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RecruitingNCT06175455DD-COVID-19Updated Dec 26, 2023

Diaphragm Dysfunction After COVID-19 as Determined by Dynamic Chest Radiography

An observational study in Long Covid19, sponsored by Nanfang Hospital, Southern Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-26.

Sponsored by Nanfang Hospital, Southern Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 2 years 10 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
24
Ages
18 Years and older
Sex
All
01

Study summary

Dynamic chest radiography (DCR) is a rapid and easily performed technique that captures real-time continuous images of the moving chest. COVID-19 has led to various complications and long-term effects, with dyspnea being a common symptom experienced by many patients. Studies conducted abroad have indicated that dyspnea following a new coronavirus infection can be attributed to diaphragm dysfunction. This study using DCR aims to describe diaphragm function in patients after coronavirus disease (COVID-19).

Read the detailed description

It has been estimated that approximately 80% of individuals infected with the new coronavirus will experience one or more long-term symptoms following recovery, with dyspnea being a frequent clinical complaint. However, this dyspnea cannot be adequately made clear by conventional clinical diagnostic measures, including pulmonary function tests and cardiac evaluation.

Currently, 9 clinical studies have explored the relationship between diaphragm dysfunction and COVID-19 in a small number of samples. To evaluate diaphragmatic function, there are several examination methods currently available including transdiaphragmatic pressure measurement, diaphragmatic ultrasound, and neuroelectrophysiological examination. However, these methods pose challenges in terms of implementation and widespread use, as they require a considerable amount of time and user experience. Therefore, there is a substantial unmet clinical demand for these methods.

A recent technological advancement in this field is dynamic chest radiography (DCR), which is a low-dose imaging system capable of producing continuous moving images. Compared to traditional fluoroscopic techniques, dynamic chest radiography offers several advantages, including simplicity of operation, reduced radiation dose, and the ability to provide quantitative data on diaphragm and chest wall motion. It has been used to diagnose diaphragmatic dysfunction by effectively identifying paradoxical diaphragmatic movement.

In this study, patients who experienced persistent respiratory symptoms four weeks after COVID-19 underwent DCR to observe diaphragm function and determine its relationship to dyspnea and clinical detection. This research marks the first instance of using DCR to investigate diaphragm dysfunction following COVID-19. The study shows promising research potential in understanding the role of diaphragm abnormalities and addressing the limitations of traditional examination methods for assessing diaphragm function.

02

Conditions studied

  • Long Covid19

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Keywords

  • coronavirus
  • diaphragm dysfunction
  • dynamic chest radiography
  • dyspnea
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 24 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study will compare a group of adults (over 18 years) in the community who experience breathlessness as a result of long COVID with a control group of healthy volunteers who are matched in terms of age and sex.

Inclusion criteria

  • COVID-19 group:

    1. Voluntarily sign the informed consent form;
    2. Aged equal to or older than 18 years old, regardless of gender;
    3. Inpatients with COVID-19 who mainly complain of dyspnea, dyspnea If it persists or develops and lasts for more than 4 weeks after acute COVID-19, it is related to long COVID-19; (confirmed infection with COVID-19 through nucleic acid monitoring or hospital laboratory data);
    4. Lung function measurements have been completed during hospitalization due to diagnosis and treatment needs;
    5. Be able to cooperate in completing the dynamic chest X-ray (complete the positioning of the dynamic chest X-ray for 20 seconds, and breathe calmly and forcefully during this period; be able to hold breath for at least 7 seconds).
  • Control group:

    1. Voluntarily sign the informed consent form;
    2. Aged equal to or older than 18 years old, regardless of gender;
    3. People from the health examination center, and the age, gender are matched in the COVID-19 group and have no previous acute or chronic cardiopulmonary disease, no abnormalities in previous lung physical examinations and lung imaging examinations, and no history of infectious diseases in the past month;
    4. Physical examination items are required People who are suitable for ordinary chest X-ray examination;
    5. Be able to cooperate in completing dynamic chest X-ray (complete dynamic chest X-ray positioning for 20 seconds, during which period, breathe calmly and forcefully, and be able to hold breath for at least 7 seconds).

Exclusion criteria

Exclusion Criteria:

  • COVID-19 group:

    1. Not suitable to participate in this study;
    2. Combined with serious life-threatening diseases, such as cardiovascular and cerebrovascular diseases, lung cancer, airway obstruction, etc.;
    3. Combined with pneumothorax, pulmonary insufficiency, chronic disease, interstitial disease, lung surgery history or recent planned surgery;
    4. Mental disorder and unable to cooperate with the operator;
    5. Pregnant or lactating women;
    6. Major radiation related to the research within 12 months before consent Exposure (participating in previous studies involving radiation exposure, the research dose is limited to 0.4mSv);
    7. No evidence of having been infected with the new coronavirus;
    8. Unable to cooperate in completing dynamic chest X-rays;
    9. Unable to complete lung function measurements;
  • Control group:

    1. Not suitable to participate in this study;
    2. Patients with previous acute or chronic cardiopulmonary disease, previous lung physical examination, lung imaging examination abnormalities, within the past 1 month Have a history of infectious diseases;
    3. Mentally abnormal and unable to cooperate with the operator;
    4. Pregnant or lactating women;
    5. Significant radiation exposure related to the research within 12 months before consent (participation in previous research involving radiation exposure, The study dose is limited to 0.4mSv); 6) Unable to cooperate in completing dynamic chest X-ray;.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
24 participants (estimated)
Patient registry
No

Groups and cohorts

  • control

    Healthy, age and sex matched controls

    Device: dynamic chest radiography

  • Long Covid

    patients who experienced persistent respiratory symptoms four weeks after contracting COVID-19

    Device: dynamic chest radiography

Interventions

  • Devicedynamic chest radiography

    A recent technological advancement in this field is dynamic chest radiography (DCR), which is a low-dose imaging system capable of producing continuous moving images

06

What researchers measure

Primary outcomes

  1. diaphragm assessment

    observe the differences in dynamic chest X-ray measurements between patients with COVID-19 and normal people

    Time frame: 5 months

Secondary outcomes

  1. Correlation between lung function and DCR

    observe the correlationbetween lung function and DCR

    Time frame: 5 months

07

Study locations

1 of 1 sites recruiting
  • Yudong
    Guangzhou, Guangdong, China
    • yu dong, postgraduate · Contact · 949863680@qq.com · +86 15625868995
    • yu dong, postgraduate · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06175455
Lead sponsor
Nanfang Hospital, Southern Medical University
Responsible party
Sponsor
First posted
Dec 19, 2023
Start date
Nov 10, 2023
Primary completion
Mar 10, 2024 (estimated)
Completion
Mar 10, 2025 (estimated)
Last update
Dec 26, 2023

Study contacts

Liu Laiyu, professor
Contact
liulaiyu@sina.com
+86 13632102245
Yu Dong, postgraduate
Contact
949863680@qq.com
+86 15625868995
Liu Laiyu, professor
principal investigator · Nanfang Hospital, Southern Medical University

Oversight

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

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