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Methacholine Challenge Testing: 2001 Revision & Update

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Methacholine Challenge Testing: 2001 Revision & Update AARC GUIDELINE: METHACHOLINE CHALLENGE TESTING: 2001 REVISION & UPDATE AARC Clinical Practice Guideline Methacholine Challenge Testing: 2001 Revision & Update MCT 1.0 PROCEDURE: 4.5 the need to assess response to therapeutic Methacholine challenge test. This guideline does interventions;2 not address other bronchial challenges (eg, his- tamine, exercise, occupational exposures, specific MCT 5.0 CONTRAINDICATIONS: antigens, isocapnic hyperventilation.) 5.1 Absolute contraindications are: 5.1.1 ventilatory impairment: FEV1 <50% MCT 2.0 DESCRIPTION/DEFINITION: of predicted or < 1.0 L;2 [This may be a 2.1 The methacholine challenge test is one relative contraindication depending on the method of assessing airway responsiveness. In age or size of the patient or on the pres- this test, the patient inhales an aerosol of one or ence of a restrictive lung disorder (re- more concentrations of methacholine. Results duced forced vital capacity, or FVC, with of pulmonary function tests (eg, spirometry, a relatively normal FEV1/FVC)]; specific conductance) performed before and 5.1.2 heart attack or stroke within the pre- after the inhalations are used to quantitate re- vious 3 months;1,2 sponse. This guideline applies to adults and 5.1.3 known aortic or cerebral aneurysm;1,2 children capable of adequately performing 5.1.4 uncontrolled hypertension [The spirometry or body plethysmography and of co- American Thoracic Society (ATS) sug- operating during the course of the challenge. gests systolic pressure > 200 and/or dias- 2.2 A positive test is defined as a decrease from tolic pressure >110 mm Hg.].2 the baseline forced expiratory volume in the 5.2 Relative contraindications are: first second (FEV1) or of the postdiluent FEV1 5.2.1 ventilatory impairment: FEV1 > value of 20%, or of a decrease in specific con- 50% or > 1.5L but < 60% of predicted;2 ductance of 35-45% from the baseline or post- 5.2.2 inability to perform spirometry of diluent value.1-4 acceptable quality;2 5.2.3 significant response to the diluent, if MCT 3.0 SETTINGS: administered (ie, > 10% fall in FEV1 from Possible settings include: baseline);10 3.1 pulmonary function laboratory;RETIRED 5.2.4 upper- or lower-respiratory-tract in- 3.2 clinic or physician’s office; fection within previous 2 to 6 weeks;1,11,12 3.3 field site (eg, occupational setting or work- 5.2.5 current use of cholinesterase-inhibitor place). medication (for myasthenia gravis); 2 5.2.6 pregnancy (The effect of metha- MCT 4.0 INDICATIONS: choline on the fetus is unknown.);13 Indications for testing include: 5.2.7 lactation;13 4.1 the need to exclude a diagnosis of airway 5.3 Failure to withhold medications may affect hyperreactivity (ie, asthma);1,2,5-9 the methacholine challenge test. Recommended 4.2 the need to evaluate occupational asthma;1,2 periods for withholding medications are gener- 4.3 the need to assess the severity of hyperre- ally based on their duration of action.1,2 Labora- sponsiveness;1,2 tories may choose to develop a simplified with- 4.4 the need to determine the relative risk of de- holding schedule that makes allowances for any veloping asthma;2 of the following used by the patient: RESPIRATORY CARE • MAY 2001 VOL 46 NO 5 523 AARC GUIDELINE: METHACHOLINE CHALLENGE TESTING: 2001 REVISION & UPDATE Agent Withholding Time not be sensitive enough or specific short-acting inhaled 6-8 hours enough to detect response, and other mea- bronchodilators surements such as airways resistance long-acting inhaled 48 hours (Raw) and/or specific conductance (sGaw) bronchodilators (eg: salmeterol, may be used. Differences of opinion exist formoterol) regarding the spirometric values that best anticholinergic aerosols 24 hours track response in particular airways.1,2,24 (eg: ipratropium) 7.1.2 Deep inspiration taken while perform- tiotropium up to 1 week14 ing spirometry variably alters bronchial disodium cromoglycate 8 hours tone and may result in either bronchocon- nedocromil 48 hours striction or bronchodilatation.25-27 oral beta2-adrenergic agonists 24 hours 7.1.3 Poor patient effort during pul- theophyllines, depending on 12-48 hours monary function testing can produce specific preparation2 false-positive results and make interpreta- leukotriene modifiers 24 hours2 tion more difficult or impossible. Results corticosteroids, inhaled or oral Duration of effect from spirometry should be acceptable ac- (may decrease is unknown but cording to the most recent ATS recom- hyperresponsiveness) may be prolonged.15,16 mendations, and the quality of the flow- 5.4 Foods: Ingestion of coffee, tea, cola drinks, volume curves should be examined after chocolate, or other foods containing caffeine each maneuver.2,28 may decrease bronchial responsiveness. These 7.1.4 Spirometry should be performed ac- substances should be withheld on the day of test. cording to the current acceptability guide- 5.5 Other factors that may confound results in- lines of the ATS. Alternatively, the expira- clude: tory maneuver can be shortened to about 2 5.5.1 smoking,17 seconds