Medical Policies - Medicine
Computerized Wheeze Detection/Monitoring
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Computerized wheeze detection/monitoring, including intermittent or continuous measurement, recording and interpretation of data, is considered experimental, investigational and/or unproven for the diagnosis and/or management of asthma, chronic cough and other respiratory disorders.
Abnormal breathing sounds (e.g., crackles, rhonchus, and wheezing sounds) are normally considered as indicator symptoms in chronic respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis, etc. (1) For these diseases, unnecessary secretions (such as sputum) is produced in the respiratory tract and causes chronic inflammation leading to airway obstruction. During acute exacerbation of airway obstruction, airflow velocity is changed when the air flows from the normal airway into the narrowing airway, producing abnormal breathing sounds, such as wheezes.
Currently, investigation of breathing sounds is based mainly on the auscultation approach. (1) Although this method is simple, convenient, and non-invasive, it is also subjectively dependent on the experience of the operator, the variability of the human auditory system and the type of stethoscopes used. For these reasons, the use of computerized wheeze detection has been proposed as a diagnostic tool in the evaluation of lung sounds.
A number of computerized wheeze detection devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process, including but not limited to the following:
• Approved by the FDA in 1998, the PulmoTrack™ (Respiri Limited, previously known as iSonea Ltd. and KarmelSonix Ltd.) is a computer-based electronic stethoscope that utilizes up to five contact sensors simultaneously to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea and thorax, and subsequently provides high fidelity audio outputs, visual displays and printed reports. PulmoTrack is indicated for use “by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in a pulmonary function testing environment when there is a need to perform an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds.” (2)
• The Personal Wheezometer™ (Respiri Limited, previously known as iSonea Ltd. and KarmelSonix Ltd.) was approved by the FDA in 2009. Intended to be a home version of the PulmoTrack, the device outputs a wheeze-rate score based on the amount of wheezing detected in a given time. (3)
• FDA approval for the Wholter™ (Respiri Limited, previously known as iSonea Ltd. and KarmelSonix Ltd.) was granted in 2010. This device is intended to acquire, record, and store ambulatory respiratory activity from patients for up to 24 hours. It works in concert with the PulmoTrack™ Series for playback, review, analysis, editing and printing of respiratory data. Wholter is indicated for, but not limited to, recording of signals that reflect symptoms such as wheeze and cough. (4)
Respiri Limited is currently developing the AirSonea® device, which builds on the company's previous device, the Wheezometer. The AirSonea uses a proprietary sensing method the company defines as acoustic respiratory monitoring. This method of monitoring measures a patient's wheeze rate before and after tests with a bronchodilator to demonstrate the effectiveness of asthma treatments. The device itself is handheld for clinical or home use and acts much like a stethoscope a physician uses when listening to a patient’s lungs. By placing the sensor on the trachea [windpipe] for 30 seconds of normal breathing, the device can record and then analyze breath sounds for the presence of wheezing. The recorded breath sounds are analyzed with advanced algorithms to detect, quantify and measure wheeze, an important sign of air flow obstruction in asthma. This product is currently unavailable for sale in the United States. (5)
This medical policy was originally created in 2011 and has been updated regularly with literature searches, most recently through May 7, 2018. Following is a summary of the key literature.
Bentur et al. (2004) conducted a study to evaluate automatic computerized wheeze detection (CWD) in determining bronchial hyperreactivity (BHR) in young infants with prolonged cough, and its correlation with the subsequent development of wheezing. (6) A total of 28 infants who were 4 to 24 months old and had prolonged cough (i.e., >2 months) were included in the study. Twenty of these infants (71.4%) had BHR as determined by a positive acoustic bronchial provocation test (CPT) result. In 11 of these 20 tests, the CWD occurred earlier, and in 9 tests it occurred at the same step as auscultation by a physician.
