course of one testing session. By continuing to browse  iframe.setAttribute('type', 'text/html'); With appropriate coaching, children as young as 2.5 years old with normal cognitive and neuromotor function are able to perform acceptable spirometry (8, 59).  var thisScript = document.scripts[document.scripts.length - 1]; x. Brian L. Graham. Definition of abbreviation: N/A = not applicable. The system should also have the capability to export data to electronic medical records, both as .pdf file copies of the printed report and as discrete data, using the Clinical Document Architecture Release 2 standard of HL7 International (115) or Fast Healthcare Interoperability Resources. Patients should avoid the activities listed in Table 5 before testing, and these requirements should be given to the patient at the time of making the appointment. The primary signal measured in spirometry is either volume or flow as a function of time. Lung India 2019;36:S1-35. A study found that an isolated reduction of the FEV3/FVC ratio is an indicator of mild lung injury (141), and reductions in FEV1/FEV6 (142) or FEV3/FEV6 (143) may have higher sensitivity than FEV1/FVC for detecting early airflow limitation.  iframe.setAttribute('src', form + params); The patient should be given an approved hand disinfectant gel or wipe upon first entry into the testing station, because patients will be touching various surfaces, and many spirometers are handheld. COMPLIANCE WITH ATS/ERS 2019. International Organization for Standardization. Volumes in liters and PEF in L/s are reported to two decimal places at BTPS (body temperature, ambient barometric pressure, and saturated with water vapor).  iframe.setAttribute('width', '100%');  iframe.setAttribute('type', 'text/html');  var thisScript = document.scripts[document.scripts.length - 1]; The following criteria were developed as objective measures to determine whether a maximal effort was achieved and acceptable FEV1 and/or FVC measurements were obtained. It is preferable that VC maneuvers be performed before FVC maneuvers because of the potential for muscular fatigue and volume history effects, whereby, after maximal inspiratory efforts, some patients with severe airway obstruction return to a falsely high level of FRC or RV as a result of gas trapping or stress relaxation (4). In contrast, display of the FVC maneuver as a volume–time graph provides more detail for the latter part of the maneuver. If birth sex and/or ethnicity data are not disclosed, the operator notes must alert the interpreter of this omission and state what default values were used for calculating predicted values. The use of disposable, in-line filters for spirometers has become standard practice in most facilities. The patient first performs prebronchodilator spirometry to achieve three acceptable FEV1 and FVC measurements as described previously. Studies have shown that ongoing supervised training using a telemedicine system is effective and valid for assessing and monitoring the quality of the spirometry tests performed in primary health centers in a public health system (131, 132). However, operators are encouraged to know their own usual FEV1 and FVC, which allows them to conduct a quick, rough check if they suspect a problem. For optimal quality control, both volume–time and flow–volume real-time displays are required, and operators must visually inspect the performance of each maneuver for quality assurance before proceeding with another maneuver. Additional standards have been developed for occupational surveillance (7) and for preschool children (8). Patients who see the grade assigned to their values might erroneously assume that the grade applies to the health of their lungs. Table 8 lists suggested withholding times for various bronchodilators.  var thisScript = document.scripts[document.scripts.length - 1]; Errors also occur because of obstruction of a handheld spirometer by improper hand placement. Is it necessary to use a noseclip in the performance of spirometry using a wedge bellows device? Comparison of the FIVC with the FVC will provide feedback to the operator on whether the patient began the forced expiration from full inflation (67). All disposable items, including filters, mouthpieces, noseclips, and gloves, must be disposed of at the end of the testing session. Spirometry should only be undertaken by healthcare professionals who are trained and certified as competent (certificated) in performing and/or interpreting the tests.3,4,5Regular updates and quality audits are fundamental to ensuring the quality of spirometry testing. However, because GLI reference values for FEV0.75 (but not for FEV0.5) are available for ages 3–7 years (59), FEV0.75 should be reported for children aged 6 years or younger, and if FET is >1 second, then FEV1 should also be reported. Before test stop - • short-acting bronchodilators for 4 hours Reducing the effort partway through the maneuver (after 4 s) (65, 66) may give a higher expiratory volume in some patients and may prevent glottic closure and avoid syncope, but then it is no longer a true maximally forced expiration. Must achieve one of these three EOFE indicators: 1.  