Clinical Data

In a groundbreaking multi-center study published in CHEST in Feb 2021, lung volumes measured with the MiniBox+™ were shown to be equivalent to body plethysmography (“body box”) in both healthy participants as well as those with lungs disease. MiniBox+ lung volumes were more reproducible and correlated better with body plethysmography than the other leading office-based techniques.

The study compared total lung capacity (TLC) measured by body plethysmography (TLCPleth) with TLC measured by MiniBox+ (TLCMB). Collaborating researchers from 5 medical centers in the US and Europe contributed comparative data from 266 participants – 197 with obstructive disorders, 33 with restrictive disorders, and 36 healthy.

For robustness, several body plethysmography devices were used in the study, manufactured by Medisoft, MGC Diagnostics, and Vyaire. All measurements conformed with ATS/ERS guidelines.

The results

The normalized standard deviation (NSD) between the TLCPleth and TLCMB was 7.0% in healthy participants. For patients with obstructive disease, the NSD ranged from 7.7 to 9.1% depending on disease severity. For patients with restrictive disease, the overall NSD was 10.3%. In all groups, there was no significant difference between the measurements taken by the MiniBox+ vs. the body box.

In 14 cases in this study, the patient’s final clinical diagnosis differed by device. In 10 of these cases, the final diagnosis correlated better with the physiologic pattern characterized by the TLCMB than by TLCPleth.

Mean Normalized Standard Difference (NSD)

% #published studies
Helium Dilution 15.3 6
Nitrogen washout 14.2 1
Computerized Tomography 13.1 4
MiniBox+ 8.9 1

Mean Normalized Standard Difference (NSD) for TLC data when compared with body plethysmography

Authors:

Kenneth Berger, MD1,2
Ori Adam, PhD3
Roberto Walter Dal Negro, MD4
David A Kaminsky, MD5
Robert J. Shiner, MD6
Felip Burgos, PhD7
Frans H.C de Jongh, PhD8
Inon Cohen, PhD
Jeffrey J. Fredberg, PhD9

1. Division of Pulmonary Critical Care and Sleep Medicine, NYU Grossman School of Medicine
2. Andre Counrnand Pulmonary Physiology Laboratory, Bellevue Hospital, New York City NY, USA
3. Institute of Earth Sciences, the Hebrew University, Jerusalem, Israel
4. Centro Nazionale Studi di Farmacoeconomia e Farmacoepidemiologia Respiratoria, CESFAR, Verona, Italy
5. Pulmonary and Critical Care Medicine, The University of Vermont Larner College of Medicine, Burlington, Vermont, USA
6. Herzliya Medical Center, Herzliya Pituach, Israel
7. Servicio de Pneumologia, Hospital Clinic, Instituto de Investigaciones Biomedicas August Pi I Sunyer (IDIBAPS), University of Barcelona, Barcelona Spain
8. Pulmonary function department, Medisch Spectrum Twente, Enschede, The Netherlands
9. Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston MA/USA