In 2007, Beck et al. evaluated the use of computerized quantification of wheezing and crackles compared to a clinical score in assessing the effect of inhaled albuterol or inhaled epinephrine in infants with RSV bronchiolitis. (7) Computerized lung sounds analysis with quantification of wheezing and crackles and a clinical score were used during a double blind, randomized, controlled nebulized treatment pilot study. Infants were randomized to receive a single dose of 1 mgr nebulized l-epinephrine or 2.5 mgr nebulized albuterol. Computerized quantification of wheezing and crackles (PulmoTrack) and a clinical score were performed prior to, 10 minutes post and 30 minutes post treatment. Results were analyzed with Student's t-test for independent samples, Mann-Whitney U test and Wilcoxon test. Fifteen children received albuterol and 12 received epinephrine. The groups were identical at baseline. Satisfactory lung sounds recording and analysis was achieved in all subjects. There was no significant change in objective quantification of wheezes and crackles or in the total clinical scores either within the groups or between the groups.
Prodhan et al. (2008) prospectively studies 11 patients in the pediatric intensive care unit. (8) A physician, nurses, and respiratory therapists (RTs) auscultated the patients and recorded their opinions about the presence of wheeze at baseline and then every hour for 6 hours. The clinician auscultated while the PulmoTrack recorded the lung sounds. The data were analyzed by a technician trained in interpretation of acoustic data and by a panel of experts blinded to the source of the recorded data, who scored all tracks for the presence or absence of wheeze. The degree of correlation among the expert panel, the staff, and the PulmoTrack was evaluated with the Kappa coefficient and McNemar's test. The determinations of the expert panel were taken as the true state (accepted standard). The PulmoTrack and expert panel were in agreement on detection of wheeze during inspiration, expiration, and the whole breath cycle; in all cases the Kappa coefficients were 0.54, 0.42, and 0.50 respectively. The PulmoTrack was significantly more sensitive than the physician (P =0.002), nurses (P <0.001), or RTs (P =0.001). However, the specificity of the PulmoTrack was not significantly different from that of the physician, nurses, or RTs.
A 2014 study by Puder et al. was designed to determine and validate optimal cut-off values for computerized wheeze detection, based on the assessment by trained clinicians of stored records of lung sounds, in infants aged <1 year. (9) Lung sounds in 120 sleeping infants, of median (interquartile range) postmenstrual age of 51 (44.5–67.5) weeks, were recorded on 144 test occasions by an automatic wheeze detection device (PulmoTrack®). The records were retrospectively evaluated by three trained clinicians blinded to the results. Optimal cut-off values for the automatically determined relative durations of inspiratory and expiratory wheezing were determined by receiver operating curve analysis, and sensitivity and specificity were calculated. The optimal cut-off values for the automatically detected durations of inspiratory and expiratory wheezing were 2% and 3%, respectively. These cutoffs had a sensitivity and specificity of 85.7% and 80.7%, respectively, for inspiratory wheezing and 84.6% and 82.5%, respectively, for expiratory wheezing. Inter-observer reliability among the experts was moderate, with a Fleiss’ Kappa (95% confidence interval) of 0.59 (0.57-0.62) for inspiratory and 0.54 (0.52 - 0.57) for expiratory wheezing. One study limitation was that all sound records were performed in a quiet lung function testing unit, therefore the quality of computerized wheeze detection in noisier clinical settings cannot be determined. Additionally, all infants included in the study were sedated for lung function testing, preventing a determination of the quality of computerized wheeze detection in awake and possibly restless infants.
Puder et al. (2016) evaluated the quality of respiratory sound recordings in young infants to determine whether the position of the sensor affected computerized wheeze detection, as the optimal location for the acoustic sensors is unknown. (10) Respiratory sounds were recorded over the left lateral chest wall and the trachea in 112 sleeping infants (median postmenstrual age: 49 weeks) on 129 test occasions using an automatic wheeze detection device (PulmoTrack®). Each recording lasted 10 minutes and the recordings were stored. A trained clinician retrospectively evaluated the recordings to determine sound quality and disturbances. The wheeze rates of all undisturbed tracheal and chest wall signals were compared using Bland-Altman plots. Comparison of wheeze rates measured over the trachea and the chest wall indicated strong correlation (r >0.93, p < 0.001), with a bias of 1% or less and limits of agreement of within 3% for the inspiratory wheeze rate and within 6% for the expiratory wheeze rate. However, sounds from the chest wall were more often affected by disturbances than sounds from the trachea (23% versus 6%, p < 0.001). The study suggests that in young infants, a better quality of lung sound recordings can be obtained with the tracheal sensor.
