Portage Health Cardiopulmonary Policy. Cardiopulmonary. To provide guidelines for process and procedure with pulmonary function tests.

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1 Subject: Pulmonary Function Testing Scope: Cardiopulmonary Effective Date: 6/90 Revised: 3/99, 5/02, 6/09, 6/12 Approved by: Deb Young Approval Date: Portage Health Cardiopulmonary Policy Cardiopulmonary I. Statement of Purpose To provide guidelines for process and procedure with pulmonary function tests. II. Definitions Pulmonary Function Test -A general term that refers to a wide assortment of studies which assess various aspects of lung functions. Methacholine Challenge A drug given (methacholine) during a PFT to help differentiate a diagnosis of asthma and in certain circumstance to assist in the managing of asthma III. Statement of Policy 3.1. Pulmonary Function Test (PFT) administration is the responsibility of the Cardiopulmonary Department which, upon a physician's order, will test both in-patients and out-patients as promptly as the staffing schedule will allow If testing is to include bronchodilator therapy, the practitioner should also have an aerosol nebulizer or a metered dose inhaler, supply of tubing, a gas supply (room air or oxygen) capable of providing a flow rate of at least 5-6 lpm, and the PFT specific bronchodilator If a particular bronchodilator is not specified, 2.5 mg Albuterol nebulizer treatment for before and after pulmonary function test and should be used; for a Methacholine Challenge. Combivent MDI or Duoneb should be used Contraindication for the Methacholine Challenge is pregnancy and nursing Patient compliance is necessary to perform accurate and viable test results. Patient education must be complete and consent obtained prior to the test Scope of Service: Patient must be able to follow directions and possess the ability to consistently reproduce deep breaths; must weigh less than 500 pounds for all tests except for the Body Box Test (Plethysmography) where the weight limit is less than 350 pounds. IV. Procedure 4.1. Patient preparation prior to the test

2 4.1.1 All tests require, absence of smoking and alcohol for 24 hours prior, no eating for 2 hours prior, no coffee, tea, cola or chocolate for 6 hours prior to the test and no strenuous exercise for 30 minutes before the test The following inhalers must be held for 12 hours: Albuterol Atrovent Combivent Cromolyn Sodium DuoNeb Maxair Proventil Ventolin Intal Nasocort Nasonex The following long acting medications need to be held for up to 48 hours: Advair Brovana Dulera Flovent Pulmicort Severent Singulair Spiriva Symbicort Theophylline The following antihistamines must be held for 48 hours: Allegra Benadryl Claritin Zyrtec Validate that the above criteria is met and that the patient education is complete Turn on computer, monitor, and printer by activating master power switch Attach clean spirometry tubing to pneumotach and insert a clean, disposable mouthpiece and filter Enter system set-up information at prompt on monitor Calibration - Perform calibrations at the start of each new day of PFT testing. (See Flow and Body Box Addendum 1 and 2.) 4.6. Enter New Patient Information Enter patient data in new patient screen 4.7. Pulmonary Function Screen Test See attached Flow Volume Loops Procedure. (Addendum 3) 4.8. Before and After Pulmonary Function Test See attached Flow Volume Loops Procedure. (Addendum 3) Perform 3 viable FVC Maneuvers.

3 Administer Repeat Be Administer bronchodilator Prepare a nebulizer setup for administration of the bronchodilator, explaining the treatment technique to the patient Unless otherwise specified by the patient's physician, a 2.5 mg Albuterol sulfate in 3.0 cc NS will be administered bronchodilator as outlined in nebulizer or MDI procedure The patient must wait for 15 minutes after test before resuming study Post Bronchodilator of PFT the FVC test procedures sure to select "Post-BD" from "Pre/Post" menu for each procedure Report 4.9. Methacholine Select PHS Auto Report, if pediatric patient under the age of 18select PHS-Auto report MGH and sent to MGH for interpretation See Methacholine Challenge (Addendum 4) 4.9. PFT Complete Perform Flow Volume Loop, (Addendum 3) Perform DLCO Single Breathe Diffusion (Addendum 5) Perform Plethysmography (Addendum 6) Repeat Flow Volume Loop with Bronchodialator Post Flow Volume Loop