after the methacholine doses are 18 5.5.2 occupational sensitizers, inhaled if FEV1 is the only outcome mea- 5.5.3 respiratory infection,11,12 sure. If this shortened expiratory maneu- 5.5.4 specific antigens,19 ver is used, care should be taken to assure 5.5.5 vigorous exercise.20-22 (Performing that the inspiration is maximal.2 After the other bronchial challenge procedures or inhalation of diluent (if used) and of each exercise testing immediately prior to dose of methacholine, FEV1 measure- methacholine challenge may affect inter- ments should be made at 30 and 90 sec- pretation.) onds after the last inhalation. The time in- terval between doses should be standard- MCT 6.0 HAZARDS/COMPLICATIONS: ized at 5 minutes to keep cumulative Possible hazards or untoward reactions include: effect constant. 6.1 bronchoconstriction, hyperinflation,RETIRED severe 7.2 A limitation of the method is the variability coughing; due to the effects of various factors including 6.2 hazards associated with spirometry, such as medications, time of day, and differences in dizziness, light-headedness, chest pain;23 technique and equipment. 6.3 possible exposure of testing personnel to 7.3 Inconsistencies in technique and equipment provocative substance. can affect the amount of agonist reaching the airways and, thus, the subject’s response— MCT 7.0 LIMITATIONS OF METHOD & making meaningful interpretation difficult or VALIDATION OF RESULTS: impossible. Factors influencing response that 7.1 Limitations of pulmonary function testing must be controlled and held constant across used to quantitate response including intralabo- testing include nebulizer output and particle ratory variability for each pulmonary function size, volume inhaled, length of breath-hold, and test variable: inspiratory flow.2,29,30 7.1.1 In some patients, spirometry may 7.4 If clinical suspicions are not confirmed by 524 RESPIRATORY CARE • MAY 2001 VOL 46 NO 5 AARC GUIDELINE: METHACHOLINE CHALLENGE TESTING: 2001 REVISION & UPDATE one test, additional tests may be indicated. scribed in the NCCLS GP26-A A Quality System 7.5 The final test report should include: Model for Health Care.31 (Fig. 1) The document de- 7.5.1 PC20FEV1 (ie, the provocative con- scribes a laboratory path of workflow model that in- centration that causes a 20% fall in FEV1). corporates all the steps of the procedure. This pro- 7.5.2 comment on the adequacy of spiro- cess begins with patient assessment and the genera- metric effort and quality of other mea- tion of a clinical indication for testing through the surements; application of the test results to patient care. The 7.5.3 notation regarding medications quality system essentials defined for all health care known to confound interpretation of re- services provide the framework for managing the sults (Section 5.3) taken by the patient path of workflow. A continuation of this model for prior to testing; respiratory care services is further described in 7.5.4 presence or absence of other factors NCCLS HS4-A A Quality System Model for Respi- known to confound interpretation of re- ratory Care.32 In both quality models the patient is sults (Section 5.4); the central focus. 7.5.5 clinical signs and symptoms and 9.1 General considerations include: clinical appearance during the course of 9.1.1 As part of any quality assurance pro- the test and after final dose; gram, indicators must be developed to 7.5.6 bronchodilator and dose adminis- monitor areas addressed in the path of tered at end of challenge; workflow. 7.5.7 tabular display of data for each test 9.1.2 Each laboratory should standardize phase including response to bronchodila- procedures and demonstrate intertechnol- tor at end of challenge. ogist reliability. Test results can be con- sidered valid only if they are derived ac- MCT 8.0 ASSESSMENT OF NEED: cording to and conform to established lab- Need is established by documenting in a subject the oratory quality control, quality assurance, presence of one or more of the listed indications or and monitoring protocols. as established by progression through the institu- 9.1.3 Documentation of results, therapeu- tion’s or the laboratory’s protocol decision tree. tic intervention (or lack of) and/or clinical decisions should be placed in the patient’s MCT 9.0 ASSESSMENT OF TEST QUALITY medical record. & VALIDITY OF RESULTS: 9.1.4 The type of medications, dose, and The consensus of the committee is that all diagnos- time taken prior to testing and the results tic procedures should follow the quality model de- of the pretest assessment should be docu- RETIREDPulmonary Diagnostics Path of Workflow Pretest Testing Session Post-test Quality Patient Assessment Patient Training Results Report Test Request Test Performance Interpretation System Patient Preparation Results Review and Selection Clinical Consult Essentials Equipment Preparation Patient Assessment for Further Testing Organization Personnel Information Management Equipment Information System Purchasing/ Inventory Process control Documents/ Records Occurence management Quality system essentials Internal apply to all operations assessment in the path of workflow Process improvement Service and Satisfaction Fig.
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