Pulmonary Ventilation Heterogeneity Determined by EIT During PFT in Subjects With Normal One-second Rates

NCT06407986 | Recruiting

• 1 other identifier: '2023-933-01'
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the demographic characteristics of normal one-second rates 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 normal one-second rates during pulmonary function testing. To investigate the distribution patterns of lung ventilation in individuals with normal one-second rates using this technique, and provide references and evidence for early screening, diagnosis, treatment monitoring, and prognostic evaluation.

Conditions

Lung Function Decreased

Outcome Measures

Primary Outcomes (2)

• regional FEV1

  They were calculated for each pixel within the lung areas by EIT data analysis

  one month

• regional FVC

  They were calculated for each pixel within the lung areas by EIT data analysis

  one month

Secondary Outcomes (2)

• St. George's Respiratory Questionnaire

  one month

• regional obstructive ratio（rOR）

  one month

Study Arms (2)

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

Interventions

pulmonary function test DIAGNOSTIC_TEST

Whether the estimated value of FEV1 and FVC is greater than 80%.

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

After using a bronchodilator, FEV1/FVC ≥70%.

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 FEV1/FVC less than 0.7 after a bronchiectasis test. 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

Respiratory Insufficiency

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

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
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: May 15, 2024
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)