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

NCT06175455 | Unknown

• 1 other identifier: NFEC-2023-537
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Long Covid19

Keywords

coronavirus; diaphragm dysfunction; dynamic chest radiography; dyspnea

Outcome Measures

Primary Outcomes (1)

• diaphragm assessment

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

  5 months

Secondary Outcomes (1)

• Correlation between lung function and DCR

  5 months

Study Arms (2)

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

dynamic chest radiography DEVICE

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

Long Covid; control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).
• 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).

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Yudong

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Coronavirus Infections; Dyspnea

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Liu Laiyu, professor

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Laiyu, professor

CONTACT

+86 13632102245; liulaiyu@sina.com

Yu Dong, postgraduate

CONTACT

+86 15625868995; 949863680@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 19, 2023
• Study Start: November 10, 2023
• Primary Completion: March 10, 2024
• Study Completion: March 10, 2025
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)