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Reprinted from the July 1995 issue of RESPIRATORY CARE [Respir Care 1995;40(7):761–768]

AARC Clinical Practice Guideline

Infant/Toddler Pulmonary Function Tests

ITPFT 1.0 PROCEDURE:

Infant/toddler pulmonary function tests (ITPFTs)

ITPFT 2.0 DESCRIPTION/DEFINITION:

2.1 Infant/toddler pulmonary function tests measure a variety of pulmonary variables in subjects who are generally too young to perform, comprehend, or comply with necessary instructions for conventional pulmonary diagnostic procedures (eg, forced vital capacity, slow vital capacity, panting airways mechanics).
2.2 Subjects are typically tested while sleeping or sedated, may have an artificial airway in place, and may be either spontaneously breathing or mechanically ventilated.
2.2.1 Sedation is required in instances in which the subject's agitation or movements make it difficult to acquire meaningful information.(1)
2.3 ITPFTs may include measurements of:(2,3) static and dynamic pulmonary mechanics (total respiratory system compliance [Crs] and lung compliance [CL], total respiratory system resistance [Rrs] and airway resistance [Raw]), tidal-breathing flow-volume loops, gas dilution/elimination FRC (FRCHe and FRCN2), plethysmographic FRC (FRCpleth), rapid thoracoabdominal compression ("squeeze"/"hug") technique for partial expiratory flow-volume curves, and the rapid-deflation technique for expiratory flow-volume curves.
2.3.1 Although these procedures are intended primarily for neonate and infant evaluation, some older subjects may be successfully evaluated, if appropriately sized equipment is employed and methodology limitations are well understood.
2.3.2 Newer techniques, such as methods incorporating inflation of the subject to total lung capacity (TLC) prior to hugging, show promise in assuring maximal maneuvers and obtaining consistent vital capacity (VC) information.(4-6) Recent findings employing oscillation, while simultaneously recording esophageal pressures, provide evidence that flow limitation is being reached. Additionally, use of the interrupter technique to assess airway obstruction is being evaluated.(7) However, because these techniques are currently (1995) in the investigational stages of their development, they will not be addressed in this guideline.

ITPFT 3.0 SETTING:

Testing may be performed, in a variety of settings including, but not limited to hospital laboratories, intensive and intermediate care units, physician offices, and clinics provided infants undergoing conscious sedation can be appropriately monitored in the specific setting.(1,9) The testing site should be adapted to assure the subject's safety during testing.(1)

ITPFT 4.0 INDICATIONS:

ITPFTs may be indicated
4.1 to aid in diagnosis(9) of lung disorders (eg, reactive airways disease);
4.2 to follow the natural history of lung growth, or diseases presenting in infancy(10,11) (eg, cystic fibrosis);
4.3 to evaluate therapeutic responses(12,13) (eg, to medication or physical or respiratory interventions);
4.4 to allow for prediction of risk of subsequent pulmonary dysfunction based upon initial testing.(14)

ITPFT 5.0 CONTRAINDICATIONS:

5.1 Although absolute contraindications to performing ITPFTs have not been described in the medical literature, prior to initiating ITPFTs the technologist should evaluate the patient. Clinical judgment and/or caution should be exercised if the client presents with
5.1.1 active pulmonary bleeding,
5.1.2 open chest wound,
5.1.3 untreated pneumothorax.
5.2 ITPFTs are relatively contraindicated when:
5.2.1 Temporary interruption of ventilatory support will worsen the patient's medical condition and/or pulmonary compliance beyond the benefit of the information gained from performing ITPFTs.
5.2.2 Sedation effects(8) might result in untoward clinical events in patients with cardiopulmonary and/or neurologic disease presenting with conditions for which sedation is contraindicated unless airway patency/protection is assured and maintained.
5.2.2.1 central hypoventilation;
5.2.2.2 pre-existing central nervous system depression;
5.2.2.3 obstructive sleep apnea; or in patients in whom one or more of the following is present:
5.2.2.4 severe obesity;
5.2.2.5 esophagitis or gastritis;
5.2.2.6 hepatic or renal dysfunction;
5.2.3 The level of patient sedation/paralysis is inadequate;
5.2.4 The patient is uncooperative or combative.

ITPFT 6.0 PRECAUTIONS/HAZARDS AND/OR COMPLICATIONS:

Although ITPFTs are generally safe procedures, the following untoward events may occur:
6.1 vomiting with aspiration with consequent apnea and laryngospasm and/or bronchospasm
(The forced deflation technique requires tracheal intubation.(15))
6.2 pneumothorax
6.3 increased intracranial pressure
6.4 loss of airway patency
6.5 transmission of contagion via improperly cleaned equipment or as a consequence of the inadvertent spread of droplet nuclei or body fluids (patient-to-patient or patient-to-technologist)
6.6 oxygen desaturation due to
6.6.1 a worsening of ventilation-to-perfusion mismatch and hypoventilation as a consequence of sedation and/or positioning;
6.6.2 interruption of oxygen therapy or failure to preoxygenate the patient prior to performing the forced deflation technique;
6.6.3 temporary loss of distending pressure.

