The Reliability of a Novel Structured Testing Device for Single-breath Lung Carbon Monoxide Uptake: A Randomized...

Area of Science:

• Pulmonary Function Testing
• Respiratory Diagnostics
• Medical Device Validation

Background:

• New domestic lung diffusing capacity testing instruments are emerging.
• Clinical validation of the MeHow MeAir 9000 spirometer is necessary.
• The MeAir 9000 features a novel turning valve structure.

Purpose of the Study:

• To evaluate the clinical reliability of the MeHow MeAir 9000 spirometer.
• To assess the accuracy of lung diffusing capacity measurements.
• To compare MeAir 9000 performance against a established device.

Main Methods:

• 166 participants (30 healthy, 68 ILD, 68 COPD) were enrolled.
• A crossover design compared MeAir 9000 with Jaeger MasterScreen Diffusion.
• Lung diffusing capacity for carbon monoxide (D_LCO) and D_LCO %pred were primary outcomes.

Main Results:

• High consistency was observed for D_LCO (CCC=0.988) and D_LCO %pred classification (ICCs 0.931–0.975).
• Secondary indicators showed fair to poor consistency.
• MeAir 9000 demonstrated better CH4 detection stability, while MasterScreen showed superior CO detection.

Conclusions:

• The MeHow MeAir 9000 spirometer offers high accuracy in lung diffusing capacity measurements.
• It reliably assesses the severity of diffusing capacity impairment.
• The device is suitable for clinical application in respiratory diagnostics.