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A multicenter randomized trial based on CT deep learning algorithm for predicting FEV1 and FVC: Two-stage evaluation of non-inferiority and impact on clinical decision-making

A multicenter randomized trial based on CT deep learning algorithm for predicting FEV1 and FVC: Two-stage evaluation of non-inferiority and impact on clinical decision-making

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600117374
Enrollment
Unknown
Registered
2026-01-23
Start date
2026-01-25
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Gold Standard:Gold standard pulmonary function test

Sponsors

Changhai Hospital, The Navy Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 18 to 90 years old 2. Plan to undergo chest CT examination and can complete pulmonary function test on the same day or within 24 hours thereafter 3. Have the ability to give informed consent 4. Can be evaluated by the physician to attempt diaphragmatic breathing training

Exclusion criteria

Exclusion criteria: 1. Acute respiratory failure: According to the guidelines of ATS/ERS and others, it is defined as arterial partial pressure of oxygen (PaO2) 30 breaths per minute, or requiring invasive ventilation support. 2. Within the past 14 days, has undergone major thoracic surgery. 3. Pregnant or lactating women. 4. Inadequate quality of CT images (presence of severe metal artifacts, motion artifacts, or significant insufficient inhalation). 5. Has absolute contraindications for pulmonary function tests or has been judged by the physician not suitable for the test.

Design outcomes

Primary

MeasureTime frame
Mean difference between AI-predicted values and measured pulmonary function values (FEV1, FVC);Correlation coefficient;

Secondary

MeasureTime frame
GOLD classification;Decision Change Rate;Process efficiency;Patient experience;Agreement;Calibration;

Countries

China

Contacts

Public ContactBian Yun

Changhai Hospital, The Navy Military Medical University

bianyun2012@foxmail.com+86 138 1635 7024

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026