ITPFT 7.0 LIMITATIONS OF METHODOLOGY/ VALIDATION OF RESULTS:

Large intra- and interlaboratory differences in measured ITPFTs and in percent of predicted values have been observed. These differences are attributed to variations in patient preparation, testing techniques, equipment, computational algorithms, and errors in gas analysis.(1) The choice of equipment, equipment calibration, and tester training may also affect the measured values. Technique standardization and validation is required.(1)
7.1 Typical methods used for ITPFTs and their limitations are(15,16)
7.1.1 Rapid thoracoabdominal compression (RTC) squeeze/hug technique.
7.1.1.1 Increased upper airway resistance may interfere with the accuracy of intrathoracically determined flows.
7.1.1.2 Air flow may be affected by upper airway obstruction and nasal compression or by head and neck positioning. (Subject positioning must minimize pharyngeal narrowing.)
7.1.1.3 Flows should be referenced to lung volumes.(17)
7.1.1.4 Reflex glottic closure (complete or partial) may limit flow.
7.1.1.5 Variations in end-expiratory levels, or functional residual capacity (FRC), may affect measurements 'at FRC' making therapeutic evaluations (eg, efficacy of bronchodilator or surfactant) difficult.
7.1.1.5.1 Sleep state and subject positioning affect FRC.(1,15)
7.1.1.5.2 Repeated hugs alter true FRC. Rest intervals must be provided between serial measurements.
7.1.1.6 Unless actual flow limitation (defined as no further increase in flow despite increasing pressure) is reached, intra- and intersubject comparisons are problematic.
7.1.1.6.1 Whether flow limitation can actually be reached (using this technique) and the best method for determining flow limitation is controversial.
7.1.1.6.2 Hug pressures may range < or = 40 to > 80 cm H2O.(17) However, if too little pressure is transmitted to the pleural space, flow limitation will not be achieved. Conversely, excessive pressures may alter the shape of the curve, via negative effort dependence.(17,18)
7.1.1.7 The flow-volume relationship produced by the RTC technique represents a small portion of the entire MEFV curve.(19) (Inspiratory efforts during squeeze may reduce expiratory volumes and/or flows.)
7.1.1.8 Improperly sized and positioned `hug' bag.(17,20,21)
7.1.1.9 Pneumotachometer with inappropriate flow range.
7.1.2 Compliance and resistance measurements obtained by various techniques may be difficult to interpret,(22) and further work is required to define their validity in normal infants and those with lung disease. For example, assumptions regarding linearity of lung compliance and resistance may not necessarily be valid with disease states.
7.1.2.1 Evaluation of lung compliance requires placement of an esophageal balloon to measure transpulmonary pressure.
7.1.2.1.1 Inappropriate balloon placement and other factors (such as distortion due to paradoxical chest-wall movement) invalidate transpulmonary pressure measurements.
7.1.2.1.2 The instability/flexibility of the premature infant's chest wall may invalidate results.
7.1.2.2 Evaluation of respiratory system compliance is not valid unless ventilatory muscles are relaxed (ie, paralyzed, highly sedated, or demonstrating effective Hering-Breuer reflex).
7.1.2.2.1 Effects of sleep deprivation, sedation, anesthetics, and muscle relaxants may alter FRC, bronchomotor tone, and upper airway resistance.
7.1.2.2.2 Pneumotachometers and occlusion valves increase system dead space and resistance, which may alter tidal volume, respiratory rate, and FRC.
7.1.2.2.3 Leaks around artificial airways and masks lead to erroneous measurements.
7.1.2.2.4 Single breath occlusions should be referenced to lung volume (due to changing FRC). Multiple occlusion procedures provides an average expiratory compliance over a range of tidal volumes.
7.1.2.3 Measurements of Raw and Rrs may not be equivalent in subjects having either upper or lower airway obstruction.(23)
7.1.3 Limitations of gas dilution/elimination methods (eg, helium-dilution or multiple-breath nitrogen washout [MBNW] techniques, FRCHe and FRCN2, respectively) to measure FRC include
7.1.3.1 system dead-space must be precisely sized to the patient being studied;
7.1.3.2 MBNW results are questionable with FIO2 > 0.7 to 0.8;(15)
7.1.3.3 background gas flow must exceed the subject's peak inspiratory flow;
