For the maneuvers described below, a noseclip or manual occlusion of the nostrils should be used. 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. Otherwise, the operator will ask the patient to provide this information. Training courses for conducting quality spirometry testing are available in many countries, which has led to operators following ATS/ERS standards (14, 15, 49–51), but short-term follow-up and supplementary training are important to maintain quality (52, 53). 2019 REPORT COPYRIGHTED MATERIAL-DO NOT COPY OR DISTRIBUTE . The 2005 ATS/ERS requirement of a minimum FET (1) resulted in some valid maneuvers being classified as inadequate (77, 78, 85). Guidelines for the Diagnosis and Management of Asthma . These standards stress the importance of a maximal inspiration after the forced expiration. The patient should be seated erect, with shoulders slightly back and chin slightly elevated. Once the zero-flow level has been determined, the patient should insert the mouthpiece and be instructed to breathe normally or easily. The recommendations in this document represent a consensus of task force members in regard to the evidence available for various aspects of spirometric measurement (as cited in the document) and otherwise reflects the expert opinion of the task force members for areas in which peer-reviewed evidence was either not available or incomplete. The expiratory VC (EVC) is the volume of gas slowly expired from TLC to RV. For patients with airway obstruction or older patients, longer FETs are frequently achieved; however, FETs >15 seconds will rarely change clinical decisions (1, 4). Quality ID #51 (NQF 0091): Chronic Obstructive Pulmonary Disease (COPD): … denominator criteria are used to identify the intended patient population. For a slow VC, a maximum of eight maneuvers is a practical upper limit. Although FEV1, FVC, and FEV1/FVC are obligatory, the facility manager must have the ability to configure the report to include the other optional variables, such as FEV6, FEV1/FEV6, FEV0.5, and mean forced expiratory flow, midexpiratory phase (forced expiratory flow between 25% and 75% of the FVC). Real time plethysmographic curve. 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). The ambient temperature must always be recorded with an accuracy of ±1°C. 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. Spirometry is recommended in both asthma and chronic obstructive pulmonary disease (COPD) guidelines; Variability in the performance and understanding of spirometry interpretation has resulted in an estimated 50% of people having an incorrect diagnosis 1; Spirometry consists of two measurements, the relaxed vital capacity (VC) and the forced vital capacity (FVC) The operator must have the ability to override the BEV acceptability designation for such patients. Standardization of Spirometry 2019 Update. Scope This guideline provides information for all health practitioners who perform adult spirometry as part of their clinical duties. On arrival, all of these points must be checked, and any deviations from them must be recorded. Possible precautions include reserving equipment for the sole purpose of testing infected patients or testing such patients at the end of the workday to allow time for spirometer disassembly and disinfection and/or testing patients in their own rooms with adequate ventilation and appropriate protection for the operator. Patients unable to use a mouthpiece may be able to use a face mask (62). The ATS/ERS statement on pulmonary function testing in preschool children states that FEV0.75 and FEV0.5 should be reported (8).  iframe.style.border = '0'; > 0) { A patient who looks comfortable is not likely to be at full inflation. All manufacturers of spirometry equipment were sent a survey requesting equipment specifications. Because normal baseline spirometry does not rule out a bronchodilator response, all initial spirometry done for diagnostic reasons should be performed before and after bronchodilator administration.  iframe.style.border = '0'; One of the most important changes to the guidelines came from evidence that forced exhalation could be performed perfectly but still gives erroneously low results because the forced exhalation started from a lung volume below full inflation. Encouragement, detailed but simple instructions, lack of intimidation, and visual feedback in the teaching are important in helping children to perform the maneuver (8, 68). } Previously, the term “reversibility testing” has been used, but the term “bronchodilator responsiveness testing” is used in these standards to avoid the unwarranted inference that “reversibility” implies the complete elimination of airway obstruction (92). Therefore, laboratories using such equipment are expected to exceed accuracy requirements for spirometry. served as a speaker for Medical Graphics Corporation and Genentech; and served on an advisory committee for Genentech.  iframe.setAttribute('allowTransparency', 'true'); thisScript.parentElement.replaceChild(iframe, thisScript);  The calculation of Time 0 may be improved by breakpoint methods using a recursive, segmented linear regression technique (135). If these criteria are not met in three maneuvers, additional trials must be attempted, up to eight maneuvers in adults, although more may be done in children (Figure 3). 