Long Covid19DD-COVID-19NCT06175455
Diaphragm Dysfunction After COVID-19 as Determined by Dynamic Chest Radiography
An observational study of Long Covid19, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Long Covid19
- What is being tested?
- dynamic chest radiography
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2023to 10 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- COVID-19 group:
- Voluntarily sign the informed consent form;
- Aged equal to or older than 18 years old, regardless of gender;
- 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);
- Lung function measurements have been completed during hospitalization due to diagnosis and treatment needs;
- 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).
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- Control group:
- Voluntarily sign the informed consent form;
- Aged equal to or older than 18 years old, regardless of gender;
- 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;
- Physical examination items are required People who are suitable for ordinary chest X-ray examination;
- 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).
Who cannot join
- COVID-19 group:
- Not suitable to participate in this study;
- Combined with serious life-threatening diseases, such as cardiovascular and cerebrovascular diseases, lung cancer, airway obstruction, etc.;
- Combined with pneumothorax, pulmonary insufficiency, chronic disease, interstitial disease, lung surgery history or recent planned surgery;
- Mental disorder and unable to cooperate with the operator;
- Pregnant or lactating women;
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- 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);
- No evidence of having been infected with the new coronavirus;
- Unable to cooperate in completing dynamic chest X-rays;
- Unable to complete lung function measurements；
- Control group:
- Not suitable to participate in this study;
- 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;
- Mentally abnormal and unable to cooperate with the operator;
- Pregnant or lactating women;
- 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;.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yudong
Guangzhou, Guangdong
yu dong, postgraduate, +86 15625868995, 949863680@qq.com
yu dong, postgraduate
About this study
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.
- Conditions
- Long Covid19
- Being tested
- dynamic chest radiography
- Keywords
- coronavirus, diaphragm dysfunction, dynamic chest radiography, dyspnea
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Coronavirus Infections, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic chest radiographyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| control | Healthy, age and sex matched controls Receives: Device: dynamic chest radiography | |
| Long Covid | patients who experienced persistent respiratory symptoms four weeks after contracting COVID-19 Receives: Device: dynamic chest radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
diaphragm assessment
observe the differences in dynamic chest X-ray measurements between patients with COVID-19 and normal people
Measured: 5 months
Secondary outcomes (1)
Correlation between lung function and DCR
observe the correlationbetween lung function and DCR
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start10 Nov 2023
- Primary completion10 Mar 2024 (estimated)
- Study completion10 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liu Laiyu, professor, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175455
- Sponsor's protocol ID
- NFEC-2023-537
- Acronym
- DD-COVID-19
- Status last verified
- Dec 2023
- First submitted
- 14 Dec 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragm Dysfunction After COVID-19 as Determined by Dynamic Chest Radiography
- ClinicalTrials.gov ID
- NCT06175455
- Acronym / sponsor ID
- DD-COVID-19 / NFEC-2023-537
- Conditions
- Long Covid19
- Keywords
- coronavirus, diaphragm dysfunction, dynamic chest radiography, dyspnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 10 Mar 2024 (estimated)
- Study completion
- 10 Mar 2025 (estimated)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | Device: dynamic chest radiographyHealthy, age and sex matched controls |
| Long Covid | – | Device: dynamic chest radiographypatients who experienced persistent respiratory symptoms four weeks after contracting COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- COVID-19 group:
- Control group:
Key exclusion criteria (16 listed)
- COVID-19 group:
- Control group:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dynamic chest radiographyA recent technological advancement in this field is dynamic chest radiography (DCR), which is a low-dose imaging system capable of producing continuous moving images | Device | Long Covid, control |
Primary outcome
diaphragm assessment
Time frame: 5 months
observe the differences in dynamic chest X-ray measurements between patients with COVID-19 and normal people
1 secondary outcome
Correlation between lung function and DCR
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liu Laiyu, professor principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long Covid19, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu Laiyu, professor (+86 13632102245, liulaiyu@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diaphragm assessment (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.