7.1.3.4 leaks invalidate measurements (tight mask seals, cuffed ET tubes, or cricoid pressure should be incorporated);
7.1.3.5 analyzer response time, lag time between measuring flow and gas concentration, and sampling rate affect results;
7.1.3.6 the number of tests performed and test variability.
7.1.3.6.1 Agreement on test reproducibility criteria (in the clinical arena) and the length of time required to wait between sequential FRC measurements is currently lacking (1995).(24)
7.1.3.6.1.1 Recommendations based on clinical experience include performance of at least 6 FRC measurements, discarding the highest and lowest values and reporting the average value of the 4 to 5 FRCHe or FRCN2 measurements, that have a coefficient of variation of < or = 8%. (See also 9.0 Assessment of Outcome/Test Quality)
7.1.3.6.1.1.1 Because infants with lung disease frequently have a high degree of variability in their FRC measurements, reproducibility criteria should exceed those published for adults(19) (reporting the average of at least two FRCHe values that are within 10% of each other(15))
7.1.3.6.1.1.2 The number of sequential FRCN2 tests (ie, 3 to 5) and corresponding mean coefficient of variation (CV) between tests (3.9% [range = 0.2-9.0%; subjects = 50] to 11.9% [range = 2.8 25.3%; subjects = 25]) have been described in the research setting.(25,26) Reproducibility of multiple FRCHe measurements in healthy infants has been reported with a mean CV ± SD of 4 ± 2.8%.(27)
7.1.3.6.1.2 In the clinical setting, a reasonable waiting period, between sequential measurements, may be equal to the time it took to perform the last FRC measurement
7.1.3.6.1.2.1 A 5-minute wait interval, between consecutive FRCN2 measurements, has been reported(26) in a research study.
7.1.3.6.1.3 To ensure testing continuity, institutional ITPFT policies and procedures must contain statements about the validation methodologies used for determining and reporting FRC values.
7.1.3.7 Recommendations are lacking for determining equilibration criteria.
7.1.3.8 Technique underestimates FRC when compared to FRCpleth.(25,28)
7.1.3.9 Sleep stage(29) and sedation may affect FRC level.
7.1.3.10 Timing and speed of valve closure for switch-in/switch-out time should be standardized. The proficiency of the technologist for effectively switching-in at FRC is critical because the derived value is dependent upon this ability.
7.1.4 Tidal breathing flow-volume loops may provide limited information if used alone.(30)
7.1.5 Forced deflation technique:
7.1.5.1 Procedure is suitable only for patients with an artificial airway,(9) but leaks around the endotracheal tube cuff results in inaccurate measurements
7.1.5.2 Pneumotachometers must be calibrated according to the gas densities encountered during testing.
7.1.5.3 Endotracheal tube size may alter flows.
7.1.5.4 The effects of altering volume history on lung function needs to be better delineated.
7.1.5.5 Patients need to be paralyzed or deeply sedated.
7.1.5.5.1 Sedation levels may affect FRC.
7.1.5.5.2 Pharmacologic agents (anesthetics, muscle relaxants) may affect testing (ie, alter bronchomotor tone).
7.2 Little has been published on ITPFT predicted values or reference equations. The choice of reference equations may affect the final interpretation of measured values.
7.3 Validation of the testing technique/equipment may include but is not limited to:
7.3.1 Accuracy of the volume or flow-measuring device and ability to maintain accuracy with varying gas concentration. The accuracy of the calibrating syringe's standard volume should be assessed on a regular basis and revalidated annually or any time accuracy is suspect.
7.3.2 Gas analyzers should have a 2-point calibration before each test, and linearity should be formally checked (using a minimum of 3 points) at least every 6 months. Analyzers should be maintained according to manufacturer recommendations.
7.3.3 The creation of predicted reference ranges is difficult in the average laboratory. The recognition that there is little published data cannot be overemphasized at this point in the evolution of the ITPFT field. 'Normal' standard subjects may be used to establish an acceptable intrasubject coefficient of variation(31) and serve as a quality control population.