var iframe = document.createElement('iframe'); For IC, the average value from the acceptable maneuvers should be reported. These standards stress the importance of a maximal inspiration after the forced expiration. Calibration verifications and quality control procedures must be repeated after any such changes before further testing begins. Three or more additional post-bronchodilator acceptable FEV1 and FVC measurements are then obtained after the wait time specified in the facility protocol. Click to see any corrections or updates and to confirm this is the authentic version of record. Impressum • Operator training as well as attainment and maintenance of competency were addressed. Imaging technology has the potential to monitor spirometry without a direct connection to the patient (146), permitting testing of patients unable or unwilling to use a mouthpiece. In addition, the time data are useful for verifying pre- and post-bronchodilator maneuvers. It is easy to remember the adage, “if they don’t breathe it in, they can’t blow it out.” The new standards give detailed guidance on how to vigorously coach patients to full inflation and stress that site operators must actively observe the subject for evidence they are fully inflated. Published date - 23 Apr 2013. Height in centimeters to one decimal place (55) and weight to the nearest 0.5 kg must be recorded; these may also be expressed in inches and pounds on reports in jurisdictions still using those measures. FET is the time in seconds measured from Time 0 to the end of the expiratory plateau or the beginning of inspiration after maximal forced expiration, or the time that the patient comes off the mouthpiece, whichever is shortest. Regulatory …. Formal guidelines for spirometry use were provided  in 2005 through a collaboration between the American Thoracic Society (ATS) and European Respiratory Society (ERS). Methods: This spirometry technical standards document was developed by an international joint task force, appointed by the American Thoracic Society and the European Respiratory Society, with expertise in conducting and analyzing pulmonary function tests, laboratory quality assurance, and developing international standards. } FIVC is the largest inspiratory volume immediately after forced expiration from all of the maneuvers. Meeting repeatability criteria may require performing up to eight maneuvers, with sufficient rest time between the maneuvers so that the operator and patient agree that the next maneuver may begin. 2019 REPORT COPYRIGHTED MATERIAL-DO NOT COPY OR DISTRIBUTE . 1, step 1). Other techniques such as raised volume rapid thoracic compression technique that are used for infants (70) are not included in this document. if (form.indexOf('?') The grading applies to the set of prebronchodilator maneuvers as a whole rather than individual maneuvers and is determined separately for the set of post-bronchodilator maneuvers. Table 3. Multiple prolonged expirations are seldom justified and may cause light-headedness, syncope, undue fatigue, and unnecessary discomfort. Patients with airway obstruction will take longer, but expiration should be terminated after 15 seconds. Continuing research on innovative analyses that may improve diagnoses or lead to earlier diagnosis in at-risk persons is important, and new methods of measuring volume and flow are strongly encouraged. Ulna length should be measured with calipers to avoid error introduced using a tape measure. More advanced analyses of the flow and volume data have been proposed to assist in the automation of spirometry quality assessment (136–138) and to automatically detect errors in early termination, cough, extra breaths, and variable flow (139). if (form.indexOf('?') Displays of flow versus volume provide more detail than volume–time graphs for the first 1 second of the FVC maneuver. Standardization of Spirometry (2005) PDF: • New withholding times for bronchodilators before bronchodilator responsiveness testing were developed. A study of 7,497 calibration verifications of volume spirometers demonstrated the need for more stringent standards (39). This technical report covers definitions, equipment specifications, patient-related procedures, quality control, and data reporting. > 0) { The volume inhaled to full inflation after the end of the forced exhalation is called the forced inspiratory vital capacity (FIVC) and should closely match (within 5% or 0.10L, whichever is larger) the FVC for that effort. Important differences between IVC and EVC maneuvers may be observed in patients with airway obstruction (125–127). ]/g, "&"); August 28, 2007 Contents . thisScript.parentElement.replaceChild(iframe, thisScript); var form = ''; } In many cases, patients can and will achieve closer repeatability than these criteria. *Additional steps may be required by local infection control policies. However, on its own, spirometry does not lead clinicians directly to an aetiological diagnosis. Ethnicity categories for the Global Lung Function Initiative (GLI) reference values (59) are white (i.e., European ancestry), African American, Northeast Asian, Southeast Asian, and other/mixed (Section E7). The grading system that is recommended by the ATS for spirometry reporting (114), which is a modified version of the system developed by Hankinson and colleagues (80) and expanded to include young children, should be used (Table 10). The FET from the maneuver with the largest FVC is reported. Operators should be aware of potential problems with tests performed outside the range of ambient temperatures and barometric pressures specified by the manufacturer for their particular spirometer.  