4 Addendum 1 Performing the Calibration Flow Calibration Vmax Spectra 1. Connect the syringe to the Mass Flow Sensor. 2. Select [F1} to begin Calibration. 3. Stroke the syringe two times and [Space Continue]. The system automatically Zero the sensor. 4. When the calibration screen is displayed, stroke the syringe 5 times, completely displayed strokes fall within the yellow target zones. When 50% or more of the stroke is in the yellow target zone the column on the right will turn green indicating the zones that have been completed. The zones must be met within 3 minutes or 15 strokes but may be completed in as few as four. When all the zone criteria have been met, the yellow target graph will automatically advance to the verification screen. 5. Stroke the syringe 5 more times, completely filling and emptying the syringe with each stroke. The first stroke will be discarded. The strokes should vary in flow rates. One stroke on or just above the lower red lines (.5 LPS). Two strokes in-between the two red, dotted lines (3LBS). One stroke above the upper red dotted lines (6 8 LPS). Again, be careful not to bang the syringe at the end of each stroke. 6. The calibration sequence will end automatically. 7. [F3] to store. ATS Standards Calibrate the Mass Flow Sensor daily. If continuous testing is being performed, calibrate the sensor every 4 hours. If a filter is used for patient testing, a filter should be in-line when calibrating. Reproducibility Standards Each of the eight strokes must be within +/- 3% of 3 liters. The strikes are averaged and compared to the predicted. The % Target values should be between 97 and 103. Important Information Vmax will automatically measure temperature and pressure. If desired, these values may be entered in the [Setup] menu. A calibration must be performed if either one of these parameters is modified.

5 Addendum 2 Performing the Calibration Body Box Calibration 1. From the [Flow Sensor Calibration] screen, select [F4]. 2. Be sure the oxygen tank is turned on, the large bore tubing (white) is connected and the body box door is closed. 3. [F1] to begin the calibration. The test will run automatically. ATS Standards Calibrate the box daily Reproducibility Standards The %Target must be between 97% and 103%. Important Information Do not touch the body box while the test is being performed.

6 Addendum 3 Flow Volume Loops Performing the Maneuver 1. Press [F1] to begin data collection. 2. Obtain 2 4 stable tidal breaths. 3. Instruct patient to inhale maximally and perform a forceful exhalation. 4. Instruct the patient to do a rapid, maximal expiration. 5. Select [End] to end test. ATS Standards The Volume of Extrapolation must be less than 5% of the Best VC, or 150 cc s. At the end of expiration, no volume change for 1 second. The expiration phase must be at least 6 seconds long. Reproducibility Standards The Best FVC and at least one other must be within 200 cc s. The Best FEV1 and at least one other must be within 200 cc s. The Best Peak Flow and at least one other must be within 10%. Best Test Criteria Largest FVC from acceptable trials. Largest FEV1 from acceptable trials. Highest PEF from acceptable trials. All other parameters come from the trial with the largest SUM of FVC + FEV1. Testing Information Maximum inspiration must be at least 1 ½ times the tidal volume. If the patient has trouble getting 1 ½ times tidal volume on inspiration, such as pediatrics or geriatrics, press [F1] anytime during the collection of the loop and the Vmax will record it as the maneuver. To obtain tidal volume loop perform at least 3 tidal breaths before the maneuver.

