Smartphone–Mediated, At-Home Telespirometry Vital Capacity (VC) Measurements in ALS: Point-of-Care Quality Assessment for Slow VC and Forced VC

Topic:

Clinical Trials

Poster Number: P273

Author(s):

George Slavinski, RRT, SUNY Upstate Medical University, Syracuse, New York, USA, Eufrosina I. Young, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Dongliang Wang, PhD, SUNY Upstate Medical University, Syracuse, New York, USA, Dragos Manta, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Birendra Sah, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Urvi Desai, MD, Atrium Health Neurosciences Institute, Charlotte, North Carolina, USA, Lena Deb, SUNY Upstate Medical University, Syracuse, New York, USA, Marielle Posmik, SUNY Upstate Medical University, Syracuse, New York, USA, Jeffrey Collins, RN, SUNY Upstate Medical University, Syracuse, New York, USA, Emma Blystone, SUNY Upstate Medical University, Syracuse, New York, USA, Jenny A. Meyer, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Bhavya Narapureddy, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Ahmed Ibrahim, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Grace Biso, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Darshana Vijaywargiya, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Sara Abdelhafiz, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Pradeep Chevula, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Takuya Kudo, MS, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan, Kinjal Patel, MHA, MBA, Mitsubishi Tanabe Pharma America, Inc., Jersey City, New Jersey, USA, Stephen Apple, MD, Mitsubishi Tanabe Pharma America, Inc., Jersey City, New Jersey, USA, Benjamin Rix Brooks, MD, Clinical Trials Planning LLC, Charlotte, North Carolina, USA

Background: Smartphone application–mediated at-home telespirometry (AHT) is being deployed to treat amyotrophic lateral sclerosis (ALS)-associated respiratory comorbidities. Forced vital capacity (FVC) measurements, previously manually evaluated by respiratory therapists, may now be assessed at the point-of-care (POC) by a software-based algorithm analyzing flow-volume-curve characteristics from the American Thoracic Society (ATS)/European Respiratory Society (ERS) 2019 Spirometry Guidelines. Each slow vital capacity (SVC) measurement is analyzed to achieve a plateau (volume change of ≤25 mL) in the last second of expiration. If a plateau is not reached, the expiratory time must be ≥15 seconds for acceptance.

Objectives: Compare POC quality assessment classifications of VCs measured with ZEPHYRx® Remote Respiratory Monitoring™ (RRM™) connected to the Breathe Easy application.

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 the MIR Spirobank® Smart Spirometer and the ZEPHYRx dashboard. POC SVC quality assessments generated by the ZEPHYRx dashboard were compared with FVC quality assessments reported in the pilot study. POC eSVC (54.4%) measurements were rated as grade A statistically significantly (P<0.0001) higher vs eFVC (18.8%) measurements in the pilot FVC study. POC eSVC (40.8 %) measurements were rated as grade B-U statistically significantly (P<0.0001) lower vs eFVC (73.3%) measurements. Conclusions: This is the first report evaluating software-assisted POC quality assessments of eSVC measurements compared with eFVC measurements using the ZEPHYRx RRM dashboard and MIR’s Spirobank Smart Spirometer connected to the Breathe Easy application according to ATS/ERS 2019 Guidelines. 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.