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RecruitingNCT06477458Updated Jun 27, 2024

Deep Learning for Preoperative Pulmonary Assessment in Thoracic CT

An observational study in Elective Thoracic Surgery, Pulmonary Function and Deep Learning, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-27.

Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years to 75 Years
Sex
All
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Study summary

The trial was designed as a single-centre, non-interventional prospective observational study to utilize deep learning technology combined with computed tomography (CT) images to precisely predict the pulmonary function indicators of thoracic surgery preoperative patients.

Read the detailed description

Preoperative pulmonary function tests are crucial in assessing perioperative complications or mortality risks and providing decision support for thoracic surgery. However, traditional pulmonary function assessment methods have significant limitations, including long testing durations, difficulties in patient cooperation, high false-negative rates, and numerous contraindications. Thus, our study optimized the final model based on 1500 single inspiratory phase CTs by transferring model parameters trained on 500 dual-phase respiratory CTs, enhancing its predictive capabilities for pulmonary function. This adjustment suits real-world application demands, offering more convenient, comprehensive, and personalized preoperative pulmonary function assessment support. Our study optimized the final model based on 1500 single inspiratory phase CTs by transferring model parameters trained on 500 dual-phase respiratory CTs, enhancing its predictive capabilities for pulmonary function. This adjustment suits real-world application demands, offering more convenient, comprehensive, and personalized preoperative pulmonary function assessment support.

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Conditions studied

  • Elective Thoracic Surgery
  • Pulmonary Function
  • Deep Learning

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03

In context

Aortic Dissection

386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 183 across 180 observational studies indexed under Aortic Dissection.

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Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 158 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Elective Thoracic Surgery Patients

Inclusion criteria

  • (1) Signing of the informed consent form;
  • (2) Male or female, aged 18-75 years;
  • (3) Undergoing elective thoracic surgery;
  • (4) Good preoperative pulmonary function cooperation and complete reporting;
  • (5) Preoperative chest single/dual phase CT scans without significant artefacts and with complete imaging;
  • (6) The interval between preoperative pulmonary function and single/dual phase CT scans does not exceed one month.

Exclusion criteria

Exclusion Criteria:

  • (1) Poor preoperative pulmonary function cooperation or missing reports;
  • (2) Preoperative chest single/dual phase CT scans exhibit significant artefacts or image omission;
  • (3) The interval between preoperative pulmonary function and single/dual phase CT scans exceeds one month;
  • (4) Complication with severe respiratory disorders (such as lung transplantation, pneumothorax, giant bullae, etc.);
  • (5) Coexisting with other severe functional impairments;
  • (6) Patients with obstructive lesions such as airway or esophageal stenosis;
  • (7) Height beyond the predicted equation range (Female \< 1.45m; Male \< 1.55m);
  • (8) Medication use before pulmonary function testing that does not meet the cessation guidelines;
  • (9) Pulmonary function report quality graded D-F.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Single inspiratory phase cohort

    Patients in this cohort undergo single inspiratory phase CT and pulmonary function tests preoperatively.

    Other: Single inspiratory phase computed tomography.

  • Respiratory dual-phase cohort

    Patients in this cohort undergo respiratory dual-phase CT and pulmonary function tests preoperatively.

    Other: Respiratory dual-phase computed tomography.

Interventions

  • OtherSingle inspiratory phase computed tomography.

    Utilizing deep learning technology in conjunction with single inspiratory phase computed tomography images to accurately predict the pulmonary function indicators of preoperative thoracic surgery patients.

  • OtherRespiratory dual-phase computed tomography.

    Utilizing deep learning technology in conjunction with respiratory dual-phase computed tomography images to accurately predict the pulmonary function indicators of preoperative thoracic surgery patients.

06

What researchers measure

Primary outcomes

  1. Mean Absolute Error(MAE)

    Used to assess the discrepancy between pulmonary function predictions made by the deep learning algorithm and actual results obtained from pulmonary function tests (measured with a spirometer).

    Time frame: 2 years

Secondary outcomes

  1. Concordance Correlation Coefficient(CCC)

    Used to assess the discrepancy between pulmonary function predictions made by the deep learning algorithm and actual results obtained from pulmonary function tests (measured with a spirometer).

    Time frame: 2 years

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Study locations

1 of 1 sites recruiting
  • Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
    Guangzhou, Guangdong 510120, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06477458
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Collaborators
GE Healthcare
Responsible party
Jianxing He (Director, The First Affiliated Hospital of Guangzhou Medical University) — Principal investigator
First posted
Jun 27, 2024
Start date
Oct 1, 2023
Primary completion
Sep 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Jun 27, 2024

Study contacts

Jianxing He, MD
Contact
drjianxing.he@gmail.com
86-20-83337792
Jianxing He, MD
principal investigator · Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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