ITPFT 8.0 ASSESSMENT OF NEED:

Determination that valid indications are present.

ITPFT 9.0 ASSESSMENT OF OUTCOME/ TEST QUALITY:

Outcome and test quality are determined by ascertaining that the desired information has been generated for the specific indication(s) and that validity and reproducibility have been assured. Each laboratory should standardize procedures and demonstrate intertechnician reliability.(1) Test results can only be considered valid if they are derived according to and conform to established laboratory quality control and quality assurance protocols. These protocols should address test standardization and reproducibility criteria that include the methodology used to derive and report the ITPFTs.
9.1 ITPFTs performed for the listed indications are valid only if the instrumentation functions acceptably and the maneuvers are obtained in an acceptable, reproducible fashion.
9.2 Report of test results should contain a statement by the technician performing the test about test quality and if appropriate, which recommendations were not met.

ITPFT 10.0 RESOURCES:

10.1 Equipment: Equipment specifications should conform to recognized standards (eg, American Thoracic Society spirometry standards32) and where applicable, be FDA approved.
10.1.1 Distinctive pneumotachograph, helium analyzer (katharometer) and nitrogen analyzer performance specifications. Appropriate use of gas analyzers is dependent upon the methodology employed.
10.1.2 Gases must be medically certified.
10.1.3 Size-appropriate resuscitation equipment (including appropriate pharmacologic agents) must be readily available.(1)
10.1.4 Sedation monitoring equipment must be available (eg, continous pulse oximetry with pulse rate).(1)
10.2 Personnel:
10.2.1 ITPFTs should be performed under the direction of a physician trained in infant pulmonary function testing methodologies (including limitations and applications). The value of ITPFT results are compromised when a test is administered and/or interpreted by inadequately trained personnel.
10.2.2 Testing personnel should be specifically trained (with verifiable training and demonstrated competency) in all aspects of ITPFTs, including equipment theory of operation, quality control, and test outcomes relative to diagnosis and/or medical history. Proficiency must also be demonstrated relative to their ability to calibrate equipment, apply ancillary devices to the client, perform the test, monitor the patient and determine the quality of the test.
10.2.2.1 Testing personnel should also be trained in basic life support.(1)
10.2.2.2 At least one of the following credentials is recommended: CRTT, RRT, CPFT, RPFT, LPN, RN, MD, DO.

ITPFT 11.0 MONITORING: (Also see Section 9.0 ASSESSMENT OF TEST QUALITY)

The following should be monitored during ITPFT determinations
11.1 Test data of repeated efforts (ie, reproducibility of results) to ascertain the validity of the results (The final report should contain a statement about testing conditions and test quality.)
11.2 The final report should contain the requested parameters and lung-volume corrected values (if applicable).
11.3 The patient for any adverse effects of testing
11.3.1 Infants undergoing conscious sedation should be appropriately monitored,(8) with sedative information included in the final report.
11.3.2 Patients on supplemental oxygen may require periods of time to rest (on oxygen) between trials.

ITPFT 12.0 FREQUENCY:

The frequency at which ITPFT measurements are repeated depends on the clinical status of the patient and the indications for performing the test.

ITPFT 13.0 INFECTION CONTROL:

Infant/toddler pulmonary function tests are relatively safe procedures, but the possibility of cross-contamination exists, either from the patient-patient or patient-technologist interface.
13.1 Universal Precautions (as published by the Centers for Disease Control) should be applied in all instances in which there is evidence of contamination with blood (eg, pneumotachometers and adapters). Although Universal Precautions do not apply to saliva or mucus unless it contains blood, other potentially hazardous organisms may be present in these fluids even in the absence of blood, and the appropriate use of barriers and hand washing are recommended.(33,34)
13.2 Due to the nature of some ITPFT maneuvers and the possibility of coughing when the test is performed by subjects with active infection with M tuberculosis or other airborne organisms, the following precautions are recommended:(35)
13.2.1 If a maneuver is likely to stimulate or induce a cough, disposable gloves, protective outerwear, along with masks (which comply with OSHA requirements) and protective eyewear should be utilized. This personal protective equipment is also to be used when testing patients with known or suspected, potentially infectious airborne disease(s).
13.2.2 The room in which ITPFTs are performed should meet or exceed the recommendations of U.S. Public Health Service for air changes and ventilation. The most desirable arrangement may be to maintain a specially ventilated area in the testing department for isolation patients.
13.3 Any parts of the system that come into contact with the subject should be disposable or sterilized between patients. If sterilization is not feasible, then high-level disinfection should be performed.(36) All cleaning should comply with manufacturer recommendations. Several pneumotachometers and/or valving assemblies may be required if cleaning cannot be performed in a timely manner between patients.(1)
13.4 The use of bacterial filters is controversial.(36)
13.4.1 Attachment may result in added system dead space and may invalidate pneumotachometer accuracy by increasing total system resistance of the apparatus.
13.4.2 Filter resistance should be subtracted from Raw (and related parameters)
13.4.3 If filters are used in gas-dilution procedures, their volume should be subtracted when FRC is calculated.(24)
Infant & Toddler PFT Guidelines Committee:

Kevin Shrake MA RRT, Chairman, Springfield IL
Sue Blonshine BS RRT RPFT, Lansing MI
Robert A Brown BS RRT RPFT, Madison WI
Michael J Decker BS RRT, Cleveland OH
Gregg L Ruppel MEd RRT, St Louis MO
Jack Wanger MBS RRT RPFT, Denver CO
Deborah K White BS RRT RPFT, Consultant, St Louis MO

REFERENCES
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Reprinted from the July 1995 issue of RESPIRATORY CARE [Respir Care 1995;40(7):761–768]

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