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临床试验/NCT06407986
NCT06407986招募中不适用

Pulmonary Ventilation Heterogeneity Determined by Electrical Impedance Tomography During Pulmonary Function Testing in Subjects With Normal One-second Rates

Sir Run Run Shaw Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
regional FEV1

研究概览

简要总结

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.

详细描述

In the GOLD 2023 guidelines, a newly introduced term called "Preserved Ratio Impaired Spirometry (PRISm)" refers to patients who have a normal forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio (FEV1/FVC≥0.7, after bronchodilator use), but exhibit impaired pulmonary ventilation function with FEV1 and/or FVC values below 80% of the predicted value. In the past, these patients were often classified as GOLD U or restrictive ventilatory impairment. In recent years, several large cross-sectional and longitudinal studies on PRISm have revealed its high prevalence, ranging from 5-20% due to population heterogeneity. Notably, approximately 10% to 40% of patients with PRISm tend to develop chronic obstructive pulmonary disease (COPD), resulting in frequent healthcare utilization. Moreover, subjects with normal lung function are also at risk of converting to PRISm during long-term follow-up. Studies have found that such patients are associated with increased respiratory symptoms, reduced quality of life, and increased burden of cardiovascular disease. A recent meta-analysis showed a significant increased risk of all-cause, cardiovascular, and respiratory-related mortality risk in PRISm patients. Currently, there are no diagnostic and treatment guidelines for PRISm, but studies highlights the importance of screening and identifying PRISm, with follow-up and early intervention if necessary.

Electrical Impedance Tomography (EIT) is an emerging imaging technology developing rapidly in recent years, with many advantages such as non-invasive, non-radiation and simple operation. Its principle is to measure the voltage or current signals through electrodes on the body surface, and then reconstructing images of the distribution of impedance changes. This technology is widely used in pulmonary diseases, including monitoring lung ventilation distribution, blood perfusion, and titration of positive end-expiratory pressure. EIT images have high spatial and temporal resolution, can display physiological and pathological changes in real time based on breathing. In 2022, China issued the clinical application consensus of electrical impedance tomography in critical respiratory management, further promoting the application of this technology in respiratory management. However, the number of clinical studies on EIT in identifying airway obstruction in COPD patients is limited. It has been proven that in COPD patients, EIT combined with pulmonary function tests can evaluate the spatial and temporal distribution of lung capacity in different regions and identify pathologically induced ventilation heterogeneity. At present, the pathophysiological mechanism of PRISm is still under discussion. Studies have found that PRISm is related to small airway dysfunction (SAD) and decreased total lung capacity. Computed Tomography (CT) can be used to evaluate small airway function and observe the morphological and structural changes of lung tissue, but it has but it has some disadvantages such as long duration and radiation exposure. Therefore, EIT may be a good choice for rapidly assessing regional lung function in PRISm patients. Due to the scarcity of EIT in PRISm studies, investigators have initiated a clinical study to evaluate whether ventilation heterogeneity in PRISm patients can be obtained through the combination of EIT and pulmonary function tests.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

regional FEV1

时间窗: one month

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

regional FVC

时间窗: one month

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

次要结局

  • regional obstructive ratio(rOR)(one month)
  • St. George's Respiratory Questionnaire(one month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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