Heterogeneity of Lung Ventilation Determined by EIT During PFT in Patients With PRISM

NCT06199258 | Recruiting

• 1 other identifier: 2023-933-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the demographic characteristics of PRISm population in patients with pulmonary function tests recommended by outpatient physicians. To investigate whether EIT can identify spatial and temporal heterogeneity of lung ventilation in individuals with PRISm during pulmonary function testing. To investigate the distribution patterns of lung ventilation in individuals with PRISm using this technique, and provide references and evidence for early screening, diagnosis, treatment monitoring, and prognostic evaluation.

Conditions

COPD

Outcome Measures

Primary Outcomes (3)

• GI

  EIT parameters

  one month

• time constant time constant in second

  EIT parameters

  one month

• abnormal area in percent time constant in second

  EIT parameters

  one month

Study Arms (3)

Normal lung function

Normal lung function: After using a bronchodilator, FEV1/FVC ≥70%, FEV1 and FVC ≥80% of reference values.

Diagnostic Test: pulmonary function test

Preserved ratio impaired spirometry

After using a bronchodilator, FEV1/FVC≥70%, FEV1 and/or FVC\<80% of reference values.

Diagnostic Test: pulmonary function test

Chronic obstructive pulmonary disease

After using a bronchodilator, FEV1/FVC \<70%.

Diagnostic Test: pulmonary function test

Interventions

pulmonary function test DIAGNOSTIC_TEST

pulmonary function testing

Chronic obstructive pulmonary disease; Normal lung function; Preserved ratio impaired spirometry

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Gender, age, height, weight, smoking history, reason for seeking medical care， medication history, history of oxygen therapy, comorbidities.

You may qualify if:

• Age ≥18 years old. Patients who need to complete lung function tests assessed by outpatient physicians.
• Patients willing to participate in the study and sign an informed consent form.

You may not qualify if:

• Patients with a history of lung diseases other than COPD, previous lung surgery, or radiation therapy.
• Patients who cannot be evaluated for EIT or who interfere with EIT results, such as implanted pacemakers/cardioverters.
• Patients who cannot complete EIT or may interfere with EIT results, such as those with implanted pacemakers/defibrillators.
• Patients who cannot complete lung function tests, such as myocardial infarction or shock in the past 3 months; severe heart failure or angina in the past 4 weeks，uncontrolled hypertension (systolic \>200mmHg, diastolic \>100mmHg)，severe hyperthyroidism etc.
• Vulnerable populations, including patients with mental illnesses, cognitive impairments, critically ill patients, illiterate, pregnant women, etc.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Huiqing Ge

  Sir Run Run Shaw Hospital

  STUDY CHAIR

Central Study Contacts

Jiayi Li

CONTACT

17326082419; 22218299@zju.edu.cn

Study Design

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

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 10, 2024
• Study Start: December 5, 2023
• Primary Completion: December 31, 2024
• Study Completion: July 1, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)