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. Testing should preferably occur in a quiet and comfortable environment that is separated from the waiting room and other patients being tested.  iframe.setAttribute('allowTransparency', 'true'); Definition of abbreviation: N/A = not applicable. If you would like to renew your certification you will be required to resubmit some parts of the online porftfolio, including calibration, quality assurance and produce 10 spirometry tests that you have personally performed. Standardization of Spirometry 2019 Update. Other techniques such as raised volume rapid thoracic compression technique that are used for infants (70) are not included in this document. Inhaled corticosteroids and leukotriene modifiers need not be withheld. Constraints on the development of these standards are listed in Section E12.  iframe.style.border = '0'; If spirometry is needed urgently for clinical management, Some indica-tions for spirometry are given in table 1. Spirometry is fundamental in the assessment of general respiratory health. This official technical statement was approved by the American Thoracic Society and the European Respiratory Society September 2019. It is widely used in the assessment of lung function to provide objective information used in the diagnosis … 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. A 20-year review of 186,000 pulmonary function tests in a tertiary institution found that patient safety incidents occurred in 5 of every 10,000 routine pulmonary function tests (excluding exercise and provocation tests) with generally low risk of harm (21). Capture High Quality Respiratory Data: Don’t Let Spirometers Get in the Way, 3 Strategies to Capture ~ 100% Acceptable Respiratory Data in Clinical Trials. The interpreter must be aware that an apparent change in FVC after bronchodilator administration may be due to a change in FET. In many cases, patients can and will achieve closer repeatability than these criteria. International Organization for Standardization. Some patients may not be able to meet the criteria for acceptability and repeatability that are necessary for grade A, but nevertheless, their results may be clinically useful. Recognizing a satisfactory EOFE is important to ensure that a true FVC has been achieved. How often does spirometry testing induce cardiac arrhythmias? Updated standards are required for unattended home monitoring spirometry (128–130) and peak flow monitoring. For studies to determine a response to an existing therapeutic regimen, bronchodilator medications are generally not withheld. The IC may be underestimated if the inspiratory maneuver is too slow because of poor effort or hesitation or if there is premature closure of the glottis. iframe.setAttribute('src', form + params); In this document, the “operator” is the person conducting the test; the term “patient” is used for the person being tested, recognizing that not all persons will be patients; and “maneuver” is the term used for the inspiratory and expiratory VC excursions. This quivering is caused by isometric contraction of accessory muscles of inspiration which cannot increase the volume of the thorax further. Activities That Should Be Avoided before Lung Function Testing. Similarly, patients should be informed of the need for reporting ethnicity (58). The following measurements are reported separately for the sets of prebronchodilator and post-bronchodilator maneuvers (Table 9).  var params = window.location.search; For within-maneuver acceptability, the FVC must be greater than, or within the repeatability tolerance (see below) of, the largest FVC observed before this maneuver in the current testing set. Note: Withholding times for post-bronchodilator testing are shorter than those for methacholine challenge testing (147) because the bronchoprotection provided by these agents lasts longer than their bronchodilation effects. The decision to withhold long- and short-acting bronchodilators before testing is a clinical one determined by the referring healthcare professional. Manufacturers must ensure that all spirometers meet the standards contained in the current update of ISO 26782 (38). 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. Flowchart outlining the end of forced expiration (EOFE) acceptability criteria for FVC. A study has questioned whether the previously recommended ATS standard waveforms were sufficient (40). The forced expiratory maneuver used in spirometry increases intrathoracic, intraabdominal, and intracranial pressures (16–20). Kevin McCarthy, RPFT is a former manager of Pulmonary Function at the Cleveland Clinic Health System, ERT Clinical Overread Specialist and member of the ATS Proficiency Standards for Pulmonary Function Laboratories committee and the ATS/ERS 2019 Spirometry Update Task Force. For example, the spirometry maneuver may trigger the cough reflex, and after the first one or two attempts, the patient may not be able to do another acceptable maneuver. Post-Approval ]/g, "&"); Summary of Acceptability, Usability, and Repeatability Criteria for FEV1 and FVC.  var form = 'https://content.ert.com/l/71652/2019-08-22/6w37fj?Hidden_Product_Line=VirtualVisits'; During the inspiration, the operator should coach the patient using phrases such as “more, more, more.” Indicators of maximal inspiration include eyebrows raising or eyes widening, and sometimes the head begins to quiver. A child-friendly environment is important for successful testing. When the first post-bronchodilator maneuver is initiated by the operator, the system must display the time elapsed since the last prebronchodilator maneuver. }  iframe.style.border = '0'; This technical report covers definitions, equipment specifications, patient-related procedures, quality control, and data reporting. Calibration verifications must be undertaken daily, or more frequently if specified by the manufacturer.  