7 Addendum 4 Methacholine Challenge test Procedure The purpose of a Methacholine Challenge test is to determine the reactivity of a patient s airways. Pre- procedure; Check order Make sure Methacholine challenge test is ordered. Ordering physician should fax over a physician signed consent form for the Methacholine challenge. Gather necessary equipment. o Filter, nose clips, mouthpiece, and spacer. o Methacholine solutions. o Syringes. o Dosimeter. Explain Procedure. Test Procedure. Enter patient information Choose new study on Main Menu. Enter patient information Click on F3 to save entered information and move to the next screen. PFT menu (#5) Choose Provocholine Cum Dose from menu at the top of the screen on the right side labeled TEST PROTOCOL. Click on flow volume loop and perform at least 3 FVC maneuvers to establish a baseline. The baseline FEV1 must be 80% of predicted to proceed with testing. Failure by the patient to product three consistent FVC s will result in technician discontinuing the Methacholine Challenge test. Pre and post bronchodilator will be performed instead. Administer 5 breaths via dosimeter of the Koch s solution to patient. Wait two minutes. Change the blue "Pre indicator in the lower right hand corner of the screen to baseline and do an FVC maneuver. Repeat FVC if the FEV1 result is not close to the baseline FEV1 result. You will continue administering Methacholine and doing FVC maneuvers until the FEV1 results show a drop of 20% or more. So, if the FEV1 result is close to the baseline go on. Administer level of.025mg. Change the blue Baseline indicator in the lower right hand corner of the screen to pink Level 1 and do an FVC maneuver. Repeat if necessary. Continue with the same steps until you have given all the doses of Methacholine or the FEV1 drops by 20% or more. Administer four (4) puffs of Combivent via spacer or Duoneb.

8 Wait fifteen (15) minutes. Change the pink level indicator to the red Post. After 15 minutes repeat the FVC to establish the return of the patient s FEV1 to baseline or within 10% of baseline. Possible Hazards and side effects Severs bronchospasms. Flushing of the face and neck. Generalized sweating. Salivation. Transient and slight fall in blood pressure. Increased pulse rate. Irritation of the throat. Cough. Headache. Post Test Add comments to test and print results. Send one copy with face sheet to Pulmonologists at MGH for interpretation. A 2 nd copy of the preliminary report, the face sheet, permission to treat, and original order if the patient brought it in to Medical Records.

9 Addendum 5 Single Breath Diffusion [DLCO] Performing the maneuver From main menu chose pulmonary function then choose single breath DLCO Press [F1] to begin test. This will start the automatic calibration it takes about 45 seconds. The screen will automatically go to the DLCO testing screen. Instruct the patient to breathe normally, them exhale maximally. During expiration, select [F12]. A [Continue to expire] message will appear. After the screen changes, instruct the patient to perform a fast maximal inspiration and then to hold their breath. Have the patient relax against the shutter, but remind them to keep their lips tight. After approximately 10 seconds the balloons will deflate, then instruct the patient to exhale completely at a moderate rate of speed. The test will end automatically. ATS Standards The patient IVC must be at least 90% of the best VC value. The Breath Hold Time should be 10 seconds and must be within 9 to 11 seconds. During Breath Hold have the patient relax against the shutter, or have a slightly negative pressure against the shutter. The [Patient Dead Space Volume] in the [Setup] screen, should be recorded at 1cc per pound of the patient s ideal weight. The Mead Jones breath hold time calculation method should be used. Reproducibility Standards The DLCO values must be within 10% of each other. Best Time Criteria DLCO Average of all trials VA Average of all IVC trials. IVC Average of all trials Testing Information This test is reported in STPD. Wait 5 minutes between trials. If DLCO is performed after a Nitrogen Washout, the same rule applies (5 minutes). Any oxygen in the lung above 21% will cause a decrease in the DLCO value. The patient should be sitting quietly for 5 minutes before starting this test.

10 If there is a hemoglobin (Hb) or carboxy-hemoglobin (COHb) value on this patient, it may be entered in the Patient Demographics [Other] or in DLCO under the pull down menu [Test]. The [Extra Dead Space Volume] should be entered for each item connected to the Mass Flow Sensor. If using a Microguard Filter only, enter.050 in this box. To add a Sensormedics rubber mouthpiece in addition to the Microguard add.030 more making the total extra deadspace volume.080. Use the [F2] delete key on trials with questionable values since the DLCO, VA, and IVC are the average of all the trials. The computer will place the collection box at a Discard value of 750 ccs and a Collection value of 1,000 ccs. If the patients VC is less the 2 liters, the Discard value can be dropped to 500ccs. The placement of the collection box should be placed anywhere on the vertical portion of the graph, representing the anatomical deadspace of the patient. The patient s IVC should not reach TLC in less than 1 second, but before 2 ½ seconds into the maneuver. The first green dotted vertical line on the graph is the 2 ½ second mark. For patients with chronic lung disease, this may be increased to 4 seconds.

