Smartphone–Mediated, At-Home Telespirometry Vital Capacity (VC) Measurements in ALS: Point-of-Care Quality Assessment for Slow VC and Forced VC
George Slavinski1, Eufrosina Young1, Dongliang Wang1, Dragos Manta1, Birenda Sah1, Urvi Desai2, Lena Deb1, Marielle Posmik1, Jeffrey Collins1, Emma Blystone1, Jenny Meyer1, Bhavya Narapureddy1, Ahmed Ibrahim1, Grace Marie Biso1, Darshana Vijaywargiya1, Sara Abdelhafiz1, Pradeep Chevula1, Takuya Kudo3, Kinjal Patel4, Stephen Apple4, Benjamin Rix Brooks5
1SUNY Upstate Medical University, 2Atrium Health Neurosciences Institute, 3Mitsubishi Tanabe Pharma Corporation, 4Mitsubishi Tanabe Pharma America, Inc, 5Clinical Trials Planning LLC
Objective:
Compare point-of-care (POC) quality assessment classifications of vital capacities measured with ZEPHYRx® Remote Respiratory Monitoring™ (RRM™) connected to the Breathe Easy application.
Background:
Smartphone application–mediated at-home telespirometry (AHT) aims to treat ALS-associated respiratory comorbidities. Forced vital capacity (FVC), previously manually evaluated, may now be assessed at POC by a software-based algorithm analyzing flow-volume-curve characteristics from American Thoracic Society/European Respiratory Society 2019 Spirometry Guidelines.
Design/Methods:
Slow vital capacity (SVC) measurements are analyzed to achieve a plateau (volume change of ≤25 mL) in the last second of expiration. Expiratory time must be ≥15 seconds if a plateau is not reached.
Results:
Data sets (n=1538) representing the best erect SVC (eSVC) measurements in 98 subjects with ALS participating in a study of smartphone application–mediated, supervised AHT [NCT05106569] were compared with data sets (n=90) representing the best erect FVC (eFVC) measurements in 22 subjects with ALS participating in a pilot feasibility study of the ZEPHYRx Breathe Easy application combined with MIR Spirobank® Smart Spirometer and ZEPHYRx dashboard. POC SVC quality assessments generated by ZEPHYRx were compared with pilot study FVC quality assessments. POC eSVC (54.4%) were rated as grade A statistically significantly (P<0.0001) higher vs pilot study eFVC (18.8%). POC eSVC (40.8%) were rated as grade B-U statistically significantly (P<0.0001) lower vs eFVC (73.3%).
Conclusions:
This is the first report evaluating software-assisted POC quality assessments of eSVC measurements compared with eFVC measurements using the ZEPHYRx RRM dashboard, MIR’s Spirobank Smart Spirometer, and Breathe Easy application. eSVC measurements met POC repeatability benchmarks at a higher level than eFVC measurements. Although the populations were different, the smartphone application, turbine spirometer, and respiratory therapy teams were comparable and POC repeatability was statistically significantly higher with eSVC measurements. This observation provides evidence that SVC may be the better measurement choice for patients with ALS.
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