iframe.setAttribute('height', 850); Key learning points. Spirometry should be performed by a healthcare professional who has had appropriate training and who has up‑to‑date skills. A chair with arms (to prevent falling sideways should syncope occur), without wheels, and with a height adjustment so that the feet are flat on the floor should be used. For between-maneuver evaluation, as with forced maneuvers, a minimum of three acceptable VC maneuvers must be obtained. Hence, for the prebronchodilator and post-bronchodilator testing sets analyzed separately, all FVC values from maneuvers without a plateau and FET <15 seconds that are within the repeatability tolerance of the maximum FVC in that set are judged to have met the EOFE acceptability criterion. The operator should record observed signs or symptoms such as cough, wheeze, dyspnea, or cyanosis. The repeatability criteria are used to determine when more maneuvers are needed. Perform baseline spirometry. These maneuvers are unforced, except at the point of reaching RV or TLC, respectively, when extra effort is required (119). B.R.T. In addition to summary reports, the interpreter should have access to a report of all maneuvers within a testing session. Although such risks are likely to be minimal for spirometry in most patients (21), the potential risks associated with testing should always be weighed against the benefit of obtaining information about lung function (16, 17, 22). In this case, the measure of whether EOFE has been reached is for the patient to repeatedly achieve the same FVC. Purpose This guideline provides recommendations regarding best practice to support high quality spirometry practice throughout Queensland Health facilities. When contrasted with other diagnostic testing, pulmonary function laboratories in most places in the world do not have a laboratory accreditation program that mandates  practices that will help guarantee the reliability of the test results. PDF download: Chronic Obstructive Pulmonary Disease (COPD) – QPP. Events served on an advisory committee for GlaxoSmithKline; served as a consultant for AstraZeneca, Boehringer Ingelheim, CSL Behring, Fisher & Paykel Healthcare, GE Healthcare, Grifols, Mylan/Theravance, and Verona Pharma; and received research support from AMGEN, GE Healthcare, and Prolung. FEVt is the maximal volume expired by Time t seconds from Time 0 of a forced expiratory maneuver. An Official American Thoracic Society and European Respiratory Society Technical Statement. The syringe must be kept at room temperature. Domestic reprint orders: Maximal inspiration after forced expiration. Maneuvers that do not meet any of the EOFE acceptability criteria will not provide acceptable FVC measures. Spirometry is a physiological test that measures the maximal volume of air that an individual can inspire and expire with maximal effort. 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). Patient Support Programs, About Drinking water should be available. When testing children, more than eight attempts may be required because each attempt may not be a full maneuver.  var iframe = document.createElement('iframe'); For this patient, the BEV limit is 5% FVC = 0.225 L. The volume–time graph must include 1 second before the start of forced expiration (Time 0) or begin before the point of maximum inspiration, whichever occurs first. All potential conflicts of interest were disclosed and managed according to the rules and procedures of the ATS and the ERS. The operator needs to recognize the convex pattern of the flow–volume graph in such patients and distinguish it from an early termination of expiration (Figure E2). iframe.setAttribute('src', form + params); Inspection of the flow–volume graph may be added as a measure of the satisfactory start of a test. A smaller chair or a raised footstool should be provided for children and small adults. In 2005, the American Thoracic Society and the European Respiratory Socie … It should be noted that FEF25-75 is highly dependent on the validity of the FVC measurement and the degree of expiratory effort. Learn More Latest Guidelines Evidence-based clinical practice guidelines, tools and resources to help improve Formal guidelines for spirometry use were provided in 2005 through a collaboration between the American Thoracic Society (ATS) and European Respiratory Society (ERS). 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. }  iframe.setAttribute('height', 900);  var iframe = document.createElement('iframe'); The system must provide both a visual and an audible signal (single beep) when a stable end-expiratory tidal lung volume is detected or there have been 10 tidal breaths and, for expiration to RV in either IVC or EVC maneuvers, a double beep when a plateau is reached (<0.025 L in the last second) or the expiration time reaches 15 seconds. You may print one copy of this document at no charge.  