Summary of Evidence
To date, there is insufficient evidence from randomized controlled trials on the effectiveness of intermittent or continuous computerized wheeze detection/monitoring for the evaluation of lung sounds compared to auscultation and/or standard pulmonary function testing.
Practice Guidelines and Position Statements
No professional guidelines or position statements supporting the use of computerized wheeze detection/monitoring in the diagnosis and management of respiratory disease were identified.
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1. Shih-Hong Li, Bor-Shing Lin, Chen-Han Tsai, et al. Design of wearable breathing sound monitoring system for real-time wheeze detection. Sensors (Basel). 2017 Jan; 17(1):171. PMID 28106747
2. U.S. Food and Drug Administration (FDA) 510(k). PulmoTrack. 510(k) No. K980878. Rockville, MD: FDA. Dec 28, 1998. Available at <http://www.fda.gov> (accessed May 7, 2018).
3. U.S. Food and Drug Administration (FDA) 510(k). Personal Wheezometer. 510(k) K090863. Rockville, MD: FDA. Sep 21, 2009. Available at <http://www.fda.gov> (accessed May 7, 2018).
4. U.S. Food and Drug Administration (FDA) 510(k). Wholter. 510(k) No. K101022. Rockville, MD: FDA. Jul 9, 2010. Available at <http://www.fda.gov> (accessed May 7, 2018).
5. Manufacturer Product Information. AirSonea® FAQ. Available at <http://www.respiri.com> (last accessed May 7, 2018).
6. Bentur L, Beck R, Berkowitz D, et al. Adenosine bronchial provocation with computerized wheeze detection in young infants with prolonged cough: correlation with long-term follow-up. Chest. 2004 Oct; 126(4):1060-5. PMID 15486364
7. Beck R, Elias N, Shoval S, et al. Computerized acoustic assessment of treatment efficacy of nebulized epinephrine and albuterol in RSV bronchiolitis. BMC Pediatr. 2007 Jun 2; 7:22. PMID 17543129
8. Prodhan P, Dela Rosa RS, Shubina M, et al. Wheeze detection in the pediatric intensive care unit: comparison among physician, nurses, respiratory therapists, and a computerized respiratory sound monitor. Respir Care. 2008 Oct; 53(10):1304-9. PMID 18811991
9. Puder L, Fischer H, Silke W, et al. Validation of computerized wheeze detection in young infants during the first months of life. BMC Pediatr. 2014; 14:257. PMID 25296955
10. Puder LC, Wilitzki S, Buhrer C, et al. Computerized wheeze detection in young infants: comparison of signals from tracheal and chest wall sensors. Physiol Meas. 2016 Dec; 37(12):2170-2018. PMID 27869106
|10/1/2018||Document updated with literature review. Coverage expanded to address computerized wheeze detection/monitoring, including intermittent or continuous measurement, recording and interpretation of data. Title changed from: Acoustic Respiratory Management (ARM). References 1-4 and 6-10 added.|
|10/15/2017||Reviewed. No changes.|
|10/1/2016||Document updated with literature review. Coverage unchanged.|
|7/1/2015||Reviewed. No changes.|
|10/1/2014||Document updated with literature review. Coverage unchanged.|
|5/1/2011||New medical document. Acoustic respiratory management (ARM), including the measurement, recording and interpretation of data is considered experimental, investigational and unproven for the diagnosis and/or management of asthma, chronic cough and other respiratory disorders.|
|1/1/2011||New position statement. Acoustic respiratory management (ARM), including the measurement, recording and interpretation of data is considered experimental, investigational and unproven for the diagnosis and/or management of asthma, chronic cough and other respiratory disorders.|
|Title:||Effective Date:||End Date:|
|Acoustic Respiratory Management (ARM)||10-15-2017||09-30-2018|
|Acoustic Respiratory Management (ARM)||10-01-2016||10-14-2017|
|Acoustic Respiratory Management (ARM)||07-01-2015||09-30-2016|
|Acoustic Respiratory Management (ARM)||10-01-2014||06-30-2015|
|Acoustic Respiratory Management (ARM)||05-01-2011||09-30-2014|
|Acoustic Respiratory Management (ARM)||01-01-2011||04-30-2011|