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

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).

Study Overview

• Status: Recruiting
• Conditions: Long Covid19
• Intervention / Treatment: Device: dynamic chest radiography

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 Type: Observational
• Enrollment (Estimated): 24

Contacts and Locations

• Study Contact: Name: Liu Laiyu, professor; Phone Number: +86 13632102245; Email: liulaiyu@sina.com
• Study Contact Backup: Name: yu dong, postgraduate; Phone Number: +86 15625868995; Email: 949863680@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Yudong
      • Contact: yu dong, postgraduate; Phone Number: +86 15625868995; Email: 949863680@qq.com
      • Principal Investigator: yu dong, postgraduate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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:

• 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;.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control; Healthy, age and sex matched controls	Device: dynamic 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
Long Covid; patients who experienced persistent respiratory symptoms four weeks after contracting COVID-19	Device: dynamic 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diaphragm assessment	observe the differences in dynamic chest X-ray measurements between patients with COVID-19 and normal people	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between lung function and DCR	observe the correlationbetween lung function and DCR	5 months

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University
• Investigators: Principal Investigator: Liu Laiyu, professor, Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Estimated): March 10, 2024
• Study Completion (Estimated): March 10, 2025

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 19, 2023

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: coronavirus; dyspnea; diaphragm dysfunction; dynamic chest radiography
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: NFEC-2023-537

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No