Evaluation of an AR-Assisted System for Standardizing Spirometry

Evaluation of an Augmented Reality Assisted System for Standardizing Spirometry (AR-SPIRO Trial): Protocol for a Two-phase Validation and Randomized Controlled Trial

Spirometry is the gold-standard tool for diagnosing Chronic Obstructive Pulmonary Disease (COPD). However, its implementation in primary care is often limited by a shortage of qualified technicians and inconsistent testing quality. This study will use Augmented Reality (AR) glasses to provide real-time interaction and guidance to participants during spirometry. It will be designed as a two-phase study to evaluate the technical validity and clinical effectiveness of AR-assisted spirometry (AR-SPIRO) system.

The AR-SPIRO system includes a portable spirometer, an iPad for data processing, and AR glasses for visual and voice instructions. In phase 1, 60 participants will undergo spirometry under two guidance modes (AR-assisted guidance and senior technician-led guidance) at the China-Japan Friendship Hospital. Researchers will compare the quality grades from both methods. If the agreement score (Kappa) is 0.7 or higher, the study will move to the phase 2. In phase 2, 650 people will participate at 14 primary care medical institutions. They will be randomly assigned in a 1:1 ratio to either the intervention (AR-assisted guidance) or the control group (routine guidance by primary-care technicians).

Inclusion Criteria:

Phase 1

• Age ≥ 18 years.
• Able to provide written informed consent.

Phase 2

• Age ≥ 40 years.
• Cumulative smoking history of ≥10 pack-years or history of biomass fuel exposure for ≥10 years.
• Able to provide written informed consent.

Exclusion Criteria (both two phase):

• Presence of absolute or relative contraindications to spirometry.
• Current pregnancy.
• Severe vision or hearing impairments that preclude the effective use of Augmented Reality (AR) glasses.