iframe.style.border = '0'; The inspiratory VC (IVC) is the volume of gas slowly inspired from RV to TLC (Figure 4). For maneuvers in which stable end-expiratory tidal lung volume was not attained, IC is not reported. Patients with upper airway obstruction or neuromuscular disease are often unable to initiate a rapid increase in flow, and the BEV limit may be exceeded. A Unique User Profile that will allow you to manage your current subscriptions (including online access), The ability to create favorites lists down to the article level, The ability to customize email alerts to receive specific notifications about the topics you care most about and special offers, Standardization of Spirometry 2019 Update.  iframe.setAttribute('height', 500); 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. All disposable items, including filters, mouthpieces, noseclips, and gloves, must be disposed of at the end of the testing session. 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. However, an acceptable FEV1 measurement may be obtained from a maneuver with early termination after 1 second. Confirm patient identification, age, birth sex, ethnicity, etc. Even so, 31% considered the statement “To keep blowing even though you do not feel anything is coming out” to describe a moderate or serious issue. Clinical Guideline for Spirometry V2.1 Page 6 of 20 . Breath holding at full inflation for more than 1-2 seconds can also negatively impact the contribution of lung elastic recoil on the FEV1. The technical descriptions and documentation of the NIOSH Spirometry System ]/g, "&"); The way in which it is measured and used may vary from instrument to instrument (e.g., a simple thermometer or an internal thermistor).  iframe.setAttribute('allowTransparency', 'true'); The patient’s age, height, and weight (wearing indoor clothes and without shoes) are recorded. Operator training and attainment and maintenance of competency must be integrated in any spirometry testing service (54). Table 9. A dropped or damaged syringe should be considered out of calibration until it is checked. This will provide a measure of forced inspiratory VC (FIVC).  var iframe = document.createElement('iframe');

The back-extrapolated volume (BEV) is the volume of gas that has already been expired from maximal lung volume to Time 0 and is included in the FEV1 and FVC measurements. Figure 2. A calibration procedure determines the relationship between flow or volume transducer signals measured by the sensor and the actual flow or volume. Correct posture with head slightly elevated, Expire with maximal effort until completely empty, Inspire with maximal effort until completely full, Confirm that patient understands the instructions and is willing to comply, Attach noseclip, place mouthpiece in mouth, and close lips around the mouthpiece, Inspire completely and rapidly with a pause of ≤2 s at TLC, Expire with maximal effort until no more air can be expelled while maintaining an upright posture, Repeat instructions as necessary, coaching vigorously, Repeat for a minimum of three maneuvers, usually no more than eight for adults, Place mouthpiece in mouth and close lips around the mouthpiece, Must have BEV ≤5% of FVC or 0.100 L, whichever is greater, Must have no evidence of a faulty zero-flow setting, Must have no cough in the first second of expiration, Must have no glottic closure in the first second of expiration, Must have no glottic closure after 1 s of expiration. • There is a focus on the use of devices that measure both expiration and inspiration. Measurement of VC and IC. If the elapsed time is less than the wait time for the bronchodilator effect, then the system must provide a warning message to the operator. GOLD Spirometry Guide Download Now. x. Irene Steenbruggen. For measurements of VC and IC, the spirometer must comply with the requirements for FVC maneuvers above. Standards that are developed and updated from time to time should not limit the quest for continual improvement in the quality of lung function measurements and innovation in applying new technology (9). Grade “U” was added to denote “usable” values. The expiration should not be excessively slow, because this can lead to underestimation of VC. Table 10. In healthy patients, adequate maximal inspiratory and expiratory levels are achieved within 5–6 seconds. It is therefore important that the preceding inspiration be rapid and any pause at full inspiration be minimal (≤2 s). D.A.K. Patients should be informed that maximal inflation is unnatural; they may not have achieved it before, and it may seem somewhat uncomfortable. The height must be measured without shoes, with the feet together, standing as tall as possible with the eyes level and looking straight ahead, and the back flush against a wall or stadiometer. Spirometry is a valuable tool that provides important information to clinicians which is used together with other physical findings, symptoms, and history to reach a diagnosis.  var iframe = document.createElement('iframe'); 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. Stability is defined as having at least three tidal breaths with end-expiratory lung volume within 15% of the Vt. FEV1 and FVC measurements from a maneuver with FIVC − FVC > 0.100 L or 5% of FVC, whichever is greater, are not acceptable. 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