11 Plethysmography Addendum 6 Performing the maneuver Before performing the tests below, make sure the patient has been inside the box with the door shut for at least one minute. This ensures that the box is thermally equilibrated. The 22 mm clear gas hose should be disconnected from the balloon valve assembly, while the large white hose should remain attached from the box to the right side of the balloon valve assembly. Panting Raw/FRC with Vtg 1. From the main menu, select pulmonary function then select plethysmography 2. Press [F1] to begin data collection. 3. Observe four stable tidal breaths. After the red dotted ERV line appears, instruct the patient to do a maximum inspiration, maximum expiration, then return to normal tidal breathing. 4. Press [F1] to begin the Raw/vtg maneuver. 5. Instruct the patient to begin panting. Panting is one to three times per second, around 50 cc s of volume. 6. The patient will pant for 8 seconds through an open circuit. Then, the circuit will become occluded and the patient will pant for eight more seconds. The circuit will open automatically after the second set of pants. Warn the patient that during the maneuver the circuit will become occluded for a few seconds. 7. Press [End]. Resting Raw with Vtg (Patient is unable to pant) 1. Press [F1] to begin data collection. 2. Observe four stable tidal breaths. After the red dotted ERV line appears, instruct the patient to do a maximum inspiration, maximum expiration, then return to normal tidal breathing. 3. Press [F1] to begin the Raw/vtg maneuver. FRC PL (Vtg) Resting 1. In the RAW and VTG protocol set the collection method to none for Raw and resting for Vtg. [F3} store. 2. Press [F1] to begin data collection. 3. Observe four stable tidal breaths After the red dotted ERV line appears, instruct the patient to do a maximum inspiration, maximum expiration, then return to normal tidal breathing. 4. Press [F1] to begin the Vtg maneuver. 5. The circuit will occlude. Instruct the patient to take one inspiratory breath and then breathe normally. 6. Press [End}. ATS Standards There are no standards for this maneuver. Reproducibility Standards The Raw s must be within 10% of each other. The FRC PL s must be within 10% of each other. The largest VC and at least one other must be within 200 cc s of each other. Best Test Criteria VC Largest from FVC, VC, or FIVC from any trial FRC PL Average from all trials of FRC ERV Average of all trials of ERV

12 IC An average of all trials Vt Average of all trials of Vt RAW Average of all trials of Raw Vtg Average of all trials of Vtg. Testing Information The Vtg loops must be evaluated after each trial by selecting the [F7] key. The Raw loops must be evaluated after each trial by selecting the [F7] key. The slope for each of the Vtg and Raw loops must be placed in the proper position. The correct position is parallel to both sides of the loop, down the center of the loop between the dotted lines. Any loops that are not acceptable must be deleted using the [F2] key so that they are not included in the averaging. For patients that are showing a rise in their ERV baseline, the [F9] key can be used to adjust the end-tidal point. Note that this is not a system artifact but a physiologic state. Another solution to this situation is to do the test by separating the VC and the FRC maneuvers. Remember to select [FRC (Vtg) Only] in the plethysmography [Test Setup] screen, if this is being done. In the [Test Setup] screen, the [Filter Raw] should be set to [0.050] for the resistance of the filter. In the [Test Setup] screen, the [Total Deadspace] should be entered in cc s. If you are using the Microguard filter 50 cc s should be entered. If there is also a rubber mouthpiece add 30 more cc s. The most important procedure to perform correctly is the panting maneuver. The maneuver should be done at a rate of 1 to 3 times per second, with a volume of not more than 50 cc s. The most common problem is patients panting too deeply. Instruct the patient to pant baby puffs of air. If patients are have a difficult time Panting correctly, switch to the Resting modes. The software can handle patient of up to 500 pounds. The body box can handle a patient of up to 350 pounds as long as their shoulders are not touching the sides of the box. If any part of the body is touching the box, the data will be invalid. The Plexiglas windows CANNOT be cleaned with ammonia or alcohol, as it will damage the finish.

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