iframe.setAttribute('frameborder', 0); The patient has achieved an FET of 15 seconds. Guidelines from Other Organizations — Current evidence-based guidelines, statements, and consensus reports (by topic) Additional guidelines are available at the National Guideline Clearinghouse. The operator checks that the patient has the proper posture, the noseclip is in place, and the lips are sealed around the mouthpiece. Table 9. Guidelines for the Diagnosis and Management of Asthma . Infection can be transmitted by direct contact with surfaces such as mouthpieces, noseclips, handheld spirometers, chair arms, and immediate proximal surfaces of valves or tubing. Research is needed to validate the EOFE plateau criterion (≤0.025 L in 1 s), which is based on expert opinion dating back to 1979 (2). If the difference in VC between the largest and next largest maneuver is >0.150 L or 10% VC, whichever is smaller, for patients older than 6 years of age or >0.100 L or 10% VC, whichever is smaller, for those aged 6 years or younger, then additional trials should be undertaken. These standards are periodically reviewed, and in November of 2019, the ATS/ERS 2019 Spirometry Update Task Force published an update. In situations when the ambient air temperature is changing rapidly (>3°C in <30 min), continuous temperature corrections may be necessary (Section E5). This will provide a measure of forced inspiratory VC (FIVC).  iframe.setAttribute('width', '100%');  iframe.setAttribute('width', '100%'); †Occurs when the patient cannot expire long enough to achieve a plateau (e.g., children with high elastic recoil or patients with restrictive lung disease) or when the patient inspires or comes off the mouthpiece before a plateau. Large variability in this test is often due to incomplete inspiration. = '0'; Measured Variables (Reported Separately for Pre- and Post-bronchodilator Tests). What does CNS Endpoint Measurement have in Common with the Fosbury Flop? Inspiratory capacity (IC) is the volume change recorded at the mouth when taking a slow full inspiration with no hesitation, inspiring from a position of passive end-tidal expiration (i.e., FRC) to a position of maximum inspiration (i.e., TLC). Although standardization of testing practices has been guided by ATS/ERS for the past few decades, adoption of their recommendations has typically been heterogeneous and slow. ATS and ERS first collaborated to produce a series of joint guidelines for the standardization of lung function testing in 2005 and published an updated technical statement for the standardization of spirometry in October 2019 . B.R.T. A cough during the first second of the maneuver can affect the measured FEV1 value, and the FEV1 from such a maneuver is neither acceptable nor usable. Attention to equipment quality assurance and calibration is an important part of good laboratory practice. The goal of infection control is to prevent the transmission of infection to patients and staff during pulmonary function testing (33, 34). Guidelines. SDK available for iOS and Android. Monitoring lung function by serial spirometry, especially in patients with obstructive lung disease, may be more useful by following post-bronchodilator values (96). Conclusions: Standards and consensus recommendations are presented for manufacturers, clinicians, operators, and researchers with the aims of increasing the accuracy, precision, and quality of spirometric measurements and improving the patient experience.  iframe.setAttribute('width', '100%'); The term “must” is used to indicate a requirement for meeting the standards, and “should” is used to indicate actions that may not be mandatory but are considered to be best practices. The operator should inform the patient that the grade refers to the consistency of their blows. Regardless of the method used, the operator should confirm the accuracy of temperature measurements, and the manufacturer should describe or provide a clear mechanism for checking the accuracy of instrument temperature measurements. This article has an online supplement, which is accessible from this issue’s table of contents at Confirm patient identification, age, birth sex, ethnicity, etc. For FEV1 repeatability, the difference between the largest and the next largest FEV1 is ≤0.150 L for those older than 6 years of age and ≤0.100 L or 10% of the largest FEV1, whichever is greater, for those aged 6 years or younger.  iframe.setAttribute('width', '100%'); A comprehensive review of published evidence was performed.  var iframe = document.createElement('iframe'); • Standardized operator feedback options that promote synoptic reporting were developed. For patients with airway obstruction or older patients, longer FETs are frequently achieved; however, FETs >15 seconds will rarely change clinical decisions (1, 4).  iframe.setAttribute('frameborder', 0); Key learning points. If variable flow is detected during the zero-flow setting procedure or if the zero level has changed significantly, the zero-flow setting procedure must be repeated. Otherwise, the operator will ask the patient to provide this information. Calibration verifications must be undertaken daily, or more frequently if specified by the manufacturer. While community transmission of the virus is occurring in your region, postpone spirometry and peak flow measurement within health care facilities unless there is an urgent need. Patients should be as relaxed as possible before and during the tests. Sample warning messages and suggested corrections are provided in Section E8. This could be addressed by having an analog or digital display of flow in ml/s on the screen to give patients feedback on their expiratory rate during the maneuver.